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<1>
Accession Number
369592413
Title
What is the optimum adjunctive reperfusion strategy for primary
percutaneous coronary intervention?.
Source
The Lancet. 382 (9892) (pp 633-643), 2013. Date of Publication: 2013.
Author
Curzen N.; Gurbel P.A.; Myat A.; Bhatt D.L.; Redwood S.R.
Institution
(Curzen) Wessex Cardiothoracic Unit, University Hospital Southampton, NHS
Foundation Trust, Southampton SO16 6YD, United Kingdom
(Gurbel) Sinai Center for Thrombosis Research, Cardiac Catheterisation
Laboratory, Sinai Hospital of Baltimore, Baltimore, MD, United States
(Myat, Redwood) King's College London, BHF Centre of Research Excellence,
St Thomas' Hospital, London, United Kingdom
(Bhatt) VA Boston Healthcare System, Brigham and Women's Hospital, Harvard
Medical School, Boston, MA, United States
Publisher
Elsevier B.V.
Abstract
Acute ST-segment elevation myocardial infarction (STEMI) is a dynamic,
thrombus-driven event. As understanding of its pathophysiology has
improved, the central role of platelets in initiation and orchestration of
this process has become clear. Key components of STEMI include formation
of occlusive thrombus, mediation and ultimately amplification of the local
vascular inflammatory response resulting in increased vasoreactivity,
oedema formation, and microvascular obstruction. Activation,
degranulation, and aggregation of platelets are the platforms from which
these components develop. Therefore, prompt, potent, and predictable
antithrombotic therapy is needed to optimise clinical outcomes after
primary percutaneous coronary intervention. We review present
pharmacological and mechanical adjunctive therapies for reperfusion and
ask what is the optimum combination when primary percutaneous coronary
intervention is used as the mode of revascularisation in patients with
STEMI.

<2>
Accession Number
369592411
Title
Cardioprotective and prognostic effects of remote ischaemic
preconditioning in patients undergoing coronary artery bypass surgery: A
single-centre randomised, double-blind, controlled trial.
Source
The Lancet. 382 (9892) (pp 597-604), 2013. Date of Publication: 2013.
Author
Thielmann M.; Kottenberg E.; Kleinbongard P.; Wendt D.; Gedik N.; Pasa S.;
Price V.; Tsagakis K.; Neuhauser M.; Peters J.; Jakob H.; Heusch G.
Institution
(Thielmann, Wendt, Pasa, Price, Tsagakis, Jakob) Department of Thoracic
and Cardiovascular Surgery, Universitatsklinikum Essen, Essen, Germany
(Kottenberg, Peters) Klinik Fur Anasthesiologie und Intensivmedizin,
Universitatsklinikum Essen, Essen, Germany
(Kleinbongard, Gedik, Heusch) Institut Fur Pathophysiologie,
Universitatsklinikum Essen, Hufelandstrasse 55, 45122 Essen, Germany
(Neuhauser) Department of Mathematics and Technology, Koblenz University
of Applied Science, Remagen, Germany
Publisher
Elsevier B.V.
Abstract
Background Remote ischaemic preconditioning has been associated with
reduced risk of myocardial injury after coronary artery bypass graft
(CABG) surgery. We investigated the safety and efficacy of this procedure.
Methods Eligible patients were those scheduled to undergo elective
isolated first-time CABG surgery under cold crystalloid cardioplegia and
cardiopulmonary bypass at the West-German Heart Centre, Essen, Germany,
between April, 2008, and October, 2012. Patients were prospectively
randomised to receive remote ischaemic preconditioning (three cycles of 5
min ischaemia and 5 min reperfusion in the left upper arm after induction
of anaesthesia) or no ischaemic preconditioning (control). The primary
endpoint was myocardial injury, as reflected by the geometric mean area
under the curve (AUC) for perioperative concentrations of cardiac troponin
I (cTnI) in serum in the first 72 h after CABG. Mortality was the main
safety endpoint. Analysis was done in intention-to-treat and per-protocol
populations. This trial is registered with ClinicalTrials.gov, number
NCT01406678. Findings 329 patients were enrolled. Baseline characteristics
and perioperative data did not differ between groups. cTnI AUC was 266
ng/mL over 72 h (95% CI 237-298) in the remote ischaemic preconditioning
group and 321 ng/mL (287-360) in the control group. In the
intention-to-treat population, the ratio of remote ischaemic
preconditioning to control for cTnI AUC was 0.83 (95% CI 0.70-0.97,
p=0.022). cTnI release remained lower in the per-protocol analysis (0.79,
0.66-0.94, p=0.001). All-cause mortality was assessed over 1.54 (SD 1.22)
years and was lower with remote ischaemic preconditioning than without
(ratio 0.27, 95% CI 0.08-0.98, p=0.046). Interpretation Remote ischaemic
preconditioning provided perioperative myocardial protection and improved
the prognosis of patients undergoing elective CABG surgery.

<3>
Accession Number
368421813
Title
CABG or stents in coronary artery disease: End of the debate?.
Source
The Lancet. 381 (9867) (pp 605-607), 2013. Date of Publication: February
2013.
Author
Taggart D.P.
Institution
(Taggart) Nuffield Department of Surgical Sciences, Oxford University,
John Radcliffe Hospital, Oxford OX3 9DU, United Kingdom
Publisher
Elsevier B.V.

<4>
Accession Number
368421812
Title
Coronary artery bypass graft surgery versus percutaneous coronary
intervention in patients with three-vessel disease and left main coronary
disease: 5-year follow-up of the randomised, clinical SYNTAX trial.
Source
The Lancet. 381 (9867) (pp 629-638), 2013. Date of Publication: February
2013.
Author
Mohr F.W.; Morice M.-C.; Kappetein A.P.; Feldman T.E.; Stahle E.; Colombo
A.; MacK M.J.; Holmes Jr. D.R.; Morel M.-A.; Van Dyck N.; Houle V.M.;
Dawkins K.D.; Serruys P.W.
Institution
(Mohr) Herzzentrum Universitat Leipzig, 04289 Leipzig, Germany
(Morice) Hopital Prive Jacques Cartier, Massy, France
(Kappetein, Serruys) Erasmus University Medical Center Rotterdam,
Rotterdam, Netherlands
(Feldman) Evanston Hospital, Evanston, IL, United States
(Stahle) University Hospital Uppsala, Uppsala, Sweden
(Colombo) San Raffaele Scientific Institute, Milan, Italy
(MacK) Heart Hospital Baylor Plano, Baylor Healthcare System, Dallas, TX,
United States
(Holmes Jr.) Mayo Clinic, Rochester, MN, United States
(Morel) Cardialysis, Rotterdam, Netherlands
(Van Dyck, Houle, Dawkins) Boston Scientific, Natick, MA, United States
Publisher
Elsevier B.V.
Abstract
Background We report the 5-year results of the SYNTAX trial, which
compared coronary artery bypass graft surgery (CABG) with percutaneous
coronary intervention (PCI) for the treatment of patients with left main
coronary disease or three-vessel disease, to confirm findings at 1 and 3
years. Methods The randomised, clinical SYNTAX trial with nested
registries took place in 85 centres in the USA and Europe. A cardiac
surgeon and interventional cardiologist at each centre assessed
consecutive patients with de-novo three-vessel disease or left main
coronary disease to determine suitability for study treatments. Eligible
patients suitable for either treatment were randomly assigned (1:1) by an
interactive voice response system to either PCI with a first-generation
paclitaxel-eluting stent or to CABG. Patients suitable for only one
treatment option were entered into either the PCI-only or CABG-only
registries. We analysed a composite rate of major adverse cardiac and
cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier
analysis on an intention-to-treat basis. This study is registered with
ClinicalTrials.gov, number NCT00114972. Findings 1800 patients were
randomly assigned to CABG (n=897) or PCI (n=903). More patients who were
assigned to CABG withdrew consent than did those assigned to PCI (50 vs
11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26*9%
in the CABG group and 37*3% in the PCI group (p<0*0001). Estimates of
myocardial infarction (3*8% in the CABG group vs 9*7% in the PCI group;
p<0*0001) and repeat revascularisation (13*7% vs 25*9%; p<0*0001) were
significantly increased with PCI versus CABG. All-cause death (11*4% in
the CABG group vs 13*9% in the PCI group; p=0*10) and stroke (3*7% vs
2*4%; p=0*09) were not significantly different between groups. 28*6% of
patients in the CABG group with low SYNTAX scores had MACCE versus 32*1%
of patients in the PCI group (p=0*43) and 31*0% in the CABG group with
left main coronary disease had MACCE versus 36*9% in the PCI group
(p=0*12); however, in patients with intermediate or high SYNTAX scores,
MACCE was significantly increased with PCI (intermediate score, 25*8% of
the CABG group vs 36*0% of the PCI group; p=0*008; high score, 26*8% vs
44*0%; p<0*0001). Interpretation CABG should remain the standard of care
for patients with complex lesions (high or intermediate SYNTAX scores).
For patients with less complex disease (low SYNTAX scores) or left main
coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable
alternative. All patients with complex multivessel coronary artery disease
should be reviewed and discussed by both a cardiac surgeon and
interventional cardiologist to reach consensus on optimum treatment.
Funding Boston Scientific.

<5>
Accession Number
368421811
Title
Anatomical and clinical characteristics to guide decision making between
coronary artery bypass surgery and percutaneous coronary intervention for
individual patients: Development and validation of SYNTAX score II.
Source
The Lancet. 381 (9867) (pp 639-650), 2013. Date of Publication: February
2013.
Author
Farooq V.; Van Klaveren D.; Steyerberg E.W.; Meliga E.; Vergouwe Y.;
Chieffo A.; Kappetein A.P.; Colombo A.; Holmes Jr. D.R.; MacK M.; Feldman
T.; Morice M.-C.; Stahle E.; Onuma Y.; Morel M.-A.; Garcia-Garcia H.M.;
Van Es G.A.; Dawkins K.D.; Mohr F.W.; Serruys P.W.
Institution
(Farooq, Onuma, Garcia-Garcia, Serruys) Thoraxcenter, Erasmus University
Medical Center, Rotterdam, Netherlands
(Van Klaveren, Steyerberg, Vergouwe) Department of Public Health, Erasmus
University Medical Center, Rotterdam, Netherlands
(Kappetein) Department of Cardiothoracic Surgery, Erasmus University
Medical Center, Rotterdam, Netherlands
(Meliga) AO Ordine Mauriziano Umberto i, Turin, Italy
(Chieffo, Colombo) San Raffaele Scientific Institute, Milan, Italy
(Holmes Jr.) Mayo Clinic, Rochester, MN, United States
(MacK) Heart Hospital Baylor Plano, Baylor Healthcare System, Dallas, TX,
United States
(Feldman) Evanston Hospital, Evanston, IL, United States
(Morice) Hopital Prive Jacques Cartier, Massy, France
(Stahle) University Hospital Uppsala, Uppsala, Sweden
(Morel, Garcia-Garcia, Van Es) Cardialysis, Rotterdam, Netherlands
(Dawkins) Boston Scientific Corporation, Natick, MA, United States
(Mohr) Herzzentrum Universitat Leipzig, Leipzig, Germany
Publisher
Elsevier B.V.
Abstract
Background The anatomical SYNTAX score is advocated in European and US
guidelines as an instrument to help clinicians decide the optimum
revascularisation method in patients with complex coronary artery disease.
The absence of an individualised approach and of clinical variables to
guide decision making between coronary artery bypass graft surgery (CABG)
and percutaneous coronary intervention (PCI) are limitations of the SYNTAX
score. SYNTAX score II aimed to overcome these limitations. Methods SYNTAX
score II was developed by applying a Cox proportional hazards model to
results of the randomised all comers SYNTAX trial (n=1800). Baseline
features with strong associations to 4-year mortality in either the CABG
or the PCI settings (interactions), or in both (predictive accuracy), were
added to the anatomical SYNTAX score. Comparisons of 4-year mortality
predictions between CABG and PCI were made for each patient.
Discriminatory performance was quantified by concordance statistics and
internally validated with bootstrap resampling. External validation was
done in the multinational all comers DELTA registry (n=2891), a
heterogeneous population that included patients with three-vessel disease
(26%) or complex coronary artery disease (anatomical SYNTAX score.33, 30%)
who underwent CABG or PCI. The SYNTAX trial is registered with
ClinicalTrials.gov, number NCT00114972. Findings SYNTAX score II contained
eight predictors: anatomical SYNTAX score, age, creatinine clearance, left
ventricular ejection fraction (LVEF), presence of unprotected left main
coronary artery (ULMCA) disease, peripheral vascular disease, female sex,
and chronic obstructive pulmonary disease (COPD). SYNTAX score II
significantly predicted a difference in 4-year mortality between patients
undergoing CABG and those undergoing PCI (p<inf>interaction</inf> 0.0037).
To achieve similar 4-year mortality after CABG or PCI, younger patients,
women, and patients with reduced LVEF required lower anatomical SYNTAX
scores, whereas older patients, patients with ULMCA disease, and those
with COPD, required higher anatomical SYNTAX scores. Presence of diabetes
was not important for decision making between CABG and PCI
(p<inf>interaction</inf> 0.67). SYNTAX score II discriminated well in all
patients who underwent CABG or PCI, with concordance indices for internal
(SYNTAX trial) validation of 0.725 and for external (DELTA registry)
validation of 0.716, which were substantially higher than for the
anatomical SYNTAX score alone (concordance indices of 0.567 and 0.612,
respectively). A nomogram was constructed that allowed for an accurate
individualised prediction of 4-year mortality in patients proposing to
undergo CABG or PCI. Interpretation Long-term (4-year) mortality in
patients with complex coronary artery disease can be well predicted by a
combination of anatomical and clinical factors in SYNTAX score II. SYNTAX
score II can better guide decision making between CABG and PCI than the
original anatomical SYNTAX score. Funding Boston Scientific Corporation.

<6>
Accession Number
362399416
Title
Intravenous enoxaparin or unfractionated heparin in primary percutaneous
coronary intervention for ST-elevation myocardial infarction: The
international randomised open-label ATOLL trial.
Source
The Lancet. 378 (9792) (pp 693-703), 2011. Date of Publication: August
20-26, 2011.
Author
Montalescot G.; Zeymer U.; Silvain J.; Boulanger B.; Cohen M.; Goldstein
P.; Ecollan P.; Combes X.; Huber K.; Pollack Jr. C.; Benezet J.-F.; Stibbe
O.; Filippi E.; Teiger E.; Cayla G.; Elhadad S.; Adnet F.; Chouihed T.;
Gallula S.; Greffet A.; Aout M.; Collet J.-P.; Vicaut E.
Institution
(Montalescot, Silvain, Collet) Institut de Cardiologie, CHU
Pitie-Salpetrire (AP-HP), Universite Paris 6, Paris, France
(Ecollan) SMUR, CHU Pitie-Salpetrire (AP-HP), Universite Paris 6, Paris,
France
(Zeymer) Herzzentrum Klinikum Ludwigshafen, Medizinische Klinik B,
Ludwigshafen, Germany
(Boulanger) SAMU, CH Bretagne Atlantique, Vannes, France
(Filippi) Cardiology Department, CH Bretagne Atlantique, Vannes, France
(Cohen) Division of Cardiology, Newark Beth Israel Medical Center, Newark,
NJ, United States
(Goldstein) SAMU, CHU Lille, France
(Combes) SAMU, Henri Mondor Hospital, Creteil, France
(Teiger) Cardiology Department, Henri Mondor Hospital, Creteil, France
(Huber) Department of Internal Medicine, Cardiology and Emergency
Medicine, Wilhelminenhospital, Vienna, Austria
(Pollack Jr.) Pennsylvania Hospital, University of Pennsylvania,
Philadelphia, PA, United States
(Benezet) SAMU, CH Caremeau, Nimes, France
(Cayla) Cardiology Department, CH Caremeau, Nimes, France
(Stibbe) SAMU, CH de Lagny, Lagny-sur-Marne, France
(Elhadad) Cardiology Department, CH de Lagny, Lagny-sur-Marne, France
(Adnet) SAMU, Hopital Avicenne, Bobigny, France
(Chouihed) SAMU, Hopital Central, Nancy, France
(Gallula) SMUR, Hopital Lariboisire, Paris, France
(Greffet) SAMU, Hopital Necker, Paris, France
(Aout, Vicaut) Unite de Recherche Clinique, Lariboisire Hospital (AP-HP),
Universite Paris 7, Paris, France
Publisher
Elsevier B.V.
Abstract
Background Primary percutaneous coronary intervention (PCI) for
ST-elevation myocardial infarction has traditionally been supported by
unfractionated heparin, which has never been directly compared with a new
anticoagulant using consistent anticoagulation and similar antiplatelet
strategies in both groups. We compared traditional heparin treatment with
intravenous enoxaparin in primary PCI. Methods In a randomised open-label
trial, patients presenting with ST-elevation myocardial infarction were
randomly assigned (1:1) to receive an intravenous bolus of 0.5 mg/kg of
enoxaparin or unfractionated heparin before primary PCI. Wherever
possible, medical teams travelling in mobile intensive care units
(ambulances) selected, randomly assigned (using an interactive voice
response system at the central randomisation centre), and treated
patients. Patients who had received any anticoagulant before randomisation
were excluded. Patients and caregivers were not masked to treatment
allocation. The primary endpoint was 30-day incidence of death,
complication of myocardial infarction, procedure failure, or major
bleeding. The main secondary endpoint was the composite of death,
recurrent acute coronary syndrome, or urgent revascularisation. Analysis
was by intention to treat. This trial is registered at ClinicalTrials.gov,
number NCT00718471. Findings 910 patients were assigned to treatment with
enoxaparin (n=450) or unfractionated heparin (n=460). The primary endpoint
occurred in 126 (28) patients after anticoagulation with enoxaparin versus
155 (34) patients on unfractionated heparin (relative risk [RR] 0.83, 95
CI 0.68-1.01, p=0.06). The incidence of death (enoxaparin, 17 [4] vs
heparin, 29 [6] patients; p=0.08), complication of myocardial infarction
(20 [4] vs 29 [6]; p=0.21), procedure failure (100 [26] vs 109 [28];
p=0.61), and major bleeding (20 [5] vs 22 [5]; p=0.79) did not differ
between groups. Enoxaparin resulted in a significantly reduced rate of the
main secondary endpoint (30 [7] vs 52 [11] patients; RR 0.59, 95 CI
0.38-0.91, p=0.015). Death, complication of myocardial infarction, or
major bleeding (46 [10] vs 69 [15] patients; p=0.03), death or
complication of myocardial infarction (35 [8] vs 57 [12]; p=0.02), and
death, recurrent myocardial infarction, or urgent revascularisation (23
[5] vs 39 [8]; p=0.04) were all reduced with enoxaparin. Interpretation
Intravenous enoxaparin compared with unfractionated heparin significantly
reduced clinical ischaemic outcomes without differences in bleeding and
procedural success. Therefore, enoxaparin provided an improvement in net
clinical benefit in patients undergoing primary PCI. Funding Direction de
la Recherche Clinique, Assistance Publique-Hopitaux de Paris;
Sanofi-Aventis. &#xa9; 2011 Elsevier Ltd.

<7>
Accession Number
358881173
Title
Fibrates in CVD: a step towards personalised medicine.
Source
The Lancet. 375 (9729) (pp 1847-1848), 2010. Date of Publication:
20100529/0604.
Author
Staels B.
Institution
(Staels) Universite Lille Nord de France, Lille, France
(Staels) U1011 Inserm, Lille, France
(Staels) Universite Droit et Sante de Lille, Lille, France
(Staels) Institut Pasteur de Lille, 59019 Lille cedex, France
Publisher
Elsevier B.V.

<8>
Accession Number
354810814
Title
Rivaroxaban versus placebo in patients with acute coronary syndromes
(ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial.
Source
The Lancet. 374 (9683) (pp 29-38), 2009. Date of Publication: 10 Jul 2009.
Author
Mega J.L.; Braunwald E.; Mohanavelu S.; Burton P.; Poulter R.; Misselwitz
F.; Hricak V.; Barnathan E.S.; Bordes P.; Witkowski A.; Markov V.;
Oppenheimer L.; Gibson C.M.
Institution
(Mega, Braunwald, Mohanavelu) TIMI Study Group, Boston, MA, United States
(Mega, Braunwald) Cardiovascular Division, Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, United States
(Burton, Barnathan, Oppenheimer) Johnson and Johnson Pharmaceutical
Research and Development, Raritan, NJ, United States
(Poulter) Royal Brisbane Hospital, Herston, QLD, Australia
(Misselwitz) Bayer Healthcare AG, Wuppertal, Germany
(Hricak) National Heart Institute, Bratislava, Slovakia
(Bordes) Hospital General Universitario Alicante, Alicante, Spain
(Witkowski) Institute of Cardiology, Warsaw, Poland
(Markov) State Institution Research Cardiology Institute, Tomsk, Russian
Federation
(Gibson) Cardiovascular Division, Beth Israel Hospital, Harvard Medical
School, Boston, MA, United States
Publisher
Elsevier B.V.
Abstract
Background: Rivaroxaban is an oral direct factor Xa inhibitor that has
been effective in prevention of venous thromboembolism in patients
undergoing elective orthopaedic surgery. However, its use after acute
coronary syndromes has not been investigated. In this setting, we assessed
the safety and efficacy of rivaroxaban and aimed to select the most
favourable dose and dosing regimen. <br/>Method(s): In this double-blind,
dose-escalation, phase II study, undertaken at 297 sites in 27 countries,
3491 patients stabilised after an acute coronary syndrome were stratified
on the basis of investigator decision to use aspirin only (stratum 1,
n=761) or aspirin plus a thienopyridine (stratum 2, n=2730). Participants
were randomised within each strata and dose tier with a block
randomisation method at 1:1:1 to receive either placebo or rivaroxaban (at
doses 5-20 mg) given once daily or the same total daily dose given twice
daily. The primary safety endpoint was clinically significant bleeding
(TIMI major, TIMI minor, or requiring medical attention); the primary
efficacy endpoint was death, myocardial infarction, stroke, or severe
recurrent ischaemia requiring revascularisation during 6 months. Safety
analyses included all participants who received at least one dose of study
drug; efficacy analyses were by intention to treat. This study is
registered with ClinicalTrials.gov, number NCT00402597. <br/>Finding(s):
Three patients in stratum 1 and 26 in stratum 2 never received the study
drug. The risk of clinically significant bleeding with rivaroxaban versus
placebo increased in a dose-dependent manner (hazard ratios [HRs] 2.21
[95% CI 1.25-3.91] for 5 mg, 3.35 [2.31-4.87] for 10 mg, 3.60 [2.32-5.58]
for 15 mg, and 5.06 [3.45-7.42] for 20 mg doses; p<0.0001). Rates of the
primary efficacy endpoint were 5.6% (126/2331) for rivaroxaban versus 7.0%
(79/1160) for placebo (HR 0.79 [0.60-1.05], p=0.10). Rivaroxaban reduced
the main secondary efficacy endpoint of death, myocardial infarction, or
stroke compared with placebo (87/2331 [3.9%] vs 62/1160 [5.5%]; HR 0.69,
[95% CI 0.50-0.96], p=0.0270). The most common adverse event in both
groups was chest pain (248/2309 [10.7%] vs 118/1153 [10.2%]).
<br/>Interpretation(s): The use of an oral factor Xa inhibitor in patients
stabilised after an acute coronary syndrome increases bleeding in a
dose-dependent manner and might reduce major ischaemic outcomes. On the
basis of these observations, a phase III study of low-dose rivaroxaban as
adjunctive therapy in these patients is underway. <br/>Funding(s): Johnson
& Johnson Pharmaceutical Research & Development and Bayer Healthcare AG.
&#xa9; 2009 Elsevier Ltd. All rights reserved.

<9>
Accession Number
354277424
Title
Percutaneous coronary interventions for non-acute coronary artery disease:
a quantitative 20-year synopsis and a network meta-analysis.
Source
The Lancet. 373 (9667) (pp 911-918), 2009. Date of Publication:
20090314/20.
Author
Trikalinos T.A.; Alsheikh-Ali A.A.; Tatsioni A.; Nallamothu B.K.; Kent
D.M.
Institution
(Trikalinos, Alsheikh-Ali, Tatsioni, Kent) Institute for Clinical Research
and Health Policy Studies, Tufts Medical Center, Boston, MA, United States
(Alsheikh-Ali) Division of Cardiology, Department of Medicine, Tufts
Medical Center, Boston, MA, United States
(Nallamothu) VA Health Services Research, Development Center of
Excellence, Ann Arbor VA Medical Center, Ann Arbor, MI, United States
Publisher
Elsevier B.V.
Abstract
Background: Over the past 20 years, percutaneous transluminal balloon
coronary angioplasty (PTCA), bare-metal stents (BMS), and drug-eluting
stents (DES) succeeded each other as catheter-based treatments for
coronary artery disease. We undertook a systematic overview of randomised
trials comparing these interventions with each other and with medical
therapy in patients with non-acute coronary artery disease.
<br/>Method(s): We searched Medline for trials contrasting at least two of
the four interventions (PTCA, BMS, DES, and medical therapy). Eligible
outcomes were death, myocardial infarction, coronary artery bypass
grafting, target lesion or vessel revascularisation, and any
revascularisation. Random effects meta-analyses summarised head-to-head
(direct) comparisons, and network meta-analyses integrated direct and
indirect evidence. <br/>Finding(s): 61 eligible trials (25 388 patients)
investigated four of six possible comparisons between the four
interventions; no trials directly compared DES with medical therapy or
PTCA. In all direct or indirect comparisons, succeeding advancements in
percutaneous coronary intervention did not produce detectable improvements
in deaths or myocardial infarction. The risk ratio (RR) for indirect
comparisons between DES and medical therapy was 0.96 (95% CI 0.60-1.52)
for death and 1.15 (0.73-1.82) for myocardial infarction. By contrast, we
recorded sequential significant reductions in target lesion or vessel
revascularisation with BMS compared with PTCA (RR 0.68 [0-60.0.77]) and
with DES compared with BMS (0.44 [0.35-0.56]). The RR for the indirect
comparison between DES and PTCA for target lesion or vessel
revascularisation was 0.30 (0.17-0.51). <br/>Interpretation(s): Sequential
innovations in the catheter-based treatment of non-acute coronary artery
disease showed no evidence of an effect on death or myocardial infarction
when compared with medical therapy. These results lend support to present
recommendations to optimise medical therapy as an initial management
strategy in patients with this disease. <br/>Funding(s): US National
Institutes of Health. &#xa9; 2009 Elsevier Ltd. All rights reserved.

<10>
Accession Number
354207805
Title
Prasugrel compared with clopidogrel in patients undergoing percutaneous
coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI
38): double-blind, randomised controlled trial.
Source
The Lancet. 373 (9665) (pp 723-731), 2009. Date of Publication:
20090228/0306.
Author
Montalescot G.; Wiviott S.D.; Braunwald E.; Murphy S.A.; Gibson C.M.;
McCabe C.H.; Antman E.M.
Institution
(Montalescot) Institute of Cardiology, INSERM U856, Universite Paris 6,
Paris, France
(Wiviott, Braunwald, Murphy, Gibson, McCabe, Antman) TIMI Study Group,
Cardiovascular Division, Department of Medicine, Boston, MA, United States
Publisher
Elsevier B.V.
Abstract
Background: Mechanical reperfusion with stenting for ST-elevation
myocardial infarction (STEMI) is supported by dual antiplatelet treatment
with aspirin and clopidogrel. Prasugrel, a potent and rapid-acting
thienopyridine, is a potential alternative to clopidogrel. We aimed to
assess prasugrel versus clopidogrel in patients undergoing percutaneous
coronary intervention (PCI) for STEMI. <br/>Method(s): We undertook a
double-blind, randomised controlled trial in 707 sites in 30 countries.
3534 participants presenting with STEMI were randomly assigned by
interactive voice response system either prasugrel (60 mg loading, 10 mg
maintenance [n=1769]) or clopidogrel (300 mg loading, 75 mg maintenance
[n=1765]) and were unaware of the allocation. The primary endpoint was
cardiovascular death, non-fatal myocardial infarction, or non-fatal
stroke. Efficacy analyses were by intention to treat. Follow-up was to 15
months, with secondary analyses at 30 days. This trial is registered with
ClinicalTrials.gov, number NCT00097591. <br/>Finding(s): At 30 days, 115
(6.5%) individuals assigned prasugrel had met the primary endpoint
compared with 166 (9.5%) allocated clopidogrel (hazard ratio 0.68 [95% CI
0.54-0.87]; p=0.0017). This effect continued to 15 months (174 [10.0%] vs
216 [12.4%]; 0.79 [0.65-0.97]; p=0.0221). The key secondary endpoint of
cardiovascular death, myocardial infarction, or urgent target vessel
revascularisation was also significantly reduced with prasugrel at 30 days
(0.75 [0.59-0.96]; p=0.0205) and 15 months (0.79 [0.65-0.97]; p=0.0250),
as was stent thrombosis. Treatments did not differ with respect to
thrombolysis in myocardial infarction (TIMI) major bleeding unrelated to
coronary-artery bypass graft (CABG) surgery at 30 days (p=0.3359) and 15
months (p=0.6451). TIMI life-threatening bleeding and TIMI major or minor
bleeding were also similar with the two treatments, and only TIMI major
bleeding after CABG surgery was significantly increased with prasugrel
(p=0.0033). <br/>Interpretation(s): In patients with STEMI undergoing PCI,
prasugrel is more effective than clopidogrel for prevention of ischaemic
events, without an apparent excess in bleeding. <br/>Funding(s): Daiichi
Sankyo and Eli Lilly. &#xa9; 2009 Elsevier Ltd. All rights reserved.

<11>
Accession Number
52845523
Title
Third-generation zotarolimus-eluting and everolimus-eluting stents in
all-comer patients requiring a percutaneous coronary intervention (DUTCH
PEERS): A randomised, single-blind, multicentre, non-inferiority trial.
Source
The Lancet. 383 (9915) (pp 413-423), 2014. Date of Publication: 2014.
Author
Von Birgelen C.; Sen H.; Lam M.K.; Danse P.W.; Jessurun G.A.J.; Hautvast
R.W.M.; Van Houwelingen G.K.; Schramm A.R.; Gin R.M.T.J.; Louwerenburg
J.W.; De Man F.H.A.F.; Stoel M.G.; Lowik M.M.; Linssen G.C.M.; Said
S.A.M.; Nienhuis M.B.; Verhorst P.M.J.; Basalus M.W.Z.; Doggen C.J.M.;
Tandjung K.
Institution
(Von Birgelen, Sen, Lam, Van Houwelingen, Louwerenburg, De Man, Stoel,
Lowik, Verhorst, Basalus, Tandjung) Department of Cardiology,
Thoraxcentrum Twente, 7513 ER Enschede, Netherlands
(Von Birgelen, Doggen) Department of Health Technology and Services
Research, University of Twente, Enschede, Netherlands
(Danse, Gin) Department of Cardiology, Rijnstate Hospital, Arnhem,
Netherlands
(Jessurun, Schramm) Department of Cardiology, Scheper Hospital, Emmen,
Netherlands
(Hautvast) Department of Cardiology, Medical Center Alkmaar, Alkmaar,
Netherlands
(Linssen, Said) Department of Cardiology, Hospital Group Twente, Almelo
and Hengelo, Netherlands
(Nienhuis) Department of Cardiology, Queen Beatrix Hospital, Winterswijk,
Netherlands
Publisher
Elsevier B.V.
Abstract
Background: Third-generation, permanent-polymer-based drug-eluting stents
with novel, flexible designs might be more easily delivered than previous
generations of stents in complex coronary lesions, but might be less
longitudinally stable. We aimed to assess the safety and efficacy in
all-comer patients of two third-generation stents that are often used
clinically, but that have not yet been compared, and one of which has not
previously been assessed in a randomised trial. <br/>Method(s): In this
investigator-initiated, single-blind, multicentre, randomised, two-arm,
non-inferiority trial, patients aged 18 years and older who required a
percutaneous coronary intervention with implantation of a drug-eluting
stent were recruited from four study sites in the Netherlands. We randomly
assigned patients by independently managed computer-generated allocation
sequences in a 1:1 ratio to receive either cobalt-chromium-based
zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA,
USA) or platinum-chromium-based everolimus-eluting stents (Promus Element,
Boston Scientific, Natick, MA, USA). Patients and analysts were masked to
the allocated stent, but treating clinicians were not. The primary
endpoint of target-vessel failure was a composite of safety (cardiac death
or target-vessel-related myocardial infarction) and efficacy
(target-vessel revascularisation) at 12 months, analysed by intention to
treat (with a non-inferiority margin of 3.6%). This trial is registered
with ClinicalTrials.gov, number NCT01331707. <br/>Finding(s): Between Nov
25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371
target lesions, were enrolled in the study. 370 (20%) patients presented
with ST-elevation myocardial infarction and 447 (25%) with
non-ST-elevation myocardial infarction. 906 patients were assigned to
receive zotarolimus-eluting stents and 905 to receive everolimus-eluting
stents. Ease of stent delivery was shown by very low numbers of patients
requiring treatment other than their assigned study treatment (six [1%] in
the zotarolimus-eluting stent group vs five [1%] in the everolimus-eluting
stent group; p=0.22). 12-month follow-up results were available for 1810
patients (one patient in the zotarolimus-eluting stent group withdrew
consent). The primary endpoint was met by 55 (6%) of 905 patients in the
zotarolimus-eluting stent group and 47 (5%) of 905 in the
everolimus-eluting stent group. The zotarolimus-eluting stent was
non-inferior to the everolimus-eluting stent (absolute risk diff erence
0.88%, 95% CI-1.24% to 3.01%; upper limit of one-sided 95% CI 2.69%;
non-inferiority p=0.006). We noted no significant between-group diff
erences in individual components of the primary endpoint. Definite stent
thrombosis occurred in three (0.3%) patients in the zotarolimus-eluting
stent group and six (0.7%) patients in the everolimus-eluting stent group
(p=0.34). Longitudinal stent deformation was seen only in the
everolimus-eluting stent group (nine [1.0%] of 905 vs 0 of 906, p=0.002;
nine of 1591 [0.6%] everolimus-eluting stents implanted became deformed),
but was not associated with any adverse events. <br/>Interpretation(s):
Both stents were similarly efficacious and safe, and provided excellent
clinical outcomes, especially in view of the large number of patients who
presented with acute myocardial infarctions. <br/>Funding(s): Boston
Scientific, Medtronic.

<12>
Accession Number
53053287
Title
Differential clinical outcomes after 1 year versus 5 years in a randomised
comparison of zotarolimus-eluting and sirolimus-eluting coronary stents
(the SORT OUT III study): A multicentre, open-label, randomised
superiority trial.
Source
The Lancet. 383 (9934) (pp 2047-2056), 2014. Date of Publication: 2014.
Author
Maeng M.; Tilsted H.H.; Jensen L.O.; Krusell L.R.; Kaltoft A.; Kelbaek H.;
Villadsen A.B.; Ravkilde J.; Hansen K.N.; Christiansen E.H.; Aaroe J.;
Jensen J.S.; Kristensen S.D.; Botker H.E.; Thuesen L.; Madsen M.; Thayssen
P.; Sorensen H.T.; Lassen J.F.
Institution
(Maeng, Jensen, Krusell, Kaltoft, Christiansen, Kristensen, Botker,
Thuesen, Lassen) Department of Cardiology, Aarhus University Hospital,
Brendstrupgaardsvej 100, 8200 Skejby, Aarhus, Denmark
(Tilsted, Villadsen, Ravkilde, Aaroe) Department of Cardiology, Aarhus
University Hospital, Aalborg Hospital, Aalborg, Denmark
(Hansen, Jensen, Thayssen) Department of Cardiology, Odense University
Hospital, Odense, Denmark
(Kelbaek) Department of Cardiology, Rigshospitalet, Copenhagen University
Hospital, Copenhagen, Denmark
(Jensen) Department of Cardiology, Gentofte University Hospital, Hellerup,
Denmark
(Madsen, Sorensen) Department of Clinical Epidemiology, Aarhus University
Hospital, Aarhus, Denmark
Publisher
Elsevier B.V.
Abstract
Background: In head-to-head comparisons of coronary drug-eluting stents,
the primary endpoint is traditionally assessed after 9-12 months. However,
the optimum timepoint for this assessment remains unclear. In this study,
we assessed clinical outcomes at up to 5 years' follow-up in patients who
received two different types of drug-eluting stents. <br/>Method(s): We
undertook this multicentre, open-label, randomised superiority trial at
five percutaneous coronary intervention centres in Denmark. We randomly
allocated 2332 eligible adult patients (>=18 years of age) with an
indication for drug-eluting stent implantation to the zotarolimus-eluting
Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the
sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson,
Warren, NJ, USA). Randomisation of participants was achieved by
computer-generated block randomisation and a telephone allocation service.
The primary endpoint of the SORT OUT III study was a composite of major
adverse cardiac events-cardiac death, myocardial infarction, and target
vessel revascularisation-at 9 months' follow-up. In this study, endpoints
included the occurrence of major adverse cardiac events and definite stent
thrombosis at follow-up times of up to 5 years. Analysis was by intention
to treat. The trial is registered with ClinicalTrials.gov, number
NCT00660478. <br/>Finding(s): We randomly allocated 1162 patients to
receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting
stent. At 5-year follow-up, rates of major adverse cardiac events were
similar in patients treated with both types of stents (zotarolimus-eluting
stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds
ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of
the directly contrasting results for rates of major adverse cardiac events
at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170
[3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at
follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95%
CI 0.59- 1.02; p=0.071). At 1-year follow-up, definite stent thrombosis
was more frequent after implantation of the zotarolimus-eluting stent
(13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34,
95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for
between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%]
vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36;
p=0.003). 26 of 88 (30%) target lesion revascularisations in the
zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up,
whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group
occurred during this follow-up period. <br/>Interpretation(s): The
superiority of sirolimus-eluting stents compared with zotarolimus-eluting
stents at 1-year follow-up was lost after 5 years. The traditional 1-year
primary endpoint assessment therefore might be insufficient to predict
5-year clinical outcomes in patients treated with coronary drug-eluting
stent implantation. <br/>Funding(s): Cordis and Medtronic.

<13>
Accession Number
52760284
Title
Intra-aortic balloon counterpulsation in acute myocardial infarction
complicated by cardiogenic shock (IABP-SHOCK II): Fi nal 12 month results
of a randomised, open-label trial.
Source
The Lancet. 382 (9905) (pp 1638-1645), 2013. Date of Publication: 2013.
Author
Thiele H.; Zeymer U.; Neumann F.-J.; Ferenc M.; Olbrich H.-G.; Hausleiter
J.; De Waha A.; Richardt G.; Hennersdorf M.; Empen K.; Fuernau G.; Desch
S.; Eitel I.; Hambrecht R.; Lauer B.; Bohm M.; Ebelt H.; Schneider S.;
Werdan K.; Schuler G.
Institution
(Thiele, Fuernau, Desch, Eitel, Schuler) University of Leipzig, Heart
Centre, Department of Internal Medicine/Cardiology, 04289 Leipzig, Germany
(Zeymer, Schneider) Klinikum Ludwigshafen, Institut fur
Herzinfarktforschung, Ludwigshafen, Germany
(Neumann) University of Freiburg, Heart Centre Bad Krozingen, Bad
Krozingen, Germany
(Ferenc, Olbrich) Asklepios Clinic Langen-Seligenstadt, Langen, Germany
(Hausleiter) Klinikum der Ludwig-Maximilians, Universitat Munchen, Munich,
Germany
(De Waha) German Heart Centre Munich, Munich, Germany
(Richardt) Heart Centre-Segeberger Kliniken, Bad Segeberg, Germany
(Hennersdorf) SLK Kliniken Heilbronn, Heilbronn, Germany
(Empen) Ernst-Moritz-Arndt University Greifswald, Greifswald, Germany
(Hambrecht) Klinikum Links der Weser, Bremen, Germany
(Lauer) Zentralklinik Bad Berka, Bad Berka, Germany
(Bohm) University Clinic of Saarland, Homburg/Saar, Germany
(Ebelt, Werdan) Martin-Luther University Halle-Wittenberg, Halle (Saale),
Germany
Publisher
Elsevier B.V.
Abstract
Background In current international guidelines the recommendation for
intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic
shock complicating acute myocardial infarction on the basis of registry
data. In the largest randomised trial (IABP-SHOCK II), IABP support did
not reduce 30 day mortality compared with control. However, previous
trials in cardiogenic shock showed a mortality benefi t only at extended
follow-up. The present analysis therefore reports 6 and 12 month results.
Methods The IABP-SHOCK II trial was a randomised, open-label, multicentre
trial. Patients with cardiogenic shock complicating acute myocardial
infarction who were undergoing early revascularisation and optimum medical
therapy were randomly assigned (1:1) to IABP versus control via a central
web-based system. The primary effi cacy endpoint was 30 day all-cause
mortality, but 6 and 12 month follow-up was done in addition to
quality-of-life assessment for all survivors with the Euroqol-5D
questionnaire. A masked central committee adjudicated clinical outcomes.
Patients and investigators were not masked to treatment allocation.
Analysis was by intention to treat. This trial is registered at
ClinicalTrials.gov, NCT00491036. Findings Between June 16, 2009, and March
3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of
595 patients completing 12 month follow-up, 155 (52%) of 299 patients in
the IABP group and 152 (51%) of 296 patients in the control group had died
(relative risk [RR] 1.01, 95% CI 0.86-1.18, p=0.91). There were no signifi
cant diff erences in reinfarction (RR 2.60, 95% CI 0.95-7.10, p=0.05),
recurrent revascularisation (0.91, 0.58- 1.41, p=0.77), or stroke (1.50,
0.25-8.84, p=1.00). For survivors, quality-of-life measures including
mobility, self-care, usual activities, pain or discomfort, and anxiety or
depression did not diff er signifi cantly between study groups.
Interpretation In patients undergoing early revas cularisation for
myocardial infarction complicated by cardiogenic shock, IABP did not
reduce 12 month all-cause mortality. Funding German Research Foundation;
German Heart Research Foundation; German Cardiac Society;
Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte; University
of Leipzig-Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.

<14>
Accession Number
52757852
Title
Safety and effi cacy of drug-eluting stents in women: A patient-level
pooled analysis of randomised trials.
Source
The Lancet. 382 (9908) (pp 1879-1888), 2013. Date of Publication: 2013.
Author
Stefanini G.G.; Baber U.; Windecker S.; Morice M.-C.; Sartori S.; Leon
M.B.; Stone G.W.; Serruys P.W.; Wijns W.; Weisz G.; Camenzind E.; Steg
P.G.; Smits P.C.; Kandzari D.; Von Birgelen C.; Galatius S.; Jeger R.V.;
Kimura T.; Mikhail G.W.; Itchhaporia D.; Mehta L.; Ortega R.; Kim H.-S.;
Valgimigli M.; Kastrati A.; Chieffo A.; Mehran R.
Institution
(Stefanini, Windecker) Bern University Hospital, Bern, Switzerland
(Baber, Sartori, Mehran) Mount Sinai School of Medicine, New York, NY,
United States
(Leon, Stone, Weisz) Columbia University Medical Center, New York, NY,
United States
(Wijns) Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis
Ziekenhuis, Aalst, Belgium
(Camenzind) University of Geneva, Geneva, Switzerland
(Jeger) University Hospital Basel, Basel, Switzerland
(Steg) Departement Hospitalo- Universitaire Fibrose, Infl Ammation et
REmodelage, Universite Paris- Diderot, Paris, France
(Smits) Maasstad Hospital, Rotterdam, Netherlands
(Von Birgelen) Thoraxcentrum Twente, Enschede, Netherlands
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Galatius) Gentofte University Hospital, Hellerup, Denmark
(Kimura) Kyoto University Graduate School of Medicine, Kyoto, Japan
(Mikhail) Imperial College Healthcare NHS Trust, London, United Kingdom
(Kim) Seoul National University Main Hospital, Seoul, South Korea
(Valgimigli) University of Ferrara, Ferrara, Italy
(Kastrati) Deutsches Herzzentrum, Munich, Germany
(Serruys) Erasmus MC, Rotterdam, Netherlands
(Itchhaporia) Hoag Memorial Hospital Presbyterian, Newport Beach, CA,
United States
(Ortega) Society of Cardiovascular Angiography and Interventions,
Washington, DC, United States
(Mehta) Ohio State University Medical Center, Columbus, OH, United States
(Chieffo) San Raffaele Hospital, Milan, Italy
(Morice) Institut Cardiovasculaire, Paris-Sud, France
Publisher
Elsevier B.V.
Abstract
Background The safety and effi cacy of drug-eluting stents (DES) in the
treatment of coronary artery disease have been assessed in several
randomised trials. However, none of these trials were powered to assess
the safety and effi cacy of DES in women because only a small proportion
of recruited participants were women. We therefore investigated the safety
and effi cacy of DES in female patients during long-term follow-up.
Methods We pooled patient-level data for female participants from 26
randomised trials of DES and analysed outcomes according to stent type
(bare-metal stents, early-generation DES, and newer-generation DES). The
primary safety endpoint was a composite of death or myocardial infarction.
The secondary safety endpoint was defi nite or probable stent thrombosis.
The primary effi cacy endpoint was target-lesion revascularisation.
Analysis was by intention to treat. Findings Of 43 904 patients recruited
in 26 trials of DES, 11 557 (26.3%) were women (mean age 67.1 years [SD
10.6]). 1108 (9.6%) women received bare-metal stents, 4171 (36.1%)
early-generation DES, and 6278 (54.3%) newergeneration DES. At 3 years,
estimated cumulative incidence of the composite of death or myocardial
infarction occurred in 132 (12.8%) women in the bare-metal stent group,
421 (10.9%) in the early-generation DES group, and 496 (9.2%) in the
newer-generation DES group (p=0.001). Defi nite or probable stent
thrombosis occurred in 13 (1.3%), 79 (2.1%), and 66 (1.1%) women in the
bare-metal stent, early-generation DES, and newer-generation DES groups,
respectively (p=0.01). The use of DES was associated with a signifi cant
reduction in the 3 year rates of targetlesion revascularisation (197
[18.6%] women in the bare-metal stent group, 294 [7.8%] in the
early-generation DES group, and 330 [6.3%] in the newer-generation DES
group, p<0.0001). Results did not change after adjustment for baseline
characteristics in the multivariable analysis. Interpretation The use of
DES in women is more effective and safe than is use of bare-metal stents
during longterm follow-up. Newer-generation DES are associated with an
improved safety profi le compared with earlygeneration DES, and should
therefore be thought of as the standard of care for percutaneous coronary
revascularisation in women.

<15>
Accession Number
52700728
Title
Platelet reactivity and clinical outcomes after coronary artery
implantation of drug-eluting stents (ADAPT-DES): A prospective multicentre
registry study.
Source
The Lancet. 382 (9892) (pp 614-623), 2013. Date of Publication: 2013.
Author
Stone G.W.; Witzenbichler B.; Weisz G.; Rinaldi M.J.; Neumann F.-J.;
Metzger D.C.; Henry T.D.; Cox D.A.; Duffy P.L.; Mazzaferri E.; Gurbel
P.A.; Xu K.; Parise H.; Kirtane A.J.; Brodie B.R.; Mehran R.; Stuckey T.D.
Institution
(Stone, Weisz, Xu, Parise, Kirtane) Columbia University Medical Center,
New York-Presbyterian Hospital, Cardiovascular Research Foundation, 111 E
59th Street, New York, NY 10022, United States
(Witzenbichler) Charite Campus Benjamin Franklin, Berlin, Germany
(Rinaldi) Sanger Heart and Vascular Institute, Charlotte, NC, United
States
(Neumann) Universitats-Herzzentrum Freibrug Bad Krozingen, Bad Krozingen,
Germany
(Metzger) Wellmont CVA Heart Institute, Kingsport, TN, United States
(Henry) Minneapolis Heart Institute, Minneapolis, MN, United States
(Cox) Lehigh Valley Health Network, Allentown, PA, United States
(Duffy) FirstHealth Moore Regional Hospital, Pinehurst, NC, United States
(Mazzaferri) Ohio State University, Columbus, OH, United States
(Gurbel) Sinai Hospital of Baltimore, Baltimore, MD, United States
(Brodie, Stuckey) Moses Cone Heart and Vascular Center, Greensboro, NC,
United States
(Mehran) Mount Sinai Medical Center, Cardiovascular Research Foundation,
New York, NY, United States
Publisher
Elsevier B.V.
Abstract
Background The relation between platelet reactivity and stent thrombosis,
major bleeding, and other adverse events after coronary artery
implantation of drug-eluting stents has been incompletely characterised.
We aimed to determine the relation between platelet reactivity during dual
therapy with aspirin and clopidogrel and clinical outcomes after
successful coronary drug-eluting stent implantation. Methods ADAPT-DES was
a prospective, multicentre registry of patients successfully treated with
one or more drugeluting stents and given aspirin and clopidogrel at 10-15
US and European hospitals. We assessed platelet reactivity in those
patients after successful percutaneous coronary intervention using
VerifyNow point-of-care assays, and assigned different cutoffs to define
high platelet reactivity. The primary endpoint was definite or probable
stent thrombosis; other endpoints were all-cause mortality, myocardial
infarction, and clinically relevant bleeding. We did a propensity-adjusted
multivariable analysis to determine the relation between platelet
reactivity and subsequent adverse events. This study is registered with
ClinicalTrials.gov, number NCT00638794. Findings Between Jan 7, 2008, and
Sept 16, 2010, 8665 patients were prospectively enrolled at 11 sites, of
which 8583 were eligible. At 1-year follow-up, stent thrombosis had
occurred in 70 (0.8%) patients, myocardial infarction in 269 (3.1%),
clinically relevant bleeding in 531 (6.2%), and death in 161 (1.9%)
patients. High platelet reactivity on clopidogrel was strongly related to
stent thrombosis (adjusted HR 2.49 [95% CI 1.43-4.31], p=0.001) and
myocardial infarction (adjusted HR 1.42 [1.09-1.86], p=0.01), was
inversely related to bleeding (adjusted HR 0.73 [0.61- 0.89], p=0.002),
but was not related to mortality (adjusted HR 1.20 [0.85-1.70], p=0.30).
High platelet reactivity on aspirin was not significantly associated with
stent thrombosis (adjusted HR 1.46 [0.58-3.64], p=0.42), myocardial
infarction, or death, but was inversely related to bleeding (adjusted HR
0.65 [0.43-0.99], p=0.04). Interpretation The findings from this study
emphasise the counter-balancing effects of haemorrhagic and ischaemic
complications after stent implantation, and suggest that safer drugs or
tailored strategies for the use of more potent agents must be developed if
the benefits of greater platelet inhibition in patients with
cardiovascular disease are to be realised.

<16>
Accession Number
52418276
Title
Abluminal biodegradable polymer biolimus-eluting stent versus durable
polymer everolimus-eluting stent (COMPARE II): A randomised, controlled,
non-inferiority trial.
Source
The Lancet. 381 (9867) (pp 651-660), 2013. Date of Publication: February
2013.
Author
Smits P.C.; Hofma S.; Togni M.; Vazquez N.; Valdes M.; Voudris V.;
Slagboom T.; Goy J.-J.; Vuillomenet A.; Serra A.; Nouche R.T.; Den Heijer
P.; Van Der Ent M.
Institution
(Smits, Van Der Ent) Department of Cardiology, Maasstad Ziekenhuis,
Maasstadweg 21, 3079 DZ Rotterdam, Netherlands
(Hofma) Department of Cardiology, Medisch Centrum Leeuwarden, Leeuwarden,
Netherlands
(Togni, Goy) Department of Cardiology, HOpital Cantonal de Fribourg,
Fribourg, Switzerland
(Vazquez) Department of Cardiology, Hospitalario Juan Canalejo, Coruna,
Spain
(Valdes) Department of Cardiology, Hospital Virgen Arrixaca, Murcia, Spain
(Voudris) Department of Cardiology, Onassis Cardiac Surgery Centre,
Athens, Greece
(Slagboom) Department of Cardiology, Onze Lieve Vrouwe Gasthuis,
Amsterdam, Netherlands
(Vuillomenet) Department of Cardiology, Kantonsspital Aarau, Aarau,
Switzerland
(Serra) Department of Cardiology, Hospital Del Mar, Barcelona, Spain
(Serra) Department of Cardiology, Hospital Sant Pau, Barcelona, Spain
(Nouche) Department of Cardiology, Hospital de Santiago de Compostela,
Santiagio de Compostela, Spain
(Den Heijer) Department of Cardiology, Amphia Ziekenhuis, Breda,
Netherlands
Publisher
Elsevier B.V.
Abstract
Background Drug-eluting stents with durable biocompatible or biodegradable
polymers have been developed to address the risk of thrombosis associated
with first-generation drug-eluting stents. We aimed to compare the safety
and efficacy of a biodegradable polymer-coated biolimus-eluting stent with
a thin-strut everolimus-eluting stent coated with a durable biocompatible
polymer. Methods This open-label, prospective, randomised, controlled,
non-inferiority trial was undertaken at 12 sites across Europe. We used
limited exclusion criteria (age p>18 years, life expectancy p>5 years,
reference vessel diameter 2*0-4*0 mm) to enrol patients eligible for
percutaneous coronary intervention. Patients were randomly allocated (2:1)
by computer-generated random numbers to receive either a biodegradable
polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable
fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott
Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA,
USA). The primary endpoint was a composite of safety (cardiac death and
non-fatal myocardial infarction) and efficacy (clinically indicated target
vessel revascularisation) at 12 months, analysed by intention to treat.
Patients received dual antiplatelet therapy for 12 months after discharge.
The trial is registered with ClinicalTrials.gov, number NCT01233453.
Findings From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients
(4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting
stent (2638 lesions) and 912 to an everolimus-eluting stent (1387
lesions). 2688 (99*3%) patients completed 12 months' follow-up.
Significantly more patients in the biolimus-eluting stent group received a
non-assigned stent than did those in the everolimus-eluting stent group
(105 [5*9%] vs 19 [2*1%]; p<0*0001). The primary endpoint occurred in 93
(5*2%) patients in the biolimus-eluting stent group and 44 (4*8%) patients
in the everolimus-eluting stent group at 12 months (relative risk 1*07
[95% CI 0*75-1*52]; p <inf>non-inferiorityp</inf><0*0001). Analysis per
protocol did not change the outcome of this trial
(p<inf>non-inferiorityp</inf><0*0001). Interpretation Biodegradable
polymer biolimus-eluting stents are as safe and efficacious as the current
standard of a thin-strut everolimus-eluting stent with a durable
biocompatible polymer. We need to follow-up patients for longer to show
whether the biolimus-eluting stent reduces the risk of stent thrombosis
after 1 year when compared with the everolimus-eluting stent. Funding
Terumo Europe (Leuven, Belgium) and the Research Foundation of the
Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).

<17>
Accession Number
52015679
Title
The effects of lowering LDL cholesterol with statin therapy in people at
low risk of vascular disease: Meta-analysis of individual data from 27
randomised trials.
Source
The Lancet. 380 (9841) (pp 581-590), 2012. Date of Publication: 01 Aug
2012.
Author
Mihaylova B.; Emberson J.; Blackwell L.; Keech A.; Simes J.; Barnes E.H.;
Voysey M.; Gray A.; Collins R.; Baigent C.; De Lemos J.; Braunwald E.;
Blazing M.; Murphy S.; Downs J.R.; Gotto A.; Clearfield M.; Holdaas H.;
Gordon D.; Davis B.; Koren M.; Dahlof B.; Poulter N.; Sever P.; Knopp
R.H.; Fellstrom B.; Jardine A.; Schmieder R.; Zannad F.; Goldbourt U.;
Kaplinsky E.; Colhoun H.M.; Betteridge D.J.; Durrington P.N.; Hitman G.A.;
Fuller J.; Neil A.; Wanner C.; Krane V.; Sacks F.; Moye L.; Pfeffer M.;
Hawkins C.M.; Kjekshus J.; Wedel H.; Wikstrand J.; Barter P.; Tavazzi L.;
Maggioni A.; Marchioli R.; Tognoni G.; Franzosi M.G.; Bloomfield H.;
Robins S.; Armitage J.; Parish S.; Peto R.; Sleight P.; Pedersen T.R.;
Ridker P.M.; Holman R.; Meade T.; MacMahon S.; Marschner I.; Tonkin A.;
Shaw J.; Serruys P.W.; Nakamura H.; Knatterud G.; Furberg C.; Byington R.;
MacFarlane P.; Cobbe S.; Ford I.; Murphy M.; Blauw G.J.; Packard C.;
Shepherd J.; Wilhelmsen L.; Cannon C.; Bowman L.; Landray M.; La Rosa J.;
Rossouw J.; Probstfi Eld J.; Flather M.; Kastelein J.; Newman C.; Shear
C.; Tobert J.; Varigos J.; White H.; Yusuf S.; Mellies M.; McGovern M.;
Barclay J.; Belder R.; Mitchel M.Y.; Musliner T.; Ansquer J.-C.; Llewellyn
B.M.; Pharma N.; Bortolini M.; Brandrup-Wognsen G.; Bryzinski B.; Olsson
G.; Pears J.; DeMicco D.; Baxter A.; Bhala N.; Buck G.; Herrington W.G.;
Holland L.E.; Kearney P.M.; Kirby A.; Lewis D.A.; Pollicino C.; Reith C.;
Sourjina T.
Institution
(Baigent, Marschner, Baxter, Bhala, Buck, Herrington, Holland, Kearney,
Kirby, Lewis, Pollicino, Reith, Sourjina) National Health and Medical
Research Council (NHMRC), Clinical Trial Centre, University of Sydney,
Mallett Street Campus M02, NSW 2006, Australia
Publisher
Elsevier B.V. (E-mail: cususerv@lancet.com)
Abstract
Background Statins reduce LDL cholesterol and prevent vascular events, but
their net effects in people at low risk of vascular events remain
uncertain. Methods This meta-analysis included individual participant data
from 22 trials of statin versus control (n=134 537; mean LDL cholesterol
difference 1.08 mmol/L; median follow-up 4.8 years) and five trials of
more versus less statin (n=39 612; difference 0.51 mmol/L; 5.1 years).
Major vascular events were major coronary events (ie, non-fatal myocardial
infarction or coronary death), strokes, or coronary revascularisations.
Participants were separated into five categories of baseline 5-year major
vascular event risk on control therapy (no statin or low-intensity statin)
(<5%, >=5% to <10%, >=10% to <20%, >=20% to <30%, >=30%); in each, the
rate ratio (RR) per 1.0 mmol/L LDL cholesterol reduction was estimated.
Findings Reduction of LDL cholesterol with a statin reduced the risk of
major vascular events (RR 0.79, 95% CI 0.77-0.81, per 1.0 mmol/L
reduction), largely irrespective of age, sex, baseline LDL cholesterol or
previous vascular disease, and of vascular and all-cause mortality. The
proportional reduction in major vascular events was at least as big in the
two lowest risk categories as in the higher risk categories (RR per 1.0
mmol/L reduction from lowest to highest risk: 0.62 [99% CI 0.47-0.81],
0.69 [99% CI 0.60-0.79], 0.79 [99% CI 0.74-0.85], 0.81 [99% CI 0.77-0.86],
and 0.79 [99% CI 0.74-0.84]; trend p=0.04), which reflected significant
reductions in these two lowest risk categories in major coronary events
(RR 0.57, 99% CI 0.36-0.89, p=0.0012, and 0.61, 99% CI 0.50-0.74,
p<0.0001) and in coronary revascularisations (RR 0.52, 99% CI 0.35-0.75,
and 0.63, 99% CI 0.51-0.79; both p<0.0001). For stroke, the reduction in
risk in participants with 5-year risk of major vascular events lower than
10% (RR per 1.0 mmol/L LDL cholesterol reduction 0.76, 99% CI 0.61-0.95,
p=0.0012) was also similar to that seen in higher risk categories (trend
p=0.3). In participants without a history of vascular disease, statins
reduced the risks of vascular (RR per 1.0 mmol/L LDL cholesterol reduction
0.85, 95% CI 0.77-0.95) and all-cause mortality (RR 0.91, 95% CI
0.85-0.97), and the proportional reductions were similar by baseline risk.
There was no evidence that reduction of LDL cholesterol with a statin
increased cancer incidence (RR per 1.0 mmol/L LDL cholesterol reduction
1.00, 95% CI 0.96-1.04), cancer mortality (RR 0.99, 95% CI 0.93-1.06), or
other non-vascular mortality. Interpretation In individuals with 5-year
risk of major vascular events lower than 10%, each 1 mmol/L reduction in
LDL cholesterol produced an absolute reduction in major vascular events of
about 11 per 1000 over 5 years. This benefi t greatly exceeds any known
hazards of statin therapy. Under present guidelines, such individuals
would not typically be regarded as suitable for LDL-lowering statin
therapy. The present report suggests, therefore, that these guidelines
might need to be reconsidered.

<18>
Accession Number
51745793
Title
Self-monitoring of oral anticoagulation: Systematic review and
meta-analysis of individual patient data.
Source
The Lancet. 379 (9813) (pp 322-334), 2012. Date of Publication: January
28-February 3, 2012.
Author
Heneghan C.; Ward A.; Perera R.
Institution
(Heneghan, Ward, Perera) Oxford University, Department of Primary Care
Health Sciences, 23-38 Hythe Bridge St, Oxford, OX1 2ET, United Kingdom
Publisher
Elsevier B.V.
Abstract
Background: Uptake of self-testing and self-management of oral coagulation
has remained inconsistent, despite good evidence of their effectiveness.
To clarify the value of self-monitoring of oral anticoagulation, we did a
meta-analysis of individual patient data addressing several important gaps
in the evidence, including an estimate of the effect on time to death,
first major haemorrhage, and thromboembolism. <br/>Method(s): We searched
Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting
searches to randomised trials with a maximally sensitive strategy. We
approached all authors of included trials and requested individual patient
data: primary outcomes were time to death, first major haemorrhage, and
first thromboembolic event. We did prespecified subgroup analyses
according to age, type of control-group care (anticoagulation-clinic care
vs primary care), self-testing alone versus self-management, and sex. We
analysed patients with mechanical heart valves or atrial fibrillation
separately. We used a random-effect model method to calculate pooled
hazard ratios and did tests for interaction and heterogeneity, and
calculated a time-specific number needed to treat. <br/>Finding(s): Of
1357 abstracts, we included 11 trials with data for 6417 participants and
12 800 person-years of follow-up. We reported a significant reduction in
thromboembolic events in the self-monitoring group (hazard ratio 0.51; 95
CI 0.31-0.85) but not for major haemorrhagic events (0.88, 0.74-1.06) or
death (0.82, 0.62-1.09). Participants younger than 55 years showed a
striking reduction in thrombotic events (hazard ratio 0.33, 95 CI
0.17-0.66), as did participants with mechanical heart valve (0.52,
0.35-0.77). Analysis of major outcomes in the very elderly (age >=85
years, n=99) showed no significant adverse effects of the intervention for
all outcomes. <br/>Interpretation(s): Our analysis showed that
self-monitoring and self-management of oral coagulation is a safe option
for suitable patients of all ages. Patients should also be offered the
option to self-manage their disease with suitable health-care support as
back-up. <br/>Funding(s): UK National Institute for Health Research (NIHR)
Technology Assessment Programme, UK NIHR National School for Primary Care
Research. &#xa9; 2012 Elsevier Ltd.

<19>
Accession Number
51470138
Title
Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin
monotherapy and paclitaxel-eluting stents versus bare-metal stents in
acute myocardial infarction (HORIZONS-AMI): Final 3-year results from a
multicentre, randomised controlled trial.
Source
The Lancet. 377 (9784) (pp 2193-2204), 2011. Date of Publication: June
25-July 1, 2011.
Author
Stone G.W.; Witzenbichler B.; Guagliumi G.; Peruga J.Z.; Brodie B.R.;
Dudek D.; Kornowski R.; Hartmann F.; Gersh B.J.; Pocock S.J.; Dangas G.;
Wong S.C.; Fahy M.; Parise H.; Mehran R.
Institution
(Stone, Fahy, Parise) New York-Presbyterian Hospital, Columbia University,
Medical Center and the Cardiovascular Research Foundation, New York, NY,
United States
(Witzenbichler) Charite Campus Benjamin Franklin, Berlin, Germany
(Guagliumi) Ospedali Riuniti di Bergamo, Bergamo, Italy
(Peruga) Silesian Centre for Heart Disease, Lodz, Poland
(Brodie) LeBauer Cardiovascular Research Foundation and Moses Cone
Hospital, Greensboro, NC, United States
(Dudek) Jagiellonian University, Krakow, Poland
(Kornowski) Rabin Medical Centre, Petach Tikva, Israel
(Hartmann) Universitatsklinikum Schleswig-Holstein, Lubeck, Germany
(Gersh) Mayo Clinic, Rochester, MN, United States
(Pocock) London School of Hygiene and Tropical Medicine, London, United
Kingdom
(Dangas, Mehran) Mount Sinai Medical Center, Cardiovascular Research
Foundation, New York, NY, United States
(Wong) New York-Presbyterian Hospital, Weill Cornell Medical Center, New
York, NY, United States
(Stone) Columbia University Medical Center, Cardiovascular Research
Foundation, 111 East 59th Street, New York, NY 10022, United States
Publisher
Elsevier B.V.
Abstract
Primary results of the HORIZONS-AMI trial have been previously reported.
In this final report, we aimed to assess 3-year outcomes. HORIZONS-AMI was
a prospective, open-label, randomised trial undertaken at 123 institutions
in 11 countries. Patients aged 18 years or older were eligible for
enrolment if they had ST-segment elevation myocardial infarction (STEMI),
presented within 12 h after onset of symptoms, and were undergoing primary
percutaneous coronary intervention. By use of a computerised interactive
voice response system, we randomly allocated patients 1:1 to receive
bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI;
pharmacological randomisation; stratified by previous and expected drug
use and study site) and, if eligible, randomly allocated 3:1 to receive a
paclitaxel-eluting stent or a bare metal stent (stent randomisation;
stratified by pharmacological group assignment, diabetes mellitus status,
lesion length, and study site). We produced Kaplan-Meier estimates of
major adverse cardiovascular events at 3 years by intention to treat. This
study is registered with ClinicalTrials.gov, number NCT00433966. Compared
with 1802 patients allocated to receive heparin plus a GPI, 1800 patients
allocated to bivalirudin monotherapy had lower rates of all-cause
mortality (5.9 vs 7.7, difference -1.9 [-3.5 to -0.2], HR 0.75
[0.58-0.97]; p=0.03), cardiac mortality (2.9 vs 5.1, -2.2 [-3.5 to -0.9],
0.56 [0.40-0.80]; p=0.001), reinfarction (6.2 vs 8.2, -1.9 [-3.7 to -0.2],
0.76 [0.59-0.99]; p=0.04), and major bleeding not related to bypass graft
surgery (6.9 vs 10.5, -3.6 [-5.5 to -1.7], 0.64 [0.51-0.80]; p=0.0001) at
3 years, with no significant differences in ischaemia-driven target vessel
revascularisation, stent thrombosis, or composite adverse events. Compared
with 749 patients who received a bare-metal stent, 2257 patients who
received a paclitaxel-eluting stent had lower rates of ischaemia-driven
target lesion revascularisation (9.4 vs 15.1, -5.7 [-8.6 to -2.7], 0.60
[0.48-0.76]; p<0.0001) after 3 years, with no significant differences in
the rates of death, reinfarction, stroke or stent thrombosis. Stent
thrombosis was high (>=4.5) in both groups. The effectiveness and safety
of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained
at 3 years for patients with STEMI undergoing primary percutaneous
coronary intervention. Boston Scientific and The Medicines Company. &#xa9;
2011 Elsevier Ltd.

<20>
Accession Number
51464994
Title
The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in
patients with chronic kidney disease (Study of Heart and Renal
Protection): A randomised placebo-controlled trial.
Source
The Lancet. 377 (9784) (pp 2181-2192), 2011. Date of Publication: June
25-July 1, 2011.
Author
Baigent C.; Landray M.J.; Reith C.; Emberson J.; Wheeler D.C.; Tomson C.;
Wanner C.; Krane V.; Cass A.; Craig J.; Neal B.; Jiang L.; Hooi L.S.;
Levin A.; Agodoa L.; Gaziano M.; Kasiske B.; Walker R.; Massy Z.A.;
Feldt-Rasmussen B.; Krairittichai U.; Ophascharoensuk V.; Fellstrom B.;
Holdaas H.; Tesar V.; Wiecek A.; Grobbee D.; De Zeeuw D.; Gronhagen-Riska
C.; Dasgupta T.; Lewis D.; Herrington W.; Mafham M.; Majoni W.;
Wallendszus K.; Grimm R.; Pedersen T.; Tobert J.; Armitage J.; Baxter A.;
Bray C.; Chen Y.; Chen Z.; Hill M.; Knott C.; Parish S.; Simpson D.;
Sleight P.; Young A.; Collins R.
Institution
(Baigent, Landray, Reith, Emberson, Lewis, Herrington, Mafham,
Wallendszus, Armitage, Baxter, Bray, Chen, Chen, Hill, Knott, Parish,
Simpson, Young, Collins) Clinical Trial Service Unit, Epidemiological
Studies Unit, University of Oxford, Oxford, United Kingdom
(Wheeler) University College London, London, United Kingdom
(Tomson) North Bristol NHS Trust, Bristol, United Kingdom
(Wanner, Krane) Department of Medicine 1, Division of Nephrology,
University of Wuerzburg, Wuerzburg, Germany
(Cass, Neal) George Institute for Global Health, University of Sydney,
Sydney, NSW, Australia
(Craig) Sydney School of Public Health, Children's Hospital at Westmead,
University of Sydney, Sydney, NSW, Australia
(Jiang) China Oxford Centre for International Health Research, Fuwai
Hospital, Beijing, Chinese Academy of Medical Sciences, China
(Hooi) Department of Medicine, Haemodialysis Unit, Sultanah Aminah
Hospital, Johor Bahru, Malaysia
(Levin) University of British Columbia, Vancouver, BC, Canada
(Agodoa) National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health, Bethesda, MD, United States
(Gaziano) Harvard Medical School, VA Boston, Brigham and Women's Hospital,
Boston, MA, United States
(Kasiske) University of Minnesota, Minneapolis, MN, United States
(Walker) Dunedin School of Medicine, University of Otago, Otago, New
Zealand
(Massy) Division of Clinical Pharmacology, Amiens University Hospital,
University of Picardie Jules Verne, Amiens, France
(Feldt-Rasmussen) Rigshospitalet, University of Copenhagen, Copenhagen,
Denmark
(Krairittichai) Division of Nephrology, Department of Medicine, Rajavithi
Hospital, Bangkok, Thailand
(Ophascharoensuk) Department of Internal Medicine, Faculty of Medicine,
Chiang Mai University, Chiang Mai, Thailand
(Fellstrom) University Hospital, Uppsala, Sweden
(Holdaas) Department of Organ Transplantation, Oslo University Hospital,
Rikshospitalet, Oslo, Norway
(Tesar) Department of Nephrology, General University Hospital, Charles
University, Prague, Czechia
(Wiecek) Department of Nephrology, Endocrinology and Metabolic Diseases,
Medical University of Silesia, Katowice, Poland
(Grobbee) Julius Center for Health Sciences and Primary Care, University
Medical Center Utrecht, Utrecht, Netherlands
(De Zeeuw) Department of Clinical Pharmacology, University Medical Center
Groningen, Groningen, Netherlands
(Gronhagen-Riska) Helsinki University Hospital, Helsinki, Finland
(Dasgupta) Oxford Radcliffe Hospitals NHS Trust, Oxford, United Kingdom
(Majoni) Royal Darwin Hospital, Darwin, NT, Australia
(Grimm) Berman Center for Outcomes and Clinical Research, Hennepin County
Medical Center, University of Minnesota, Minneapolis, MN, United States
(Pedersen) University of Oslo, Centre of Preventive Medicine, Oslo
University Hospital Ullevl, Oslo, Norway
(Tobert) Tobert Medical Consulting LLC, Warren, NJ, United States
(Sleight) Nuffield Department of Clinical Medicine, John Radcliffe
Hospital, Oxford, United Kingdom
(Baigent) Clinical Trial Service Unit, Epidemiological Studies Unit
(CTSU), Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford
OX3 7LF, United Kingdom
Publisher
Elsevier B.V.
Abstract
Lowering LDL cholesterol with statin regimens reduces the risk of
myocardial infarction, ischaemic stroke, and the need for coronary
revascularisation in people without kidney disease, but its effects in
people with moderate-to-severe kidney disease are uncertain. The SHARP
trial aimed to assess the efficacy and safety of the combination of
simvastatin plus ezetimibe in such patients. This randomised double-blind
trial included 9270 patients with chronic kidney disease (3023 on dialysis
and 6247 not) with no known history of myocardial infarction or coronary
revascularisation. Patients were randomly assigned to simvastatin 20 mg
plus ezetimibe 10 mg daily versus matching placebo. The key prespecified
outcome was first major atherosclerotic event (non-fatal myocardial
infarction or coronary death, non-haemorrhagic stroke, or any arterial
revascularisation procedure). All analyses were by intention to treat.
This trial is registered at ClinicalTrials.gov, NCT00125593, and
ISRCTN54137607. 4650 patients were assigned to receive simvastatin plus
ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe
yielded an average LDL cholesterol difference of 0.85 mmol/L (SE 0.02;
with about two-thirds compliance) during a median follow-up of 4.9 years
and produced a 17 proportional reduction in major atherosclerotic events
(526 [11.3] simvastatin plus ezetimibe vs 619 [13.4] placebo; rate ratio
[RR] 0.83, 95 CI 0.74-0.94; log-rank p=0.0021). Non-significantly fewer
patients allocated to simvastatin plus ezetimibe had a non-fatal
myocardial infarction or died from coronary heart disease (213 [4.6] vs
230 [5.0]; RR 0.92, 95 CI 0.76-1.11; p=0.37) and there were significant
reductions in non-haemorrhagic stroke (131 [2.8] vs 174 [3.8]; RR 0.75, 95
CI 0.60-0.94; p=0.01) and arterial revascularisation procedures (284 [6.1]
vs 352 [7.6]; RR 0.79, 95 CI 0.68-0.93; p=0.0036). After weighting for
subgroup-specific reductions in LDL cholesterol, there was no good
evidence that the proportional effects on major atherosclerotic events
differed from the summary rate ratio in any subgroup examined, and, in
particular, they were similar in patients on dialysis and those who were
not. The excess risk of myopathy was only two per 10 000 patients per year
of treatment with this combination (9 [0.2] vs 5 [0.1]). There was no
evidence of excess risks of hepatitis (21 [0.5] vs 18 [0.4]), gallstones
(106 [2.3] vs 106 [2.3]), or cancer (438 [9.4] vs 439 [9.5], p=0.89) and
there was no significant excess of death from any non-vascular cause (668
[14.4] vs 612 [13.2], p=0.13). Reduction of LDL cholesterol with
simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence
of major atherosclerotic events in a wide range of patients with advanced
chronic kidney disease. Merck/Schering-Plough Pharmaceuticals; Australian
National Health and Medical Research Council; British Heart Foundation; UK
Medical Research Council. &#xa9; 2011 Elsevier Ltd.

<21>
Accession Number
51345649
Title
Unrestricted randomised use of two new generation drug-eluting coronary
stents: 2-year patient-related versus stent-related outcomes from the
RESOLUTE All Comers trial.
Source
The Lancet. 377 (9773) (pp 1241-1247), 2011. Date of Publication: April
9-15, 2011.
Author
Silber S.; Windecker S.; Vranckx P.; Serruys P.W.
Institution
(Silber) Heart Centre at the Isar, Am Isarkanal 36, D-81379 Munich,
Germany
(Windecker) Bern University Hospital, Bern, Switzerland
(Serruys) Department of Interventional Cardiology, Thoraxcentre,
University Medical Centre Rotterdam, Rotterdam, Netherlands
(Vranckx) Department of Cardiology and Critical Care Medicine, Hartcentrum
Hasselt, Hasselt, Belgium
Publisher
Elsevier B.V.
Abstract
In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent
was non-inferior to the Xience V everolimus-eluting stent for the primary
stent-related endpoint of target lesion failure (cardiac death, target
vessel myocardial infarction, and ischaemia-driven target lesion
revascularisation) at 1 year. However, data for long-term safety and
efficacy from randomised studies of new generation drug-eluting coronary
stents in patients treated in routine clinical practice are scarce. We
report the prespecified 2-year clinical outcomes from the RESOLUTE All
Comers trial. In 2008, patients with at least one coronary lesion 2.25-4.0
mm in diameter, with greater than 50 stenosis, were randomly assigned to a
Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent
at 17 centres in Europe and Israel. Randomisation was by an interactive
voice response system stratified by centre. Study investigators were not
masked to treatment allocation; but those who did data management and
analysis, and patients were masked. There were no restrictions as to the
number of vessels or lesions treated, or the number of stents implanted.
We assessed prespecified safety and efficacy outcomes at 2 years with
specific focus on patient-related composite (all death, all myocardial
infarction, all revascularisation) and stent-related composite outcomes.
Analyses were by intention to treat. This study is registered with
ClinicalTrials.gov, number NCT00617084. 1140 patients were assigned to the
zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121
and 1128 patients, respectively, completed 2-year follow-up. The
patient-related outcome (231 [20.6] zotarolimus vs 231 [20.5] everolimus;
difference 0.1, 95 CI -3.2 to 3.5; p=0.958) and stent-related outcome (126
[11.2] vs 121 [10.7]; difference 0.5, -2.1 to 3.1; p=0.736) did not differ
between groups, although rates of the stent-related outcome were
substantially lower than were those for the patient-related outcome. Three
patients in each group (0.3) had very late (after 1 year) stent
thrombosis. Similar safety and efficacy outcomes were sustained between
two new generation drug-eluting stents at 2-year follow-up. The greater
number of patient-related than stent-related events in patients with
complex clinical and lesion characteristics emphasises that during
long-term follow-up, the optimisation of secondary prevention is at least
as important as the selection of which new generation drug-eluting stent
to implant in a specific lesion. Medtronic (USA). &#xa9; 2011 Elsevier
Ltd.

<22>
Accession Number
51715356
Title
Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO):
Initial results of a randomised phase 1 trial.
Source
The Lancet. 378 (9806) (pp 1847-1857), 2011. Date of Publication: November
26-December 2, 2011.
Author
Bolli R.; Chugh A.R.; D'Amario D.; Loughran J.H.; Stoddard M.F.; Ikram S.;
Beache G.M.; Wagner S.G.; Leri A.; Hosoda T.; Sanada F.; Elmore J.B.;
Goichberg P.; Cappetta D.; Solankhi N.K.; Fahsah I.; Rokosh D.G.;
Slaughter M.S.; Kajstura J.; Anversa P.
Institution
(Bolli, Chugh, Loughran, Stoddard, Ikram, Wagner, Elmore, Solankhi,
Fahsah, Rokosh) Division of Cardiovascular Medicine, University of
Louisville, Ambulatory Care Building, 550 S Jackson Street, Louisville, KY
40202, United States
(Slaughter) Cardiothoracic Surgery, University of Louisville, Louisville,
KY, United States
(Beache) Department of Radiology, University of Louisville, Louisville,
KY, United States
(D'Amario, Leri, Hosoda, Sanada, Goichberg, Cappetta, Kajstura, Anversa)
Department of Anesthesia and Medicine, Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, United States
Publisher
Elsevier B.V.
Abstract
c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve
post-infarction left ventricular (LV) dysfunction when administered to
animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with
Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of
heart failure resulting from ischaemic heart disease. In stage A of the
SCIPIO trial, patients with post-infarction LV dysfunction (ejection
fraction [EF] <=40) before coronary artery bypass grafting were
consecutively enrolled in the treatment and control groups. In stage B,
patients were randomly assigned to the treatment or control group in a 2:3
ratio by use of a computer-generated block randomisation scheme. 1 million
autologous CSCs were administered by intracoronary infusion at a mean of
113 days (SE 4) after surgery; controls were not given any treatment.
Although the study was open label, the echocardiographic analyses were
masked to group assignment. The primary endpoint was short-term safety of
CSCs and the secondary endpoint was efficacy. A per-protocol analysis was
used. This study is registered with ClinicalTrials.gov, number
NCT00474461. This study is still in progress. 16 patients were assigned to
the treatment group and seven to the control group; no CSC-related adverse
effects were reported. In 14 CSC-treated patients who were analysed, LVEF
increased from 30.3 (SE 1.9) before CSC infusion to 38.5 (2.8) at 4 months
after infusion (p=0.001). By contrast, in seven control patients, during
the corresponding time interval, LVEF did not change (30.1 [2.4] at 4
months after CABG vs 30.2 [2.5] at 8 months after CABG). Importantly, the
salubrious effects of CSCs were even more pronounced at 1 year in eight
patients (eg, LVEF increased by 12.3 ejection fraction units [2.1] vs
baseline, p=0.0007). In the seven treated patients in whom cardiac MRI
could be done, infarct size decreased from 32.6 g (6.3) by 7.8 g (1.7; 24)
at 4 months (p=0.004) and 9.8 g (3.5; 30) at 1 year (p=0.04). These
initial results in patients are very encouraging. They suggest that
intracoronary infusion of autologous CSCs is effective in improving LV
systolic function and reducing infarct size in patients with heart failure
after myocardial infarction, and warrant further, larger, phase 2 studies.
University of Louisville Research Foundation and National Institutes of
Health. &#xa9; 2011 Elsevier Ltd.

<23>
Accession Number
51592089
Title
Drug-eluting versus bare-metal stents in saphenous vein graft lesions
(ISAR-CABG): A randomised controlled superiority trial.
Source
The Lancet. 378 (9796) (pp 1071-1078), 2011. Date of Publication: 17 Sep
2011.
Author
Mehilli J.; Pache J.; Abdel-Wahab M.; Schulz S.; Byrne R.A.; Tiroch K.;
Hausleiter J.; Seyfarth M.; Ott I.; Ibrahim T.; Fusaro M.; Laugwitz K.-L.;
Massberg S.; Neumann F.-J.; Richardt G.; Schomig A.; Kastrati A.
Institution
(Mehilli, Pache, Schulz, Byrne, Hausleiter, Ott, Fusaro, Massberg,
Schomig, Kastrati) Deutsches Herzzentrum, Technische Universitat, 80636
Munich, Germany
(Ibrahim, Laugwitz, Schomig) 1 Medizinische Klinik, Klinikum Rechts der
Isar, Technische Universitat, Munich, Germany
(Tiroch, Seyfarth) Medizinische Klinik 3, Helios Kliniken Wuppertal,
Wuppertal, Germany
(Abdel-Wahab, Richardt) Herzzentrum der Segeberger Kliniken, Bad Segeberg,
Germany
(Neumann) Herz-Zentrum, Bad Krozingen, Germany
Publisher
Elsevier B.V.
Abstract
Background Comparative assessment of clinical outcomes after use of
drug-eluting stents versus bare-metal stents for treatment of
aortocoronary saphenous vein graft lesions has not been undertaken in
large randomised trials. We aimed to undertake a comparison in a
randomised trial powered for clinical endpoints. Methods In this
randomised superiority trial, patients with de-novo saphenous vein graft
lesions were assigned by computer-generated sequence (1:1:1:3) to receive
either drug-eluting stents (one of three types: permanent-polymer
paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or
biodegradable-polymer sirolimus-eluting stents) or bare-metal stents.
Randomisation took place immediately after crossing of the lesion with a
guidewire, and was stratifi ed for each participating centre.
Investigators assessing data were masked to treatment allocation; patients
were not masked to allocation. The primary endpoint was the combined
incidence of death, myocardial infarction, and target lesion
revascularisation at 1 year. Analysis was by intention to treat. This
trial is registered at ClinicalTrials.gov, number NCT00611910. Findings
610 patients were allocated to treatment groups (303 drug-eluting stent,
307 bare-metal stent). Drug-eluting stents reduced the incidence of the
primary endpoint compared with bare-metal stents (44 [15%] vs 66 [22%]
patients; hazard ratio [HR] 0*64, 95% CI 0*44-0*94; p=0*02). Target lesion
revascularisation rate was reduced by drug-eluting stents (19 [7%] vs 37
[13%] patients; HR 0*49, 95% CI 0*28-0*86; p=0*01). No signifi cant diff
erences were seen between drug-eluting stents and bare-metal stents
regarding all-cause mortality (15 [5%] vs 14 [5%] patients; HR 1*08, 95%
CI 0*52-2*24; p=0*83), myocardial infarction (12 [4%] vs 18 [6%]; HR 0*66,
95% CI 0*32-1*37; p=0*27), or defi nite or probable stent thrombosis (2
[1%] in both groups; HR 1*00, 95% CI 0*14-7*10; p=0*99). Interpretation In
patients undergoing percutaneous coronary intervention for de-novo
saphenous vein graft lesions, drug-eluting stents are the preferred
treatment option because they reduce the risk of adverse events compared
with bare-metal stents. Funding Deutsches Herzzentrum. &#xa9; 2011
Elsevier Ltd.

<24>
Accession Number
51141585
Title
Efficacy and safety of more intensive lowering of LDL cholesterol: A
meta-analysis of data from 170 000 participants in 26 randomised trials.
Source
The Lancet. 376 (9753) (pp 1670-1681), 2010. Date of Publication: 13 Nov
2010.
Author
Baigent C.; Blackwell L.; Emberson J.; Holland L.E.; Reith C.; Bhala N.;
Peto R.; Barnes E.H.; Keech A.; Simes J.; Collins R.; De Lemos J.;
Braunwald E.; Blazing M.; Murphy S.; Downs J.R.; Gotto A.; Clearfield M.;
Holdaas H.; Gordon D.; Davis B.; Koren M.; Dahlof B.; Poulter N.; Sever
P.; Knopp R.H.; Fellstrom B.; Jardine A.; Schmieder R.; Zannad F.;
Goldbourt U.; Kaplinsky E.; Colhoun H.M.; Betteridge D.J.; Durrington
P.N.; Hitman G.A.; Fuller J.; Neil A.; Wanner C.; Krane V.; Sacks F.; Moye
L.; Pfeffer M.; Hawkins C.M.; Barter P.; Tavazzi L.; Maggioni A.;
Marchioli R.; Tognoni G.; Franzosi M.G.; Bloomfield H.; Robins S.;
Armitage J.; Parish S.; Sleight P.; Pedersen T.R.; Ridker P.M.; Holman R.;
Meade T.; MacMahon S.; Marschner I.; Tonkin A.; Shaw J.; Serruys P.W.;
Nakamura H.; Knatterud G.; Furberg C.; Byington R.; Macfarlane P.; Cobbe
S.; Ford I.; Murphy M.; Blauw G.J.; Packard C.; Shepherd J.; Kjekshus J.;
Wilhelmsen L.; Cannon C.; Bowman L.; Baxter A.; Landray M.; La Rosa J.;
Rossouw J.; Probstfield J.; Flather M.; Kastelein J.; Newman C.; Shear C.;
Tobert J.; Varigos J.; White H.; Yusuf S.; Mellies M.; McGovern M.;
Barclay J.; Belder R.; Mitchel Y.; Musliner T.; Ansquer J.-C.; Llewellyn
M.; Bortolini M.; Brandrup-Wognsen G.; Bryzinski B.; Olsson G.; Pears J.;
De Micco D.; Buck G.; Herrington W.G.; Kearney P.M.; Kirby A.; Lewis D.A.;
Pollicino C.; Sourjina T.
Institution
(De Lemos, Braunwald, Blazing, Murphy) Phase Z, United States
(Downs, Gotto, Clearfield) AFCAPS/TEXCAPS (AirForce/Texas Coronary
Atherosclerosis Prevention Study), United States
(Holdaas) ALERT (Assessment of Lescol in Transplantation), United States
(Gordon, Davis) ALLHAT (Antihypertensive Lipid Lowering Heart Attack
Trial), United States
(Koren) ALLIANCE (Aggressive Lipid-Lowering Initiation Abates New Cardiac
Events), United States
(Dahlof, Poulter, Sever) ASCOT (Anglo-Scandinavian Cardiac Outcomes
Trial), United States
(Knopp) ASPEN, United States
(Holdaas, Fellstrom, Jardine, Schmieder, Zannad) AURORA, United States
(Goldbourt, Kaplinsky) BIP (Bezafibrate Infarction Prevention Study),
United States
(Colhoun, Betteridge, Durrington, Hitman, Fuller, Neil) CARDS
(Collaborative Atorvastatin Diabetes Study), United States
(Wanner, Krane) 4D (Die Deutsche Diabetes Dialyse Study), United States
(Sacks, Moye, Pfeffer) CARE (Cholesterol and Recurrent Events Study),
United States
(Keech, Barter) FIELD (Fenofibrate Intervention and Event Lowering in
Diabetes), United States
(Tavazzi, Maggioni) GISSI (Gruppo Italiano per Lo Studio della
Sopravvivenza nell'Infarto Miocardico)-Heart Failure, Italy
(Maggioni, Marchioli, Tognoni, Franzosi) GISSI-Prevention, Italy
(Bloomfield, Robins) HIT (Veteran Administration Low HDL Intervention
Trial), United States
(Peto, Keech, Collins, Armitage, Parish, Sleight) HPS (Heart Protection
Study), United States
(Pedersen) IDEAL (Incremental Decrease in Endpoints Through Aggressive
Lipid-lowering), United States
(Ridker) JUPITER, United States
(Holman) LDS (Lipids in Diabetes Study), United States
(Meade) LEADER (Lower Extremity Arterial Disease Event Reduction Trial),
United States
(Keech, Simes, MacMahon, Marschner, Tonkin, Shaw) LIPID (Long-term
Intervention with Pravastatin in Ischaemic Disease), United States
(Serruys) LIPS (Lescol Intervention Prevention Study), United States
(Nakamura) MEGA (Management of Elevated Cholesterol in the Primary
Prevention Group of Adult Japanese), United States
(Knatterud) Post-CABG (Post- Coronary Artery Bypass Graft Study), United
States
(Furberg, Byington) PPP (Pravastatin Pooling Project), United States
(Macfarlane, Cobbe, Ford, Murphy, Blauw, Packard, Shepherd) PROSPER
(Prospective Study of Pravastatin in the Elderly at Risk), United States
(Pedersen, Kjekshus, Wilhelmsen) 4S (Scandinavian Simvastatin Survival
Study), United States
(Braunwald, Murphy, Cannon) PROVE-IT (Pravastatin or Atorvastatin
Evaluation and Infection Therapy), United States
(Peto, Collins, Armitage, Parish, Sleight, Bowman) SEARCH (Study of
Effectiveness of Additional Reductions in Cholesterol and Homocysteine),
United States
(Baigent, Collins, Baxter, Landray) SHARP (Study of Heart and Renal
Protection), United States
(La Rosa) TNT (Testing New Targets), United States
(Rossouw, Probstfield) WHI (Women's Health Initiative), United States
(Macfarlane, Cobbe, Ford, Shepherd) WOSCOPS (West of Scotland Coronary
Prevention Study), United Kingdom
(Mellies, McGovern, Barclay, Belder) Bristol-Myers Squibb, United States
(Mitchel, Musliner) Merck, United States
(Ansquer) Laboratoires Fournier, United States
(Llewellyn) Bayer, United States
(Bortolini) Novartis Pharma, United States
(Brandrup-Wognsen, Bryzinski, Olsson, Pears) AstraZeneca, United States
(De Micco) Pfizer, United States
Publisher
Elsevier B.V. (E-mail: cususerv@lancet.com)
Abstract
Lowering of LDL cholesterol with standard statin regimens reduces the risk
of occlusive vascular events in a wide range of individuals. We aimed to
assess the safety and efficacy of more intensive lowering of LDL
cholesterol with statin therapy. We undertook meta-analyses of individual
participant data from randomised trials involving at least 1000
participants and at least 2 years' treatment duration of more versus less
intensive statin regimens (five trials; 39 612 individuals; median
follow-up 5.1 years) and of statin versus control (21 trials; 129 526
individuals; median follow-up 4.8 years). For each type of trial, we
calculated not only the average risk reduction, but also the average risk
reduction per 1.0 mmol/L LDL cholesterol reduction at 1 year after
randomisation. In the trials of more versus less intensive statin therapy,
the weighted mean further reduction in LDL cholesterol at 1 year was 0.51
mmol/L. Compared with less intensive regimens, more intensive regimens
produced a highly significant 15 (95 CI 11-18; p<0.0001) further reduction
in major vascular events, consisting of separately significant reductions
in coronary death or non-fatal myocardial infarction of 13 (95 CI 7-19;
p<0.0001), in coronary revascularisation of 19 (95 CI 15-24; p<0.0001),
and in ischaemic stroke of 16 (95 CI 5-26; p=0.005). Per 1.0 mmol/L
reduction in LDL cholesterol, these further reductions in risk were
similar to the proportional reductions in the trials of statin versus
control. When both types of trial were combined, similar proportional
reductions in major vascular events per 1.0 mmol/L LDL cholesterol
reduction were found in all types of patient studied (rate ratio [RR]
0.78, 95 CI 0.76-0.80; p<0.0001), including those with LDL cholesterol
lower than 2 mmol/L on the less intensive or control regimen. Across all
26 trials, all-cause mortality was reduced by 10 per 1.0 mmol/L LDL
reduction (RR 0.90, 95 CI 0.87-0.93; p<0.0001), largely reflecting
significant reductions in deaths due to coronary heart disease (RR 0.80,
99 CI 0.74-0.87; p<0.0001) and other cardiac causes (RR 0.89, 99 CI
0.81-0.98; p=0.002), with no significant effect on deaths due to stroke
(RR 0.96, 95 CI 0.84-1.09; p=0.5) or other vascular causes (RR 0.98, 99 CI
0.81-1.18; p=0.8). No significant effects were observed on deaths due to
cancer or other non-vascular causes (RR 0.97, 95 CI 0.92-1.03; p=0.3) or
on cancer incidence (RR 1.00, 95 CI 0.96- 1.04; p=0.9), even at low LDL
cholesterol concentrations. Further reductions in LDL cholesterol safely
produce definite further reductions in the incidence of heart attack, of
revascularisation, and of ischaemic stroke, with each 1.0 mmol/L reduction
reducing the annual rate of these major vascular events by just over a
fifth. There was no evidence of any threshold within the cholesterol range
studied, suggesting that reduction of LDL cholesterol by 2-3 mmol/L would
reduce risk by about 40-50. UK Medical Research Council, British Heart
Foundation, European Community Biomed Programme, Australian National
Health and Medical Research Council, and National Heart
Foundation.<br/>Copyright &#xa9; 2010 Elsevier Ltd.

<25>
Accession Number
51001756
Title
HDL cholesterol and residual risk of first cardiovascular events after
treatment with potent statin therapy: An analysis from the JUPITER trial.
Source
The Lancet. 376 (9738) (pp 333-339), 2010. Date of Publication: 2010.
Author
Ridker P.M.; Genest J.; Boekholdt S.M.; Libby P.; Gotto A.M.; Nordestgaard
B.G.; Mora S.; MacFadyen J.G.; Glynn R.J.; Kastelein J.J.P.
Institution
(Ridker, Mora, MacFadyen, Glynn) Center for Cardiovascular Disease,
Prevention Brigham and Women's Hospital, Harvard Medical School, Boston,
MA 02215, United States
(Ridker, Libby, Mora) Division of Cardiovascular Medicine, Brigham and
Women's Hospital, Harvard Medical School, Boston, MA, United States
(Genest) McGill University Health Centre, Montreal, QC, Canada
(Gotto) Weill Cornell Medical College of Cornell University, New York, NY,
United States
(Nordestgaard) Department of Clinical Biochemistry, Herlev Hospital,
Copenhagen University Hospital, Denmark
(Boekholdt, Kastelein) Department of Cardiology and Vascular Medicine,
Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
Publisher
Elsevier B.V.
Abstract
Summary Background HDL-cholesterol concentrations are inversely associated
with occurrence of cardiovascular events. We addressed, using the JUPITER
trial cohort, whether this association remains when LDL-cholesterol
concentrations are reduced to the very low ranges with high-dose statin
treatment. Participants in the randomised placebo-controlled JUPITER trial
were adults without diabetes or previous cardiovascular disease, and had
baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and
high-sensitivity C-reactive protein of 2 mg/L or more. Participants were
randomly allocated by a computer-generated sequence to receive
rosuvastatin 20 mg per day or placebo, with participants and adjudicators
masked to treatment assignment. In the present analysis, we divided the
participants into quartiles of HDL-cholesterol or apolipoprotein A1 and
sought evidence of association between these quartiles and the JUPITER
primary endpoint of first non-fatal myocardial infarction or stroke,
hospitalisation for unstable angina, arterial revascularisation, or
cardiovascular death. This trial is registered with ClinicalTrials.gov,
number NCT00239681. For 17 802 patients in the JUPITER trial, rosuvastatin
20 mg per day reduced the incidence of the primary endpoint by 44
(p<0.0001). In 8901 (50) patients given placebo (who had a median
on-treatment LDL-cholesterol concentration of 2.80 mmol/L [IQR
2.43-3.24]), HDL-cholesterol concentrations were inversely related to
vascular risk both at baseline (top quartile vs bottom quartile hazard
ratio [HR] 0.54, 95 CI 0.35-0.83, p=0.0039) and on-treatment (0.55,
0.35-0.87, p=0.0047). By contrast, among the 8900 (50) patients given
rosuvastatin 20 mg (who had a median on-treatment LDL-cholesterol
concentration of 1.42 mmol/L [IQR 1.14-1.86]), no significant
relationships were noted between quartiles of HDL-cholesterol
concentration and vascular risk either at baseline (1.12, 0.62-2.03,
p=0.82) or on-treatment (1.03, 0.57-1.87, p=0.97). Our analyses for
apolipoprotein A1 showed an equivalent strong relation to frequency of
primary outcomes in the placebo group but little association in the
rosuvastatin group. Although measurement of HDL-cholesterol concentration
is useful as part of initial cardiovascular risk assessment,
HDL-cholesterol concentrations are not predictive of residual vascular
risk among patients treated with potent statin therapy who attain very low
concentrations of LDL cholesterol. AstraZeneca. &#xa9; 2010 Elsevier Ltd.

<26>
Accession Number
50951900
Title
Effects of tranexamic acid on death, vascular occlusive events, and blood
transfusion in trauma patients with significant haemorrhage (CRASH-2): A
randomised, placebo-controlled trial.
Source
The Lancet. 376 (9734) (pp 23-32), 2010. Date of Publication: 2010.
Author
Olldashi F.; Kerci M.; Zhurda T.; Ruci K.; Banushi A.; Traverso M.S.;
Jimenez J.; Balbi J.; Dellera C.; Svampa S.; Quintana G.; Pinero G.; Teves
J.; Seppelt I.; Mountain D.; Hunter J.; Balogh Z.; Zaman M.; Druwe P.;
Rutsaert R.; Mazairac G.; Pascal F.; Yvette Z.; Chancellin D.; Okwen P.;
Djokam-Liapoe J.; Jangwa E.; Mbuagbaw L.; Fointama N.; Pascal N.; Baillie
F.; Jiang J.-Y.; Gao G.-Y.; Bao Y.-H.; Morales C.; Sierra J.; Naranjo S.;
Correa C.; Gomez C.; Herrera J.; Caicedo L.; Rojas A.; Pastas H.; Miranda
H.; Constain A.; Perdomo M.; Munoz D.; Duarte A.; Vasquez E.; Ortiz C.;
Ayala B.; Delgado H.; Benavides G.; Rosero L.; Mejia-Mantilla J.; Varela
A.; Calle M.; Castillo J.; Garcia A.; Ciro J.; Villa C.; Panesso R.;
Florez L.; Gallego A.; Puentes-Manosalva F.; Medina L.; Marquez K.; Romero
A.R.; Hernandez R.; Gualteros W.; Urbina Z.; Velandia J.; Benitez F.;
Trochez A.; Villarreal A.; Pabon P.; Lopez H.; Quintero L.; Rubiano A.;
Tamayo J.; Pinera M.; Navarro Z.; Rondon D.; Bujan B.; Palacios L.;
Martinez D.; Hernandez Y.; Fernandez Y.; Casola E.; Delgado R.; Herrera
C.; Arbolaez M.; Dominguez M.; Iraola M.; Rojas O.; Ensenat A.; Pastrana
I.; De La Campa S.A.; Fortun T.; Larrea M.; Aragon L.; Madrazo A.; Svoboda
P.; Izurieta M.; Daccach A.; Altamirano M.; Ortega A.; Cardenas B.;
Gonzalez L.; Ochoa M.; Ortega F.; Quichimbo F.; Guinanzaca J.; Zavala I.;
Segura S.; Jerez J.; Acosta D.; Yanez F.; Camacho R.; Khamis H.; Shafei
H.; Kheidr A.; Nasr H.; Mosaad M.; Rizk S.; El Sayed H.; Moati T.; Hokkam
E.; Amin M.; Lowis H.; Fawzy M.; Bedir N.; Aldars M.; Rodriguez V.; Tobar
J.; Alvarenga J.; Shalamberidze B.; Demuria E.; Rtveliashvili N.;
Chutkerashvili G.; Dotiashvili D.; Gogichaishvili T.; Ingorokva G.;
Kazaishvili D.; Melikidze B.; Iashvili N.; Tomadze G.; Chkhikvadze M.;
Khurtsidze L.; Lomidze Z.; Dzagania D.; Kvachadze N.; Gotsadze G.;
Kaloiani V.; Kajaia N.; Dakubo J.; Naaeder S.; Sowah P.; Yusuf A.; Ishak
A.; Selasi-Sefenu P.; Sibiri B.; Sarpong-Peprah S.; Boro T.; Bopaiah K.;
Shetty K.; Subbiah R.; Mulla L.; Doshi A.; Dewan Y.; Grewal S.; Tripathy
P.; Mathew J.; Gupta B.; Lal A.; Choudhury M.; Gupta S.; Chug A.;
Pamidimukkala V.; Jagannath P.; Maharaj M.; Vommi R.; Gudipati N.; Chhang
W.H.; Patel P.; Suthar N.; Banker D.; Patel J.; Dharap S.; Kamble R.;
Patkar S.; Lohiya S.; Saraf R.; Kumar D.; Parihar S.; Mangual R.; Kooper
D.; Mohapatra C.; David S.; Rajaleelan W.; Pangi A.; Saraf V.; Chikareddy
S.; Mankar S.; Golhar A.; Sakhare R.; Wagh N.; Hazarika D.; Chaudhuri P.;
Ketan P.; Purohit G.; Purohit Y.; Pandya M.; Gupta R.; Kiran S.; Walia S.;
Goyal S.; Attri A.; Oberai A.; Oberai M.; Oberoi S.; Tripathi G.K.;
Peettakkandy V.; Karuthillath P.; Vadakammuriyil P.; Pol J.; Pol S.; Saste
M.; Raul S.; Tiwari S.; Nelly N.; Chidambaram M.; Kollengode V.; Thampan
S.; Rajan S.; Raju S.; Sharma R.; Babu S.V.; Sumathi C.; Chatterjee P.;
Agarwal A.; Magar H.; Magar M.; Singh M.; Gupta D.; Haloi K.; Sagdeo V.;
Giri P.; Verma N.; Jariwala R.; Goti A.; Prabhu-Gaonkar A.; Utagi S.;
Joshi M.; Agrawal R.; Sharma G.; Saini G.; Tewari V.; Yadav Y.; Parihar
V.; Venkataramana N.; Rao S.; Reddy N.; Chander S.G.; Hathila V.; Das V.;
Agaja K.; Purohit A.; Lahari A.; Bhagchandani R.; Vidyasagar B.; Sachan
P.K.; Das T.; Vyas S.; Bhattacharjee S.; Sancheti P.; Manoj T.; Moideen
M.; Pansey K.; Chandrasekaran V.P.; Saikia K.; Tata H.; Vhora S.; Shah A.;
Rangad G.; Rajasekaran S.; Shankarlal S.T.; Devadoss S.; Saleem M.; Pillay
H.; Hazarika Z.; Deshmukh P.; Murugappan S.P.; Jaiswal A.; Vangani D.;
Modha P.; Chonzik C.; Praveen M.; Sethurayar V.; Ipe S.; Shetty N.; Jain
V.; Shah K.; Dwikoryanto M.; Golden N.; Atmadjaya K.; Wiargitha K.;
Sudiasa K.; Suwedagatha G.; Bal'afif F.; Budipramana V.; Lemuel A.;
Chandra S.; Ama F.; Sherafatkazemzadeh E.; Moradi E.; Sheikhi A.; Ziaee
A.; Fanaei A.; Hajinasrollah E.; Amini A.; Mohammad B.; Hadi N.; Perone
G.; De Peri E.; Volpi A.; Johnson J.; Abe M.; Mutiso V.; Okanga B.; Ojuka
D.; Abdullah B.; Rahman H.; Noh Y.; Jamaluddin S.; Dawal H.; Roslani A.;
Law C.-W.; Devashanti P.; Wahab Y.; Velaiutham S.; Dato R.; Loria J.;
Montes E.; Gomez E.; Cazales V.; Bautista P.; Bautista R.; Ahumada D.;
Hernandez E.; Velasquez G.; Ortega P.; Lira G.; Estrada F.; Martinez J.;
Olaomi O.; Abubakar Y.; Apollo K.; Badejo O.; Ihekire O.; Casasola J.;
Iribhogbe P.; Oludiran O.; Obeta E.; Okojie C.; Agbon E.U.; Komolafe E.;
Olaleye P.; Uzochukwu T.; Onakpoya U.; Dongo A.; Uhunmwagho O.; Eighemerio
E.; Morgan E.; Thanni L.; Afolabi A.; Akinola T.; Ademola A.; Akute O.;
Khalid L.; Abubakar L.; Aminu M.; Ogirima M.; Attansey A.; Michael D.;
Aremu O.; Olugbenga O.; Ukpong U.; Salman Y.; Obianyo N.; Ani C.; Ezeadawi
R.; Kehinde O.; Olaide A.; Jogo A.; Bitto T.; Anyanwu S.; Mbonu O.;
Oludara M.; Somoye M.; Shehu B.; Ismail N.; Katchy A.; Ndoma-Egba R.;
Grace-Inah N.; Songden Z.; Abdulraheem A.; Otu A.; Nottidge T.; Inyang D.;
Idiapho D.; Giebel H.; Hassan R.; Adisa A.; Akinkuolie A.; Okam K.; Musa
A.; Falope I.; Eze J.; Caballero J.; Azabache W.; Salirrosas O.; Soto A.;
Torres E.; Ramirez G.; Perez M.; Malca C.; Velez J.; Yepez R.; Yupanqui
H.; Lagos P.; Rodriguez D.; Flores J.; Moya A.; Barrionuevo A.;
Gonzales-Portillo M.; Nunez E.; Eldawlatly A.; Al Naami M.; Delvi B.;
Alyafi W.; Djurovic B.; Ng I.; Yaghi A.; Laincz A.; Trenkler S.; Valky J.;
Modiba M.; Legodi P.; Rangaka T.; Wallis L.; Munoz A.; Serrano A.; Misis
M.; Rubi M.; De La Torre V.; Ellawala R.; Wijeratna S.; Gunaratna L.;
Wijayanayaka C.; Nungu K.; Haonga B.; Mtapa G.; Yutthakasemsunt S.;
Kittiwattanagul W.; Piyavechvirat P.; Impool T.; Thummaraj S.; Salaeh R.;
Tangchitvittaya S.; Wattanakrai K.; Soonthornthum C.; Jiravongbunrod T.;
Meephant S.; Subsompon P.; Pensuwan P.; Chamnongwit W.; Jerbi Z.; Cherif
A.; Nash M.; Harris T.; Banerjee J.; Freij R.; Kendall J.; Moore S.;
Townend W.; Cottingham R.; Becker D.; Lloyd S.; Burdett-Smith P.; Mirza
K.; Webster A.; Brady S.; Grocutt A.; Thurston J.; Lecky F.; Goodacre S.;
Mulla Y.; Sakala D.; Chengo C.
Institution
(Olldashi, Kerci, Zhurda, Ruci) National Trauma Centre Hospital, Albania
(Banushi) Spitali Civil Durres, Albania
(Traverso, Jimenez) Hospital Angel Cruz Padilla, Argentina
(Balbi) Hospital Regional Rio Grande, Argentina
(Dellera) Hospital 4 de Junio Dr Ramon Carrillo, Argentina
(Svampa) Hospital Castro Rendon, Argentina
(Quintana) Hospital San Martin de La Plata, Argentina
(Pinero) Hospital Municipal de Agudos Dr Leonidas Lucero, Argentina
(Teves) Hospital Interzonal General de Agudos Dr Oscar Alende, Argentina
(Seppelt) Nepean Hospital, Australia
(Mountain) Sir Charles Gairdner Hospital, Australia
(Hunter, Balogh) Hospital, Australia
(Zaman) United Hospital Limited, Bangladesh
(Druwe, Rutsaert) Sint-Vincentius Hospital, Belgium
(Mazairac) Centre Hospitalier Regional de Namur, Bangladesh
(Pascal, Yvette, Chancellin) Tombel District Hospital, Cameroon
(Okwen) St Theresa's Catholic Medical Centre, Cameroon
(Djokam-Liapoe) Bamenda Provincial Hospital, Cameroon
(Jangwa) Bali District Hospital, Cameroon
(Mbuagbaw) Bafut District Hospital, Cameroon
(Fointama) Fundong District Hospital, Cameroon
(Pascal) St John of God Medical Centre, Cameroon
(Jiang, Gao, Bao) Hamilton General Hospital, Renji Hospital, China
(Morales, Sierra, Naranjo, Correa, Gomez) Hospital Universitario San
Vicente de Paul, Universidad de Antioquia, Colombia
(Herrera, Caicedo, Rojas, Pastas, Miranda) Hospital Universitario, San
Jose de Popayan, Colombia
(Constain, Perdomo, Munoz, Duarte, Vasquez) Hospital Pablo Tobon Uribe,
Colombia
(Ortiz, Ayala, Delgado, Benavides, Rosero) Hospital San Andres de Tumaco,
Colombia
(Mejia-Mantilla, Varela, Calle, Castillo, Garcia) Fundacion Clinica Valle
del Lili, Colombia
(Ciro, Villa, Panesso) Clinica las Americas, Colombia
(Florez, Gallego) Hospital General de Medellin, Colombia
(Puentes-Manosalva, Medina, Marquez) Hospital San Felix ESE, Colombia
(Romero, Hernandez, Martinez) Hospital Universitario del Caribe, Colombia
(Gualteros) Hospital Universitario San Jorge, Colombia
(Urbina, Velandia) Hospital San Rafael Tunja, Colombia
(Benitez, Trochez) Clinica La Estancia SA, Colombia
(Villarreal, Pabon) Fundacion Hospital San Jose de Buga, Colombia
(Delgado) Hospital Civil de Ipiales, Colombia
(Lopez) Hospital Universitario Departamental Narino, Colombia
(Quintero) Hospital Universitario del Valle, Colombia
(Rubiano) Hospital Universitario de Neiva, Colombia
(Tamayo) Hospital Manuel Uribe Angel, Colombia
(Pinera, Navarro, Rondon, Bujan) Hospital Clinico-Quirurgico Docente
Saturnino Lora, Cuba
(Palacios, Martinez, Hernandez, Fernandez) Hospital General Universitario
Carlos Manuel de Cespedes, Cuba
(Casola) Hospital Provincial Docente Manuel Ascunce Domenech, Cuba
(Delgado, Herrera, Arbolaez, Dominguez) Hospital Universitario Arnaldo
Milian Castro, Cuba
(Iraola, Rojas, Ensenat) Hospital Universitario Dr Gustavo Aldereguia
Lima, Cuba
(Pastrana, Rodriguez, De La Campa) Hospital Abel Santamaria Cuadrado, Cuba
(Fortun) Hospital Miguel Enriquez, Cuba
(Larrea) Hospital General Calixto Garcia, Cuba
(Aragon) Hospital Antonio Luaces Iraola, Cuba
(Madrazo) Hospital Provincial Docente VI Lenin, Cuba
(Svoboda) Research Institute for Special Surgery and Trauma, Czechia
(Izurieta, Daccach, Altamirano, Ortega, Cardenas, Gonzalez) Hospital Luis
Vernaza, Ecuador
(Ochoa, Ortega, Quichimbo, Guinanzaca) Hospital Jose Carrasco Arteaga,
Ecuador
(Zavala, Segura) Hospital de Ninos Dr Roberto Gilbert Elizalde, Ecuador
(Jerez) Hospital Naval Guayaquil, Ecuador
(Acosta) Hospital Alcivar, Ecuador
(Yanez) Hospital Dr Rafael Rodriguez Zambrano, Ecuador
(Camacho) Clinica De Especialidades Medicas San Gregorio, Ecuador
(Khamis, Shafei, Kheidr, Nasr, Mosaad, Rizk) Mataria Teaching Hospital,
Egypt
(El Sayed, Moati, Hokkam) Suez Canal University, Egypt
(Amin, Lowis, Fawzy, Bedir, Aldars) Aswan Teaching Hospital, Egypt
(Rodriguez, Tobar, Alvarenga) Hospital Nacional Rosales, El Salvador
(Shalamberidze, Demuria, Rtveliashvili, Chutkerashvili, Dotiashvili)
Tbilisi State University Clinical Hospital 'I Javakhishvili', Georgia
(Gogichaishvili, Ingorokva, Kazaishvili, Melikidze, Iashvili) Tbilisi
First Hospital, University Clinic, Neurosurgery Center, Georgia
(Tomadze, Chkhikvadze, Khurtsidze, Lomidze, Dzagania, Kvachadze, Gotsadze,
Kaloiani) Tbilisi City Hospital, Tbilisi State Medical University ER
Department, Georgia
(Kajaia) Institute of Critical Care Medicine, Georgia
(Dakubo, Naaeder, Sowah) Korle Bu Teaching Hospital, Ghana
(Yusuf, Ishak) Nyinahin Government Hospital, Ghana
(Selasi-Sefenu) Sogakope District Hospital, Ghana
(Sibiri) Methodist Hospital, Ghana
(Sarpong-Peprah) WenchiEffia Nkwanta Regional Hospital, Ghana
(Boro) Saint Theresa's Hospital, Ghana
(Bopaiah, Shetty, Subbiah, Mulla, Doshi) Medical Trust Hospital Kochi,
India
(Dewan, Grewal, Tripathy, Mathew, Gupta) Christian Medical College
Ludhiana, India
(Lal, Choudhury) Aditya Neuroscience Centre, India
(Gupta, Gupta, Chug) Sri Sai Hospital, India
(Pamidimukkala, Jagannath, Maharaj, Vommi, Gudipati) Care Hospital, India
(Chhang) North Bengal Neuro Research Centre, India
(Patel, Suthar, Banker, Patel) Sheth VS General Hospital and NHL Municipal
College, India
(Dharap, Kamble, Patkar, Lohiya) LTM Medical College and General Hospital,
India
(Saraf, Kumar, Parihar, Gupta) Government Medical College and Associated
Hospitals Jammu, India
(Mangual, Kooper, Mohapatra) MKCG Medical College, India
(David, Rajaleelan) Christian Medical College Hospital Vellore, India
(Pangi, Saraf, Chikareddy) KLE Hospital and Medical Research Centre, India
(Mankar, Golhar, Sakhare, Wagh) NKP Salve Institute of Medical Sciences
and Lata Mangeshkar Hospital, India
(Lal, Hazarika) Sanjivani Diagnostics and Hospital, India
(Chaudhuri) Parkar Hospital, India
(Ketan) Jeevan Jyoti Hospital and Research Centre, India
(Purohit, Purohit, Pandya) Mansarovar Hospital, India
(Gupta, Kiran, Walia) Postgraduate Institute of Medical Science Rohtak,
India
(Goyal, Goyal, Goyal) Goyal Hospital Jalna, India
(Gupta, Attri, Sharma) Government Medical College Chandigarh, India
(Oberai, Oberai, Oberoi) Oberai Hospital, India
(Tripathi) Rajeev Gandhi Memorial Hospital and Research Centre, India
(Peettakkandy, Karuthillath, Vadakammuriyil) Calicut Medical College
Hospital, India
(Pol, Pol, Saste) Krishnamai Medical and Research Foundation's NIKOP
Hospital, India
(Raul, Tiwari, Nelly) St Stephen's Hospital, India
(Chidambaram) Government Rajaji Hospital, India
(Kollengode, Thampan) Medical College Trivandrum, India
(Rajan, Rajan) Sanjeevani Hospital, India
(Raju, Sharma) Kamineni Hospital, India
(Babu, Sumathi) Sri Sakthi Hospital, India
(Chatterjee, Agarwal) Bhattacharya Orthopaedic and Related Research
Centre, India
(Magar, Magar) Sushrut Hospital, India
(Singh, Gupta) All India Institute of Medical Sciences, India
(Lal, Haloi) GM Hospital (P) LTD, India
(Sagdeo, Giri) Government Medical College and Superspeciality Hospital
Nagpur, India
(Verma, Jariwala, Goti) Government Medical College New Civil Hospital,
India
(Prabhu-Gaonkar, Utagi) Chikitsa Hospital, India
(Joshi, Agrawal) Apollo Health City, India
(Sharma, Saini) Apex Neurotrauma and Superspeciality Hospital, India
(Tewari) Neuro Center Gola Ghat, India
(Yadav, Parihar) NSCB Medical College, India
(Venkataramana, Rao) BGS Global Hospital, India
(Reddy, Chander) Chettinad Hospital and Research Institute, India
(Hathila) Sir Sayajirao General Hospital and Medical College Baroda, India
(Das) Goyal Hospital and Research Centre Jodhpur, India
(Agaja) Krishna Surgical Hospital, Trauma Care Centre, India
(Purohit) Nizam's Institute of Medical Sciences, India
(Lahari) Niramay Hospital, India
(Bhagchandani) Apex Hospital Bhopal, India
(Vidyasagar) Dr Jeyasekharan Medical Trust, India
(Sachan) Himalayan Institute of Medical Sciences, India
(Das) Apollo Gleneagles Hospitals, India
(Vyas) Civil Hospital Gandhinagar, India
(Bhattacharjee) Sukhdev Raj Soin Hospital, India
(Sancheti) Sancheti Institute for Orthopaedics and Rehabilitation, India
(Manoj) St James Hospital, India
(Moideen) Al Shifa Hospital, India
(Pansey) Anant Institute of Medical Sciences, India
(Chandrasekaran) Vinayaka Mission Hospital, India
(Saikia) Gauhati Medical College and Hospital, India
(Tata) Krishna Hospital and Medical Research Centre, India
(Vhora) Ruby Hall Clinic, India
(Shah) Shreejee Hospital, India
(Rangad) Nazareth Hospital, India
(Rajasekaran) Ganga Hospital, India
(Shankarlal) Vadamalayan Hospitals, India
(Devadoss) Devadoss Multispeciality Hospital, India
(Saleem) KIOT Hospital, India
(Pillay) Baby Memorial Hospital, India
(Hazarika) Bethany Hospital, India
(Deshmukh) Suretech Hospital and Research Centre, India
(Murugappan) Surya Hospital, India
(Jaiswal) Apollo Clinic Varanasi, India
(Vangani) Fortis Escorts Hospital, India
(Modha) Gokul Hospital and Trauma Centre, India
(Chonzik) International Hospital Assam, India
(Praveen) Lifeline Multispeciality Hospital, India
(Sethurayar) Meenakshi Mission Hospital and Research Centre, India
(Ipe) MOSC Medical College Hospital, India
(Shetty) MS Ramaiah Memorial Hospital, India
(Shah) Saykhedkar Hospital and Research Centre, India
(Shah) Shanti Mukand Hospital, India
(Jain) Shri KM Memorial Jain Heart and General Hospital, India
(Shah) Usha Hospital, India
(Dwikoryanto) Soebandi Hospital Jember, Indonesia
(Golden, Atmadjaya, Wiargitha, Sudiasa, Suwedagatha) Sanglah General
Hospital, Indonesia
(Bal'afif) Saiful Anwar General Hospital, Indonesia
(Budipramana, Lemuel) Dr Soetomo General Hospital, Indonesia
(Chandra) Cipto Mangunkusumo Hospital, Indonesia
(Ama) Muhammadiyah Lamongan Hospital, Indonesia
(Sherafatkazemzadeh, Moradi, Sheikhi) Nemazi Hospital, Iran, Islamic
Republic of
(Ziaee, Fanaei) Erfan Hospital, Iran, Islamic Republic of
(Hajinasrollah) Loqman Medical Center, Iran, Islamic Republic of
(Amini) Imam Hosain Hospital, Iran, Islamic Republic of
(Mohammad, Hadi) Diwaniyah College of Medicine, Iraq
(Perone, De Peri) Spedali Civili di Brescia, Italy
(Volpi) Azienda Ospedaliera Di Parma, Italy
(Johnson) University Hospital of the West Indies, Jamaica
(Abe) Fukuoka University Hospital, Japan
(Mutiso, Okanga) Kenyatta National Hospital, Kenya
(Ojuka) Kapenguria District Hospital, Kenya
(Abdullah, Rahman, Noh) Hospital University Science Malaysia, Malaysia
(Jamaluddin, Dawal) Sungai Buloh Hospital, Malaysia
(Roslani, Law, Devashanti) University of Malaya Medical Centre, Malaysia
(Wahab, Velaiutham) Hospital Tengku Ampuan Rahimah, Malaysia
(Dato) Ampang Hospital, Malaysia
(Loria, Montes, Gomez, Cazales, Bautista) Hospital General Regional 25,
Mexico
(Bautista, Ahumada, Hernandez, Velasquez) Hospital Gustavo Rovirosa,
Mexico
(Ortega, Lira, Estrada) Hospital General de Uruapan Dr Pedro Daniel
Martinez, Mexico
(Martinez) Hospital General Ecatepec Las Americas, Mexico
(Martinez) Hospital General La Perla, Mexico
(Olaomi, Abubakar, Apollo, Badejo, Ihekire) Hospital General de Ecatepec
Dr Jose Maria Rodriguez, Mexico
(Casasola) National Hospital Abuja, Nigeria
(Iribhogbe, Oludiran, Obeta, Okojie, Agbon) University of Benin Teaching
Hospital, Nigeria
(Komolafe, Olaleye, Uzochukwu, Onakpoya) Obafemi Awolowo University
Teaching Hospitals, Nigeria
(Dongo, Uhunmwagho, Eighemerio, Morgan) Irrua Specialist Teaching
Hospital, Nigeria
(Thanni) Olabisi Onabanjo University Teaching Hospital, Nigeria
(Afolabi, Akinola, Ademola, Akute) University College Hospital Ibadan,
Nigeria
(Khalid, Abubakar, Aminu, Ogirima) Ahmadu Bello University Teaching
Hospital, Nigeria
(Attansey, Michael, Aremu) Baptist Medical Centre, Nigeria
(Olugbenga, Ukpong, Salman) University of Ilorin Teaching Hospital,
Nigeria
(Obianyo, Ani, Ezeadawi) Enugu State University Teaching Hospital, Nigeria
(Kehinde, Olaide) LAUTECH Teaching Hospital, Nigeria
(Jogo, Bitto) Federal Medical Centre Makurdi, Nigeria
(Anyanwu, Mbonu) Nnamdi Azikiwe University Teaching Hospital, Nigeria
(Oludara, Somoye) Lagos State University Teaching Hospital, Nigeria
(Shehu, Ismail) Usmanu Danfodiyo University Teaching Hospital, Nigeria
(Katchy) National Orthopaedic Hospital Enugu, Nigeria
(Ndoma-Egba, Grace-Inah) University of Calabar Teaching Hospital, Nigeria
(Songden, Abdulraheem) University of Abuja Teaching Hospital, Nigeria
(Otu, Nottidge) University of Uyo Teaching Hospital, Nigeria
(Inyang, Idiapho) Federal Medical Centre Yenagoa, Nigeria
(Giebel) Seventh Day Adventist Hospital, Nigeria
(Hassan) Federal Medical Centre Birnin-Kebbi, Nigeria
(Adisa) Abia State University Teaching Hospital, Nigeria
(Akinkuolie) Wesley Guild Hospital, Nigeria
(Okam) Federal Medical Centre Umuahia, Nigeria
(Musa) University of Maiduguri Teaching Hospital, Nigeria
(Falope) National Orthopaedic Hospital Igbobi, Nigeria
(Eze) University of Nigeria Teaching Hospital Enugu, Nigeria
(Caballero, Azabache, Salirrosas) Hospital Regional Docente de Trujillo,
Peru
(Soto, Torres, Ramirez, Perez) Hospital Nacional Hipolito Unanue, Peru
(Malca) Clinica Santa Ana, Peru
(Velez) Hospital La Caleta, Peru
(Yepez) Hospital Nacional Sergio E Bernales, Peru
(Yupanqui) Hospital de Apoyo de Sullana, Peru
(Lagos) Hospital IV Essalud Huancayo, Peru
(Rodriguez) Hospital Nacional Arzobispo Loayza, Peru
(Flores) Hospital Municipal Los Olivos, Peru
(Moya) Hospital Jose Cayetano Heredia, Peru
(Barrionuevo) Hospital Nacional Carlos Alberto Seguin Escobedo, Peru
(Gonzales-Portillo) Hospital Nacional Dos De Mayo, Peru
(Nunez) Hospital Nacional Cayetano Heredia, Peru
(Eldawlatly, Al Naami, Delvi) King Khalid University Hospital, Saudi
Arabia
(Alyafi) King Khalid National Guard Hospital, Saudi Arabia
(Djurovic) Klinicki Centar Srbije, Serbia
(Ng) National Neuroscience Institute, Singapore
(Yaghi) FNsP Ruzinov, Slovakia
(Laincz) NsP Poprad, Slovakia
(Trenkler) NsP JA Reiman Hospital, Slovakia
(Valky) Faculty Hospital F D Roosevelta, Slovakia
(Modiba, Legodi, Rangaka) Dr George Mukhari Hospital, South Africa
(Wallis) George Provincial Hospital, South Africa
(Munoz) Hospital Universitario Virgen del Rocio, Spain
(Serrano) Hospital Ramon y Cajal de Madrid, Spain
(Misis) Hospital Universitario Germans Trias i Pujol, Spain
(Rubi) Hospital Torrecardenas, Spain
(De La Torre) Hospital Universitario Virgen de la Victoria, Spain
(Ellawala, Wijeratna, Gunaratna, Wijayanayaka) National Hospital of Sri
Lanka, Sri Lanka
(Nungu, Haonga, Mtapa) Muhimbili Orthopaedic Institute, Tanzania
(Yutthakasemsunt, Kittiwattanagul, Piyavechvirat, Impool, Thummaraj) Khon
Kaen Regional Hospital, Thailand
(Salaeh) Pattani Hospital, Thailand
(Tangchitvittaya) Suratthani Hospital, Thailand
(Wattanakrai, Soonthornthum, Jiravongbunrod) Bhumibol Adulyadej Hospital,
Thailand
(Meephant) Lampang Hospital, Thailand
(Subsompon) Rayong Hospital, Thailand
(Pensuwan) Roi-Et Hospital, Thailand
(Chamnongwit) Phrae Hospital, Thailand
(Jerbi, Cherif) Hospital Habib Thameur, Tunisia
(Nash) University Hospital of North Staffordshire, United Kingdom
(Harris) Royal London Hospital, United Kingdom
(Banerjee) Leicester Royal Infirmary, United Kingdom
(Freij) Nottingham University Hospitals NHS Trust, United Kingdom
(Kendall) Frenchay Hospital, United Kingdom
(Moore) Countess of Chester Hospital, United Kingdom
(Townend) Hull Royal Infirmary, United Kingdom
(Cottingham) Royal Sussex County Hospital, United Kingdom
(Becker) Derby Hospitals NHS Trust, United Kingdom
(Lloyd) Bedford Hospital NHS Trust, United Kingdom
(Burdett-Smith) Royal Liverpool University Hospital, United Kingdom
(Mirza) Colchester General Hospital, United Kingdom
(Webster) Royal Lancaster Infirmary, United Kingdom
(Brady, Grocutt) Worthing Hospital, United Kingdom
(Thurston) Darent Valley Hospital, United Kingdom
(Lecky) Hope Hospital, United Kingdom
(Goodacre) Northern General Hospital, United Kingdom
(Mulla, Sakala) University Teaching Hospital, Lusaka, Zambia
(Chengo) Nchanga North General Hospital, Zambia
Publisher
Elsevier B.V.
Abstract
Background Tranexamic acid can reduce bleeding in patients undergoing
elective surgery. We assessed the effects of early administration of a
short course of tranexamic acid on death, vascular occlusive events, and
the receipt of blood transfusion in trauma patients. Methods This
randomised controlled trial was undertaken in 274 hospitals in 40
countries. 20 211 adult trauma patients with, or at risk of, significant
bleeding were randomly assigned within 8 h of injury to either tranexamic
acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or
matching placebo. Randomisation was balanced by centre, with an allocation
sequence based on a block size of eight, generated with a computer random
number generator. Both participants and study staff (site investigators
and trial coordinating centre staff ) were masked to treatment allocation.
The primary outcome was death in hospital within 4 weeks of injury, and
was described with the following categories: bleeding, vascular occlusion
(myocardial infarction, stroke and pulmonary embolism), multiorgan
failure, head injury, and other. All analyses were by intention to treat.
This study is registered as ISRCTN86750102, Clinicaltrials.gov
NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919.
Findings 10 096 patients were allocated to tranexamic acid and 10 115 to
placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause
mortality was significantly reduced with tranexamic acid (1463 [14.5%]
tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91,
95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was
significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95%
CI 0.76-0.96; p=0.0077). Interpretation Tranexamic acid safely reduced the
risk of death in bleeding trauma patients in this study. On the basis of
these results, tranexamic acid should be considered for use in bleeding
trauma patients. Funding UK NIHR Health Technology Assessment programme,
Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.

<27>
Accession Number
50914248
Title
Association of estimated glomerular filtration rate and albuminuria with
all-cause and cardiovascular mortality in general population cohorts: a
collaborative meta-analysis.
Source
The Lancet. 375 (9731) (pp 2073-2081), 2010. Date of Publication:
20100612/18.
Author
Matsushita K.; van der Velde M.; Astor B.C.; Woodward M.; Levey A.S.; de
Jong P.E.; Coresh J.; Gansevoort R.T.; El-Nahas M.; Eckardt K.-U.; Kasiske
B.L.; Tonelli M.; Hemmelgarn B.; Wang Y.; Atkins R.C.; Polkinghorne K.R.;
Chadban S.J.; Shankar A.; Klein R.; Klein B.E.K.; Wang H.; Wang F.; Zhang
L.; Liu L.; Jafar T.; Islam M.; Hatcher J.; Poulter N.; Chaturvedi N.;
Rothenbacher D.; Brenner H.; Raum E.; Koenig W.; Fox C.S.; Hwang S.-J.;
Meigs J.B.; Cirillo M.; Hallan S.; Lydersen S.; Holmen J.; Shlipak M.;
Sarnak M.J.; Katz R.; Fried L.P.; Roderick P.; Nitsch D.; Fletcher A.;
Bulpitt C.; Ohkubo T.; Metoki H.; Nakayama M.; Kikuya M.; Imai Y.; Jassal
S.K.; Barrett-Connor E.; Bergstrom J.; Warnock D.G.; Muntner P.; Judd S.;
McClellan W.M.; Cushman M.; Howard G.; McClure L.A.; Jee S.H.; Kimm H.;
Yun J.E.; Wen C.-P.; Wen S.-F.; Tsao C.-K.; Tsai M.-K.; Arnlov J.; Auguste
P.; Veldhuis K.; Camarata L.; Thomas B.; Manley T.
Institution
(Matsushita, Astor, Coresh) Department of Epidemiology, Johns Hopkins
Bloomberg School of Public Health, Baltimore, MD, United States
(van der Velde, de Jong, Gansevoort) Department of Nephrology, University
Medical Center Groningen, University of Groningen, Groningen, Netherlands
(Woodward) George Institute, University of Sydney, Sydney, Australia
(Levey) Division of Nephrology, Tufts Medical Center, Boston, MA, United
States
(Tonelli, Hemmelgarn) AKDN
(Matsushita, Astor, Coresh, Wang) ARIC
(Shlipak, Sarnak, Katz, Fried) CHS, United States
(Islam, Hatcher, Poulter, Chaturvedi) COBRA, Pakistan
(Rothenbacher, Brenner, Raum, Koenig) ESTHER, Germany
Publisher
Elsevier B.V.
Abstract
Background: Substantial controversy surrounds the use of estimated
glomerular filtration rate (eGFR) and albuminuria to define chronic kidney
disease and assign its stages. We undertook a meta-analysis to assess the
independent and combined associations of eGFR and albuminuria with
mortality. <br/>Method(s): In this collaborative meta-analysis of general
population cohorts, we pooled standardised data for all-cause and
cardiovascular mortality from studies containing at least 1000
participants and baseline information about eGFR and urine albumin
concentrations. Cox proportional hazards models were used to estimate
hazard ratios (HRs) for all-cause and cardiovascular mortality associated
with eGFR and albuminuria, adjusted for potential confounders.
<br/>Finding(s): The analysis included 105 872 participants (730 577
person-years) from 14 studies with urine albumin-to-creatinine ratio (ACR)
measurements and 1 128 310 participants (4 732 110 person-years) from
seven studies with urine protein dipstick measurements. In studies with
ACR measurements, risk of mortality was unrelated to eGFR between 75
mL/min/1.73 m² and 105 mL/min/1.73 m² and increased
at lower eGFRs. Compared with eGFR 95 mL/min/1.73 m², adjusted
HRs for all-cause mortality were 1.18 (95% CI 1.05-1.32) for eGFR 60
mL/min/1.73 m², 1.57 (1.39-1.78) for 45 mL/min/1.73
m², and 3.14 (2.39-4.13) for 15 mL/min/1.73 m². ACR
was associated with risk of mortality linearly on the log-log scale
without threshold effects. Compared with ACR 0.6 mg/mmol, adjusted HRs for
all-cause mortality were 1.20 (1.15-1.26) for ACR 1.1 mg/mmol, 1.63
(1.50-1.77) for 3.4 mg/mmol, and 2.22 (1.97-2.51) for 33.9 mg/mmol. eGFR
and ACR were multiplicatively associated with risk of mortality without
evidence of interaction. Similar findings were recorded for cardiovascular
mortality and in studies with dipstick measurements.
<br/>Interpretation(s): eGFR less than 60 mL/min/1.73 m² and
ACR 1.1 mg/mmol (10 mg/g) or more are independent predictors of mortality
risk in the general population. This study provides quantitative data for
use of both kidney measures for risk assessment and definition and staging
of chronic kidney disease. <br/>Funding(s): Kidney Disease: Improving
Global Outcomes (KDIGO), US National Kidney Foundation, and Dutch Kidney
Foundation. &#xa9; 2010 Elsevier Ltd. All rights reserved.

<28>
Accession Number
50905046
Title
Effects of fibrates on cardiovascular outcomes: a systematic review and
meta-analysis.
Source
The Lancet. 375 (9729) (pp 1875-1884), 2010. Date of Publication:
20100529/0604.
Author
Jun M.; Foote C.; Lv J.; Neal B.; Patel A.; Nicholls S.J.; Grobbee D.E.;
Cass A.; Chalmers J.; Perkovic V.
Institution
(Jun, Foote, Lv, Neal, Patel, Cass, Chalmers, Perkovic) The George
Institute for International Health, University of Sydney, Sydney,
Australia
(Lv) Peking University First Hospital, Beijing, China
(Nicholls) Departments of Cardiovascular Medicine and Cell Biology,
Cleveland Clinic, Cleveland, OH, United States
(Grobbee) Julius Centre, University Medical Centre, Utrecht, Netherlands
Publisher
Elsevier B.V.
Abstract
Background: Several clinical trials have reported inconsistent findings
for the effect of fibrates on cardiovascular risk. We undertook a
systematic review and meta-analysis to investigate the effects of fibrates
on major clinical outcomes. <br/>Method(s): We systematically searched
Medline, Embase, and the Cochrane Library for trials published between
1950 and March, 2010. We included prospective randomised controlled trials
assessing the effects of fibrates on cardiovascular outcomes compared with
placebo. Summary estimates of relative risk (RR) reductions were
calculated with a random effects model. Outcomes analysed were major
cardiovascular events, coronary events, stroke, heart failure, coronary
revascularisation, all-cause mortality, cardiovascular death, non-vascular
death, sudden death, new onset albuminuria, and drug-related adverse
events. <br/>Finding(s): We identified 18 trials providing data for 45 058
participants, including 2870 major cardiovascular events, 4552 coronary
events, and 3880 deaths. Fibrate therapy produced a 10% RR reduction (95%
CI 0-18) for major cardiovascular events (p=0.048) and a 13% RR reduction
(7-19) for coronary events (p<0.0001), but had no benefit on stroke (-3%,
-16 to 9; p=0.69). We noted no effect of fibrate therapy on the risk of
all-cause mortality (0%, -8 to 7; p=0.92), cardiovascular mortality (3%,
-7 to 12; p=0.59), sudden death (11%, -6 to 26; p=0.19), or non-vascular
mortality (-10%, -21 to 0.5; p=0.063). Fibrates reduced the risk of
albuminuria progression by 14% (2-25; p=0.028). Serious drug-related
adverse events were not significantly increased by fibrates (17 413
participants, 225 events; RR 1.21, 0.91-1.61; p=0.19), although increases
in serum creatinine concentrations were common (1.99, 1.46-2.70;
p<0.0001). <br/>Interpretation(s): Fibrates can reduce the risk of major
cardiovascular events predominantly by prevention of coronary events, and
might have a role in individuals at high risk of cardiovascular events and
in those with combined dyslipidaemia. <br/>Funding(s): National Health and
Medical Research Council of Australia. &#xa9; 2010 Elsevier Ltd. All
rights reserved.

<29>
Accession Number
50840496
Title
Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary
stents in routine clinical care (SORT OUT III): a randomised controlled
superiority trial.
Source
The Lancet. 375 (9720) (pp 1090-1099), 2010. Date of Publication:
20100327/0402.
Author
Rasmussen K.; Maeng M.; Kaltoft A.; Thayssen P.; Kelbaek H.; Tilsted H.H.;
Abildgaard U.; Christiansen E.H.; Engstrom T.; Krusell L.R.; Ravkilde J.;
Hansen P.R.; Hansen K.N.; Abildstrom S.Z.; Aaroe J.; Jensen J.S.;
Kristensen S.D.; Botker H.E.; Madsen M.; Johnsen S.P.; Jensen L.O.;
Sorensen H.T.; Thuesen L.; Lassen J.F.
Institution
(Rasmussen, Tilsted, Ravkilde, Aaroe) Department of Cardiology, Aarhus
University Hospital, Aalborg Hospital, Aalborg, Denmark
(Madsen, Johnsen, Sorensen) Department of Clinical Epidemiology, Aarhus
University Hospital, Aalborg Hospital, Aalborg, Denmark
(Johnsen) Centre for Cardiovascular Research, Aarhus University Hospital,
Aalborg Hospital, Aalborg, Denmark
(Maeng, Kaltoft, Christiansen, Krusell, Kristensen, Botker, Jensen,
Thuesen, Lassen) Department of Cardiology, Aarhus University Hospital,
Skejby, Aarhus, Denmark
(Thayssen, Hansen, Jensen) Department of Cardiology, Odense University
Hospital, Odense, Denmark
(Kelbaek, Engstrom) Department of Cardiology, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
(Abildgaard, Hansen, Jensen) Department of Cardiology, Gentofte University
Hospital, Copenhagen, Denmark
(Abildstrom) National Institute of Public Health, University of Southern
Denmark, Copenhagen, Denmark
Publisher
Elsevier B.V.
Abstract
Background: In low-risk patients, the zotarolimus-eluting stent has been
shown to reduce rates of restenosis without increasing the risk of stent
thrombosis. We compared the efficacy and safety of the zotarolimus-eluting
stent versus the sirolimus-eluting stent in patients with coronary artery
disease who were receiving routine clinical care with no direct follow-up.
<br/>Method(s): We did a single-blind, all-comer superiority trial in
adult patients with chronic stable coronary artery disease or acute
coronary syndromes, and at least one target lesion. Patients were treated
at one of five percutaneous coronary intervention centres between January,
2006, and August, 2007. Computer-generated block randomisation and a
telephone allocation service were used to randomly assign patients to
receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for
follow-up were obtained from national Danish administrative and
health-care registries. The primary endpoint was a composite of major
adverse cardiac events within 9 months: cardiac death, myocardial
infarction, and target vessel revascularisation. Intention-to-treat
analyses were done at 9-month and 18-month follow-up. This trial is
registered with ClinicalTrials.gov, number NCT00660478. <br/>Finding(s):
1162 patients (1619 lesions) were assigned to receive the
zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the
sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and
six patients were lost to follow-up. All randomly assigned patients were
included in analyses at 9-month follow-up; 2200 patients (94%) had
completed 18-month follow-up by the time of our assessment. At 9 months,
the primary endpoint had occurred in a higher proportion of patients
treated with the zotarolimus-eluting stent than in those treated with the
sirolimus-eluting stent (72 [6%] vs 34 [3%]; HR 2.15, 95% CI 1.43-3.23;
p=0.0002). At 18-month follow-up, this difference was sustained (113 [10%]
vs 53 [5%]; 2.19, 1.58-3.04; p<0.0001). For patients receiving the
zotarolimus-eluting stent and those receiving the sirolimus-eluting stent,
all cause-mortality was similar at 9-month follow-up (25 [2%] vs 18 [2%];
1.40, 0.76-2.56; p=0.28), but was significantly different at 18-month
follow-up (51 [4%] vs 32 [3%]; 1.61, 1.03-2.50; p=0.035).
<br/>Interpretation(s): The sirolimus-eluting stent is superior to the
zotarolimus-eluting stent for patients receiving routine clinical care.
<br/>Funding(s): Cordis and Medtronic. &#xa9; 2010 Elsevier Ltd. All
rights reserved.

<30>
Accession Number
50625883
Title
Bivalirudin in patients undergoing primary angioplasty for acute
myocardial infarction (HORIZONS-AMI): 1-year results of a randomised
controlled trial.
Source
The Lancet. 374 (9696) (pp 1149-1159), 2009. Date of Publication: 09 Oct
2009.
Author
Mehran R.; Lansky A.J.; Witzenbichler B.; Guagliumi G.; Peruga J.Z.;
Brodie B.R.; Dudek D.; Kornowski R.; Hartmann F.; Gersh B.J.; Pocock S.J.;
Wong S.C.; Nikolsky E.; Gambone L.; Vandertie L.; Parise H.; Dangas G.D.;
Stone G.W.
Institution
(Mehran, Lansky, Nikolsky, Gambone, Vandertie, Parise, Dangas, Stone) New
York-Presbyterian Hospital, the Cardiovascular Research Foundation, New
York, NY, United States
(Witzenbichler) Charite Campus Benjamin Franklin, Berlin, Germany
(Guagliumi) Ospedali Riuniti di Bergamo, Bergamo, Italy
(Peruga) Silesian Center for Heart Disease, Lodz, Poland
(Brodie) LeBauer Cardiovascular Research Foundation, Moses Cone Hospital,
Greensboro, NC, United States
(Dudek) Jagiellonian University, Krakow, Poland
(Kornowski) Rabin Medical Center, Petach Tikva, Israel
(Hartmann) Universitatsklinikum Schleswig-Holstein, Lubeck, Germany
(Gersh) Mayo Clinic, Rochester, MN, United States
(Pocock) London School of Hygiene and Tropical Medicine, London, United
Kingdom
(Wong) New York-Presbyterian Hospital, Weill Cornell Medical Center, New
York, NY, United States
Publisher
Elsevier B.V.
Abstract
Background: In the HORIZONS-AMI trial, patients with acute ST-segment
elevation myocardial infarction (STEMI) undergoing percutaneous coronary
intervention (PCI) who were treated with the thrombin inhibitor
bivalirudin had substantially lower 30-day rates of major haemorrhagic
complications and net adverse clinical events than did patients assigned
to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Here, we assess
whether these initial benefits were maintained at 1 year of follow-up.
<br/>Method(s): Patients aged 18 years or older were eligible for
enrolment in this multicentre, open-label, randomised controlled trial if
they had STEMI, presented within 12 h after the onset of symptoms, and
were undergoing primary PCI. 3602 eligible patients were randomly assigned
by interactive voice response system in a 1:1 ratio to receive bivalirudin
(0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion;
n=1800) or heparin plus a GPI (control; 60 IU/kg intravenous bolus
followed by boluses with target activated clotting time 200-250 s;
n=1802). The two primary trial endpoints were major bleeding and net
adverse clinical events (NACE; consisting of major bleeding or composite
major adverse cardiovascular events [MACE; death, reinfarction, target
vessel revascularisation for ischaemia, or stroke]). This prespecified
analysis reports data for the 1-year follow-up. Analysis was by intention
to treat. Patients with missing data were censored at the time of
withdrawal from the study or at last follow-up. This trial is registered
with ClinicalTrials.gov, number NCT00433966. <br/>Finding(s): 1-year data
were available for 1696 patients in the bivalirudin group and 1702
patients in the control group. Reasons for participant dropout were loss
to follow-up and withdrawal of consent. The rate of NACE was lower in the
bivalirudin group than in the control group (15.6% vs 18.3%, hazard ratio
[HR] 0.83, 95% CI 0.71-0.97, p=0.022), as a result of a lower rate of
major bleeding in the bivalirudin group (5.8% vs 9.2%, HR 0.61, 0.48-0.78,
p<0.0001). The rate of MACE was similar between groups (11.9% vs 11.9%, HR
1.00, 0.82-1.21, p=0.98). The 1-year rates of cardiac mortality (2.1% vs
3.8%, HR 0.57, 0.38-0.84, p=0.005) and all-cause mortality (3.5% vs 4.8%,
HR 0.71, 0.51-0.98, p=0.037) were lower in the bivalirudin group than in
the control group. <br/>Interpretation(s): In patients with STEMI
undergoing primary PCI, anticoagulation with bivalirudin reduced the rates
of net adverse clinical events and major bleeding at 1 year compared with
treatment with heparin plus a GPI. This finding has important clinical
implications for the selection of optimum treatment strategies for
patients with STEMI. <br/>Funding(s): Cardiovascular Research Foundation,
with unrestricted grant support from Boston Scientific Corporation and The
Medicines Company. &#xa9; 2009 Elsevier Ltd. All rights reserved.

<31>
Accession Number
50625882
Title
Otamixaban for the treatment of patients with non-ST-elevation acute
coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind,
active-controlled, phase 2 trial.
Source
The Lancet. 374 (9692) (pp 787-795), 2009. Date of Publication:
20090905/11.
Author
Sabatine M.S.; Antman E.M.; Widimsky P.; Ebrahim I.O.; Kiss R.G.; Saaiman
A.; Polasek R.; Contant C.F.; McCabe C.H.; Braunwald E.
Institution
(Sabatine, Antman, Contant, McCabe, Braunwald) TIMI Study Group, Division
of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA,
United States
(Widimsky) Cardiocentre, 3rd Faculty of Medicine, Charles University,
Prague, Czechia
(Ebrahim) Unitas Hospital, Pretoria, South Africa
(Kiss) Research Group for Inflammation Biology and Immunogenomics,
Hungarian Academy of Sciences, Semmelweis University, Budapest, Hungary
(Saaiman) Kuils River Heart Unit, Cape Town, South Africa
(Polasek) Department of Cardiology, District Hospital Liberec, Liberec,
Czechia
Publisher
Elsevier B.V.
Abstract
Background: Otamixaban is an intravenous direct factor Xa inhibitor. We
aimed to assess its efficacy and safety in non-ST-elevation acute coronary
syndromes and to identify the optimum dose range for further assessment in
a phase 3 study. <br/>Method(s): In this double-blind, phase 2 trial
undertaken in 196 sites in 36 countries, 3241 patients with
non-ST-elevation acute coronary syndromes were randomly assigned via a
central, telephone-based interactive voice response system to one of five
doses of otamixaban (0.08 mg/kg bolus followed by infusions of 0.035
[n=125], 0.070 [676], 0.105 [662], 0.140 [658], or 0.175 [671] mg/kg/h) or
to a control of unfractionated heparin (60 IU/kg intravenous bolus
followed by an infusion of 12 IU/kg/h) plus eptifibatide (180 mug/kg
intravenous bolus followed by an infusion of 1.0-2.0 mug/kg/min [n=449]).
Both investigators and patients were unaware of treatment allocation.
Enrolment into the lowest dose group was stopped early at the
recommendation of the Data Monitoring Committee. The primary efficacy
endpoint was a composite of death, myocardial infarction, urgent
revascularisation, or bailout glycoprotein IIb/IIIa inhibitor use up to 7
days. The primary safety endpoint was TIMI major or minor bleeding not
related to coronary-artery bypass grafting. Efficacy analyses were by
intention to treat; safety analyses were in treated patients. This study
is registered with ClinicalTrials.gov, number NCT00317395.
<br/>Finding(s): Rates of the primary efficacy endpoint in the five
otamixaban doses were 7.2% (nine of 125) with 0.035 mg/kg/h, 4.6% (31/676)
with 0.070 mg/kg/h, 3.8% (25/662) with 0.105 mg/kg/h, 3.6% (24/658) with
0.140 mg/kg/h, and 4.3% (29/671) with 0.175 mg/kg/h (p=0.34 for trend). In
the control group, the rate was 6.2% (28/449), yielding relative risks for
the five otamixaban doses of 1.16 (95% CI 0.56-2.38), 0.74 (0.45-1.21),
0.61 (0.36-1.02), 0.58 (0.34-1.00), and 0.69 (0.42-1.15), respectively.
Rates of the primary safety endpoint in the five otamixaban doses were
1.6% (two of 122), 1.6% (11/669), 3.1% (20/651), 3.4% (22/651), and 5.4%
(36/664), respectively (p=0.0001 for trend); the rate in the control group
was 2.7% (12/448). <br/>Interpretation(s): In patients with
non-ST-elevation acute coronary syndromes, otamixaban infusions of
0.100-0.140 mg/kg/h might reduce ischaemic events and have a safety
profile similar to unfractionated heparin plus eptifibatide. Further
testing in a phase 3 trial is warranted. <br/>Funding(s): Sanofi-Aventis.
&#xa9; 2009 Elsevier Ltd. All rights reserved.

<32>
Accession Number
2007355116
Title
Prone positioning in non-intubated patients with COVID-19 associated acute
respiratory failure, the PRO-CARF trial: A structured summary of a study
protocol for a randomised controlled trial.
Source
Trials. 21 (1) (no pagination), 2020. Article Number: 940. Date of
Publication: December 2020.
Author
Ibarra-Estrada M.A.; Marin-Rosales M.; Garcia-Salcido R.; Aguirre-Diaz
S.A.; Vargas-Obieta A.; Chavez-Pena Q.; Lopez-Pulgarin J.A.;
Mijangos-Mendez J.C.; Aguirre-Avalos G.
Institution
(Ibarra-Estrada, Vargas-Obieta, Chavez-Pena, Mijangos-Mendez) Intensive
Care Unit, COVID-19 Unit, Hospital Civil Fray Antonio Alcalde,
Guadalajara, Jalisco, Mexico
(Marin-Rosales) Internal Medidine, COVID-19 Unit, Hospital General de
Occidente, Zapopan, Jalisco, Mexico
(Garcia-Salcido) COVID-19 Unit, Hospital Civil Fray Antonio Alcalde,
Guadalajara, Jalisco, Mexico
(Aguirre-Diaz) Infectious Diseases Department, Hospital Civil Fray Antonio
Alcalde, Guadalajara, Jalisco, Mexico
(Chavez-Pena, Lopez-Pulgarin, Aguirre-Avalos) Centro Universitario de
Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco,
Mexico
(Lopez-Pulgarin, Aguirre-Avalos) Intensive Care Unit, COVID-19 Unit,
Hospital Civil "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico
Publisher
BioMed Central Ltd
Abstract
Objectives: To assess the effect of prone positioning therapy on
intubation rate in awake patients with COVID-19 and acute respiratory
failure. Trial design: This is a two-center parallel group, superiority,
randomized (1:1 allocation ratio) controlled trial. <br/>Participant(s):
All patients admitted to the Hospital Civil de Guadalajara and Hospital
General de Occidente in Mexico for COVID-19 associated acute respiratory
failure and in need of supplementary oxygen through high-flow nasal
cannula are screened for eligibility. Inclusion criteria: all adult
patients admitted to the COVID-19 unit who test positive for COVID-19 by
PCR-test and in need for oxygen are eligible for inclusion. Randomization
starts upon identification of requirement of a fraction of inspired oxygen
>=30% for an oxygen capillary saturation of >=90% Exclusion criteria: less
than 18 years-old, pregnancy, patients with immediate need of invasive
mechanical ventilation (altered mental status, fatigue), vasopressor
requirement to maintain median arterial pressure >65 mmHg,
contraindications for prone positioning therapy (recent abdominal or
thoracic surgery or trauma, facial, pelvic or spine fracture, untreated
pneumothorax, do-not-resuscitate or do-not-intubate order, refusal or
inability of the patient to enroll in the study. Intervention and
comparator: Patients of the intervention group will be asked to remain in
a prone position throughout the day as long as possible, with breaks
according to tolerance. Pillows will be offered for maximizing comfort at
chest, pelvis and knees. Monitoring of vital signs will not be suspended.
Inspired fraction of oxygen will be titrated to maintain a capillary
saturation of 92%-95%. For patients in the control group, prone
positioning will be allowed as a rescue therapy. Staff intensivists will
monitor the patient's status in both groups on a 24/7 basis. All other
treatment will be unchanged and left to the attending physicians. Main
outcomes: Endotracheal intubation rate for mechanical ventilation at 28
days. Randomisation: Patients will be randomly allocated to either prone
positioning or control group at 1:1 ratio. Such randomization will be
computer generated and stratified by center with permuted blocks and
length of 4. Blinding (masking): Due to logistical reasons, only principal
investigators and the data analyst will be blinded to group assignment.
Numbers to be randomised (sample size): With an intubation rate of 60%
according to recent reports from some American centers, and assuming a
decrease to 40% to be clinically relevant, we calculated a total of 96
patients per group, for a beta error of 0.2, and alpha of 0.5. Therefore,
we plan to recruit 200 patients, accounting for minimal losses to follow
up, with 100 non-intubated patients in the prone position group and a 100
in the control group. Trial Status: The local registration number is
048-20, with the protocol version number 2.0. The date of approval is 3rd
May 2020. Recruitment started on 3^rd May and is expected to end
in December 2020. Trial registration: The protocol was retrospectively
registered under the title: "Prone Positioning in Non-intubated Patients
With COVID-19 Associated Acute Respiratory Failure. The PRO-CARF trial" in
ClinicalTrials.gov with the registration number: NCT04477655. Registered
on 20 July 2020. Full protocol: The full protocol is attached as an
additional file, accessible from the Trials website (Additional file 1).
In the interest in expediting dissemination of this material, the familiar
formatting has been eliminated; this Letter serves as a summary of the key
elements of the full protocol. The study protocol has been reported in
accordance with the Standard Protocol Items: Recommendations for Clinical
Interventional Trials (SPIRIT) guidelines (Additional file
2).<br/>Copyright &#xa9; 2020, The Author(s).

<33>
Accession Number
2008596968
Title
The experiences of adult heart, lung, and heart-lung transplantation
recipients: A systematic review of qualitative research evidence.
Source
PLoS ONE. 15 (11 November) (no pagination), 2020. Article Number:
e0241570. Date of Publication: November 2020.
Author
Stubber C.; Kirkman M.
Institution
(Stubber, Kirkman) Global and Women's Health, Public Health and Preventive
Medicine, Monash University, Melbourne, VIC, Australia
Publisher
Public Library of Science
Abstract
Aim To review evidence about the experience of being the recipient of a
donated heart, lungs, or heart and lungs. Design A systematic review
(registered with PROSPERO: CRD42017067218), in accordance with PRISMA
guidelines. Data sources Seven databases and Google Scholar were searched
in May 2017 and July 2019 for papers reporting English-language research
that had used qualitative methods to investigate experiences of adult
recipients. Review methods Quality was assessed and results were analysed
thematically. Results 24 papers (reporting 20 studies) were eligible and
included. Their results were organised into three chronological periods:
pre-transplant (encompassing the themes of 'dynamic psychosocial impact',
'resources and support'), transplant ('The Call', 'intensive care unit'),
and post-transplant ('dynamic psychosocial impact', 'management',
'rejection'). Sub-themes were also identified. It was evident that
contemplating and accepting listing for transplantation entailed or
amplified realisation of the precipitating illness's existential threat.
The period surrounding transplantation surgery was marked by profound,
often surreal, experiences. Thereafter, although life usually improved, it
incorporated unforeseen challenges. The transplantation clinic remained
important to the recipient. The meaning of the clinic and its staff could
be both reassuring (providing care and support) and threatening
(representing onerous medical requirements and potential organ rejection).
Conclusion This review has implications for the psychosocial care of
transplant recipients and indicates the need for further research to gain
insight into the experience of receiving a donated heart and/or lung.
Impact Medical consequences of heart and lung transplantation are well
documented; this is the first systematic review of research using
qualitative methods to investigate the experience of heart, lung, and
heart-and-lung transplantation. The psychosocial impact of transplantation
was found to be dynamic and complex, with notable features evident before,
during, and after transplantation. Clinic staff remained significant to
recipients. It is clear that recipients need continuing psychosocial as
well as medical support.<br/>Copyright &#xa9; 2020 Stubber, Kirkman. This
is an open access article distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution,
and reproduction in any medium, provided the original author and source
are credited.

<34>
Accession Number
634037897
Title
Postneoadjuvant surveillance and surgery as needed compared with
postneoadjuvant surgery on principle in multimodal treatment for
oesophageal cancer: A scoping review protocol.
Source
BMJ Open. 11 (1) (no pagination), 2021. Article Number: e044190. Date of
Publication: 28 Jan 2021.
Author
Schmucker C.; Nagavci B.; Hipp J.; Schmoor C.; Meerpohl J.; Hoeppner J.
Institution
(Schmucker, Nagavci, Meerpohl) Institute for Evidence in Medicine (for
Cochrane Germany Foundation), Medical Center - University of Freiburg,
Faculty of Medicine, University of Freiburg, Freiburg, Baden-Wurttemberg,
Germany
(Hipp, Hoeppner) Center for Surgery, Department of General and Visceral
Surgery, Medical Center, University of Freiburg, Faculty of Medicine,
University of Freiburg, Freiburg, Baden-Wurttemberg, Germany
(Schmoor) Clinical Trials Unit, Medical Center - University of Freiburg,
Faculty of Medicine, University of Freiburg, Freiburg im Breisgau,
Baden-Wurttemberg, Germany
(Meerpohl) Cochrane Germany, Cochrane Germany Foundation, Freiburg,
Germany
(Hoeppner) Department of Surgery, University Medical Center
Schleswig-Holstein, Campus Luebeck, Luebeck, Germany
Publisher
BMJ Publishing Group
Abstract
Introduction In current medical practice of curative treatment for
non-metastatic oesophageal cancer, surgery on principle is carried out by
oesophagectomy after neoadjuvant treatment. However, oesophagectomy is
often associated with postoperative morbidity and mortality. Taking into
account that modern neoadjuvant therapy is effective and many of patients
show no vital tumour cells in the operative specimens, we aim to perform a
scoping review as part of the development phase for a prospectively
planned multicentre randomised controlled trial investigating 'surgery as
needed vs surgery on principle in patients with postneoadjuvant complete
response of oesophageal cancer' (Prospective trial registration number
DRKS00022801). This scoping approach will allow us to finally define
and/or adapt the research question including the design and methodology of
the randomised controlled trial taking into account the findings for
example, research gaps and/or pitfalls in the currently available study
pool addressing this or very similar questions. Methods and analysis To
identify relevant research, we will conduct searches in the electronic
databases Medline, Web of Science Core Collection, Cochrane Library and
Science Direct. We will also check references of relevant studies and
perform a cited reference research (forward citation tracking). Titles and
abstracts of the records identified by the searches will be screened and
full texts of all potentially relevant articles will be obtained. We will
consider randomised trials and non-randomised controlled studies. Data
extraction tables will be set up, including study and patients'
characteristics, aim of study and reported outcomes. We will summarise the
data using tables and figures (eg, bubble plots) to present the research
landscape and to describe potential clusters and/or gaps to support the
planning of a randomised trial in this patient population. Ethics and
dissemination Ethical approval is not required for this scoping review.
Study findings will be shared by publication in a peer-reviewed journal
and by presentation to key stakeholders on scientific meetings.
<br/>Copyright &#xa9; Author(s) (or their employer(s)) 2021. Re-use
permitted under CC BY-NC. No commercial re-use. See rights and
permissions. Published by BMJ.

<35>
Accession Number
2010449457
Title
Meta-analysis of Direct Oral Anticoagulants in Patients With Atrial
Fibrillation and Bioprosthetic Valves.
Source
American Journal of Cardiology. 142 (pp 140-141), 2021. Date of
Publication: 01 Mar 2021.
Author
Kheiri B.; Przybylowicz R.; Simpson T.F.; Alhamoud H.; Osman M.; Dalouk
K.; Nazer B.; Henrikson C.A.; Stecker E.
Institution
(Kheiri, Przybylowicz, Simpson, Dalouk, Nazer, Henrikson, Stecker) Knight
Cardiovascular Institute, Oregon Health & Science University, Portland,
OR, United States
(Alhamoud, Osman) Division of Cardiology, West Virginia University School
of Medicine, Morgantown, WV, United States
Publisher
Elsevier Inc.

<36>
Accession Number
2010384814
Title
Del Nido Cardioplegia in Coronary Artery Bypass Grafting Surgery: A safe,
efficacious and economic alternative to St. Thomas solution; an experience
from a developing nation.
Source
Perfusion (United Kingdom). (no pagination), 2021. Date of Publication:
2021.
Author
Moktan Lama P.B.; Khakural P.; Sigdel S.; Raj Bhatta M.; Sah Teli R.;
Baral R.K.; Bhattarai A.; Pradhan B.; Koirala B.
Institution
(Moktan Lama, Khakural, Raj Bhatta, Sah Teli, Baral, Bhattarai, Koirala)
Department of Cardiothoracic Vascular Surgery, Manmohan Cardiothoracic
Vascular and Transplant Center, Institute of Medicine, Tribhuvan
University, Maharajgunj, Kathmandu, Nepal
(Sigdel, Pradhan) Department of Cardiothoracic and Vascular
Anesthesiology, Manmohan Cardiothoracic Vascular and Transplant Center,
Institute of Medicine, Tribhuvan University, Maharajgunj, Kathmandu, Nepal
Publisher
SAGE Publications Ltd
Abstract
Introduction: del Nido cardioplegia is a newer solution getting popular
worldwide, whereas in Nepal, St. Thomas cardioplegia solution is
conventionally used. There is no national recommendation on cardioplegia
solutions supported by evidences from Nepalese studies. This study aimed
to evaluate and compare the efficacy of these solutions in Nepalese
patients undergoing coronary artery bypass grafting. <br/>Method(s):
Patients undergoing coronary revascularization, from May 2018 to December
2019, were randomized into St. Thomas and del Nido groups based on the
cardioplegia administered, with 45 patients in each group. Preoperative,
intraoperative, and postoperative parameters and cost of cardioplegia
preparation in the two groups were compared. <br/>Result(s): The
cardiopulmonary bypass time (106.13 +/- 24.65 minutes vs 107.62 +/- 18.69
minutes, p = 0.02), aortic cross clamp time (66.22 +/- 15.40 minutes vs
72.07 +/- 12.23 minutes, p = 0.04), volume (1059.22 +/- 100.30 ml vs
1526.67 +/- 271.81 ml, p < 0.001) and number of cardioplegia doses (1.00
+/- 0.00 vs 2.51 +/- 0.66, p < 0.001) were significantly lower with del
Nido cardioplegia. A lower CPK-MB at second post-operative (59.91 +/-
31.62 vs 73.82 +/- 37.25, p = 0.03) and a higher left ventricle ejection
fraction at discharge (56.33 +/- 8.94% vs 50.45 +/- 8.55%, p < 0.001) was
observed in del Nido group. There was one death in St. Thomas group. ICU
and hospital stay were similar in both groups. St. Thomas solution was
found to be costlier than del Nido solution (USD 5.40 +/- 0.96 vs USD 3.50
+/- 0.34, p < 0.001). <br/>Conclusion(s): The del Nido cardioplegia was
found to be efficacious, safe and more economical alternative to St.
Thomas solution.<br/>Copyright &#xa9; The Author(s) 2021.

<37>
Accession Number
2010299211
Title
Integrative transcriptomic, proteomic, and machine learning approach to
identifying feature genes of atrial fibrillation using atrial samples from
patients with valvular heart disease.
Source
BMC Cardiovascular Disorders. 21 (1) (no pagination), 2021. Article
Number: 52. Date of Publication: December 2021.
Author
Liu Y.; Bai F.; Tang Z.; Liu N.; Liu Q.
Institution
(Liu, Bai, Liu, Liu) Department of Cardiovascular Medicine/Cardiac
Catheterization Lab, Second Xiangya Hospital, Central South University,
No. 139 Middle Renmin Road, Changsha, Hunan Province 410011, China
(Tang) Department of Dermatology, Xiangya Hospital, Central South
University, Changsha, Hunan Province, China
Publisher
BioMed Central Ltd
Abstract
Background: Atrial fibrillation (AF) is the most common arrhythmia with
poorly understood mechanisms. We aimed to investigate the biological
mechanism of AF and to discover feature genes by analyzing multi-omics
data and by applying a machine learning approach. <br/>Method(s): At the
transcriptomic level, four microarray datasets (GSE41177, GSE79768,
GSE115574, GSE14975) were downloaded from the Gene Expression Omnibus
database, which included 130 available atrial samples from AF and sinus
rhythm (SR) patients with valvular heart disease. Microarray meta-analysis
was adopted to identified differentially expressed genes (DEGs). At the
proteomic level, a qualitative and quantitative analysis of proteomics in
the left atrial appendage of 18 patients (9 with AF and 9 with SR) who
underwent cardiac valvular surgery was conducted. The machine learning
correlation-based feature selection (CFS) method was introduced to
selected feature genes of AF using the training set of 130 samples
involved in the microarray meta-analysis. The Naive Bayes (NB) based
classifier constructed using training set was evaluated on an independent
validation test set GSE2240. <br/>Result(s): 863 DEGs with FDR < 0.05 and
482 differentially expressed proteins (DEPs) with FDR < 0.1 and fold
change > 1.2 were obtained from the transcriptomic and proteomic study,
respectively. The DEGs and DEPs were then analyzed together which
identified 30 biomarkers with consistent trends. Further, 10 features,
including 8 upregulated genes (CD44, CHGB, FHL2, GGT5, IGFBP2, NRAP,
SEPTIN6, YWHAQ) and 2 downregulated genes (TNNI1, TRDN) were selected from
the 30 biomarkers through machine learning CFS method using training set.
The NB based classifier constructed using the training set accurately and
reliably classify AF from SR samples in the validation test set with a
precision of 87.5% and AUC of 0.995. <br/>Conclusion(s): Taken together,
our present work might provide novel insights into the molecular mechanism
and provide some promising diagnostic and therapeutic targets of
AF.<br/>Copyright &#xa9; 2021, The Author(s).

<38>
Accession Number
2010299065
Title
Infective endocarditis in patients with liver cirrhosis: a systematic
review.
Source
Journal of Chemotherapy. (no pagination), 2021. Date of Publication: 2021.
Author
Ioannou P.; Savva E.; Kofteridis D.P.
Institution
(Ioannou, Savva, Kofteridis) Department of Internal Medicine & Infectious
Diseases, University Hospital of Heraklion, Heraklion, Greece
Publisher
Taylor and Francis Ltd.
Abstract
Liver cirrhosis is an increasing cause of mortality and morbidity in
developed countries. Infective Endocarditis (IE) is an uncommon disease
with notable morbidity and mortality. Even though cirrhosis is associated
with immune dysfunction and increased occurrence of bacterial infection,
IE is infrequently diagnosed in these patients. Thus, the purpose of this
study was to systematically review all published cases of IE in patients
with cirrhosis in the literature. A systematic review of PubMed, Scopus
and Cochrane (through 23^th April 2020) for studies providing
epidemiological, clinical, microbiological as well as treatment data and
outcomes of IE in patients with cirrhosis was performed. A total of 78
studies, containing data of 602 patients, were included. A prosthetic
valve was present in 17.8%, while the most common causative pathogen was
S. aureus in 26% followed by Streptococcus spp in 16.8%. Aortic valve was
the most commonly infected site, followed by mitral valve. Diagnosis was
set with a transthoracic ultrasound in 55.2%, while the diagnosis was set
at autopsy in 16.7%. Fever and heart failure were the most common clinical
presentations. Aminoglycosides, vancomycin, and cephalosporins were the
antimicrobials most frequently used for treatment. Clinical cure was noted
in 68.2%, while overall mortality was 41.4%. This systematic review
thoroughly describes IE in patients with liver cirrhosis and provides
information on epidemiology, clinical presentation, treatment and
outcomes.<br/>Copyright &#xa9; 2021 Edizioni Scientifi che per
l'Informazione su Farmaci e Terapia.

<39>
Accession Number
2010298979
Title
Association between intra-operative cardiac arrest and country Human
Development Index status: a systematic review with meta-regression
analysis and meta-analysis of observational studies^*.
Source
Anaesthesia. (no pagination), 2021. Date of Publication: 2021.
Author
Braz L.G.; Einav S.; Heesen M.A.; Betini M.; Corrente J.E.; Pacchioni M.;
Cury J.B.; Braz M.G.; Braz J.R.C.
Institution
(Braz, Pacchioni, Cury, Braz, Braz) Anaesthesia Cardiac Arrest and
Mortality Study Commission, Department of Surgical Specialties and
Anaesthesiology, Botucatu Medical School, Sao Paulo State University -
UNESP, Botucatu, Brazil
(Einav) Shaare Zedek Medical Centre, Jerusalem, Israel
(Einav) Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem,
Israel
(Heesen) Department of Anaesthesia, Kantonsspital Baden, Baden,
Switzerland
(Betini) Technical Division of Library and Documentation, Institute of
Biosciences, Sao Paulo State University - UNESP, Botucatu, Brazil
(Corrente) Department of Biostatistics, Institute of Biosciences, Sao
Paulo State University - UNESP, Botucatu, Brazil
Publisher
Blackwell Publishing Ltd
Abstract
Intra-operative cardiac arrests differ from most in-hospital cardiac
arrests because they reflect not only the patient's condition but also the
quality of surgery and anaesthesia care provided. We assessed the
relationship between intra-operative cardiac arrest rates and country
Human Development Index (HDI), and the changes occurring in these rates
over time. We searched PubMed, EMBASE, Scopus, LILACS, Web of Science,
CINAHL and SciELO from inception to 29 January 2020. For the global
population, rates of intra-operative cardiac arrest and baseline ASA
physical status were extracted. Intra-operative cardiac arrest rates were
analysed by time, country HDI status and ASA physical status using
meta-regression analysis. Proportional meta-analysis was performed to
compare intra-operative cardiac arrest rates and ASA physical status in
low- vs. high-HDI countries and in two time periods. Eighty-two studies
from 25 countries with more than 29 million anaesthetic procedures were
included. Intra-operative cardiac arrest rates were inversely correlated
with country HDI (p = 0.0001); they decreased over time only in high-HDI
countries (p = 0.040) and increased with increasing ASA physical status (p
< 0.0001). Baseline ASA physical status did not change in high-HDI
countries (p = 0.106), while it decreased over time in low-HDI countries
(p = 0.040). In high-HDI countries, intra-operative cardiac arrest rates
(per 10,000 anaesthetic procedures) decreased from 9.59 (95%CI 6.59-13.16)
pre-1990 to 5.17 (95%CI 4.42-5.97) in 1990-2020 (p = 0.013). During the
same time periods, no improvement was observed in the intra-operative
cardiac arrest rates in low-HDI countries (p = 0.498). Odds ratios of
intra-operative cardiac arrest rates in ASA 3-5 patients were 8.48 (95%CI
1.67-42.99) times higher in low-HDI countries than in high-HDI countries
(p = 0.0098). Intra-operative cardiac arrest rates are related to
country-HDI and decreased over time only in high-HDI countries. The
widening gap in these rates between low- and high-HDI countries needs to
be addressed globally.<br/>Copyright &#xa9; 2021 Association of
Anaesthetists

<40>
Accession Number
2007605810
Title
Pregnancy after Heart Transplantation.
Source
Journal of Cardiac Failure. 27 (2) (pp 176-184), 2021. Date of
Publication: February 2021.
Author
Defilippis E.M.; Kittleson M.M.
Institution
(Defilippis) Division of Cardiology, Columbia University Irving Medical
Center, New York, NY, United States
(Kittleson) Division of Cardiology, Smidt Heart Institute, Cedars-Sinai
Medical Center, Los Angeles, CA, United States
Publisher
Elsevier B.V.
Abstract
As post-transplant survival improves, many heart transplant (HT)
recipients are of, or are surviving to, childbearing age. Solid-organ
transplant recipients who become pregnant should be managed by a
multidisciplinary cardio-obstetrics team, including specialists in
maternal and fetal medicine, cardiology and transplant medicine, as well
as anesthesia, neonatology, psychology, genetics, and social services.
With careful patient selection, pregnancy after HT can been managed
safely. The purpose of this comprehensive review was to summarize the
current evidence and recommendations surrounding preconception counseling,
medical management and surveillance, maternal outcomes, breastfeeding, and
remaining gaps in knowledge.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<41>
Accession Number
2006988157
Title
Clinical Safety Profile of Transendocardial Catheter Injection Systems: A
Plea for Uniform Reporting.
Source
Cardiovascular Revascularization Medicine. 22 (pp 100-108), 2021. Date of
Publication: January 2021.
Author
Raval A.N.; Pepine C.J.
Institution
(Raval) Department of Medicine and Biomedical Engineering, University of
Wisconsin School of Medicine and Public Health, Madison, WI, United States
(Pepine) Division of Cardiovascular Medicine, University of Florida,
Gainsville, FL, United States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to characterize the clinical safety
profile of transendocardial injection catheters (TIC) reported in the
published literature. <br/>Background(s): Transendocardial delivery is a
minimally invasive approach to deliver potential therapeutic agents
directly into the myocardium. The rate of adverse events across TIC is
uncertain. <br/>Method(s): A systematic search was performed for trial
publications using TIC. Procedure-associated adverse event data were
abstracted, pooled and compared across catheters for active treatment and
placebo injected patients. The transendocardial injection associated
serious adverse events (TEI-SAE) was defined as the composite of death,
myocardial infarction, stroke or transient ischemic attack within 30 days
and cardiac perforation causing death or requiring evacuation, serious
intraprocedural arrhythmias and serious coronary artery or peripheral
vascular complications. <br/>Result(s): The search identified 4 TIC
systems: a helical needle (HN), an electro-anatomically tracked straight
needle (EAM-SN), a straight needle without tracking elements (SN), and a
curved needle (CN). Of 1799 patients who underwent transendocardial
injections, the combined TEI-SAE was 3.4% across all catheters, and 1.1%,
3.3%, 7.1%, and 8.3% for HN, EAM-SN, SN and CN, respectively. However, TIC
procedure duration and post procedural cardiac biomarker levels were
reported in only 24% and 36% of published trials, respectively.
<br/>Conclusion(s): Transendocardial injection is associated with varied
TEI-SAE but the data are very limited. The HN catheter appeared to be
associated with lower TEI-SAE, versus other catheters. Procedure duration
and post procedure cardiac biomarker levels were under-reported. Clearly,
standardized, procedure-related event reporting for trials involving
transcatheter delivery would improve our understanding of complications
across different systems.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<42>
Accession Number
2006842729
Title
Machine-Learning-Based In-Hospital Mortality Prediction for Transcatheter
Mitral Valve Repair in the United States.
Source
Cardiovascular Revascularization Medicine. 22 (pp 22-28), 2021. Date of
Publication: January 2021.
Author
Hernandez-Suarez D.F.; Ranka S.; Kim Y.; Latib A.; Wiley J.;
Lopez-Candales A.; Pinto D.S.; Gonzalez M.C.; Ramakrishna H.; Sanina C.;
Nieves-Rodriguez B.G.; Rodriguez-Maldonado J.; Feliu Maldonado R.;
Rodriguez-Ruiz I.J.; da Luz Sant'Ana I.; Wiley K.A.; Cox-Alomar P.;
Villablanca P.A.; Roche-Lima A.
Institution
(Hernandez-Suarez) Division of Cardiovascular Medicine, Department of
Medicine, University of Puerto Rico School of Medicine, San Juan, PR,
United States
(Ranka) Division of Cardiovascular Medicine, Department of Medicine,
University of Kansas School of Medicine, Kansas City, KS, United States
(Kim) Division of Cardiovascular Medicine, Department of Medicine, Yale
University School of Medicine, New Haven, CT, United States
(Latib, Wiley, Gonzalez, Sanina) Division of Cardiology, Department of
Medicine, Montefiore Medical Center/Albert Einstein College of Medicine,
New York, NY, United States
(Lopez-Candales) Division of Cardiology, Department of Medicine,
University of Arkansas for Medical Sciences, Little Rock, AR, United
States
(Pinto) Beth Israel Deaconess Medical Center, Harvard Medical School,
Boston, MA, United States
(Ramakrishna) Division of Cardiovascular and Thoracic Anesthesiology, Mayo
Clinic, Rochester, MN, United States
(Nieves-Rodriguez, Rodriguez-Maldonado, Feliu Maldonado, Rodriguez-Ruiz,
da Luz Sant'Ana, Roche-Lima) Center for Collaborative Research in Health
Disparities, University of Puerto Rico School of Medicine, San Juan, PR,
United States
(Wiley) College of Agriculture and Life Sciences, Cornell University,
Ithaca, NY, United States
(Cox-Alomar) Division of Cardiology, Department of Medicine, Louisiana
State University, New Orleans, LA, United States
(Villablanca) Division of Cardiovascular Medicine, Department of Medicine,
Henry Ford Hospital, Detroit, MI, United States
Publisher
Elsevier Inc.
Abstract
Background: Transcatheter mitral valve repair (TMVR) utilization has
increased significantly in the United States over the last years. Yet, a
risk-prediction tool for adverse events has not been developed. We aimed
to generate a machine-learning-based algorithm to predict in-hospital
mortality after TMVR. <br/>Method(s): Patients who underwent TMVR from
2012 through 2015 were identified using the National Inpatient Sample
database. The study population was randomly divided into a training set (n
= 636) and a testing set (n = 213). Prediction models for in-hospital
mortality were obtained using five supervised machine-learning
classifiers. <br/>Result(s): A total of 849 TMVRs were analyzed in our
study. The overall in-hospital mortality was 3.1%. A naive Bayes (NB)
model had the best discrimination for fifteen variables, with an area
under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80-0.87),
compared to 0.77 for logistic regression (95% CI, 0.58-0.95), 0.73 for an
artificial neural network (95% CI, 0.55-0.91), and 0.67 for both a random
forest and a support-vector machine (95% CI, 0.47-0.87). History of
coronary artery disease, of chronic kidney disease, and smoking were the
three most significant predictors of in-hospital mortality.
<br/>Conclusion(s): We developed a robust machine-learning-derived model
to predict in-hospital mortality in patients undergoing TMVR. This model
is promising for decision-making and deserves further clinical
validation.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<43>
Accession Number
632910380
Title
Which preoperative screening tool should be applied to older patients
undergoing elective surgery to predict short-term postoperative outcomes?
Lessons from systematic reviews, meta-analyses and guidelines: heart and
non-cardiac surgery need a different approach?.
Source
Internal and emergency medicine. 16 (1) (pp 15-17), 2021. Date of
Publication: 01 Jan 2021.
Author
Rostagno C.
Institution
(Rostagno) Dipartimento Medicina Sperimentale e Clinica, Universita di
Firenze, Viale Morgagni 85, Firenze 50134, Italy
Publisher
NLM (Medline)

<44>
[Use Link to view the full text]
Accession Number
634121729
Title
A meta-analysis of the diagnostic accuracy of chest ultrasound for the
diagnosis of occult penetrating cardiac injuries in hemodynamically stable
patients with penetrating thoracic trauma.
Source
The journal of trauma and acute care surgery. 90 (2) (pp 388-395), 2021.
Date of Publication: 01 Feb 2021.
Author
Manzano-Nunez R.; Gomez A.; Espitia D.; Sierra-Ruiz M.; Gonzalez J.;
Rodriguez-Narvaez J.G.; Castillo A.C.; Gonzalez A.; Orjuela J.;
Orozco-Martin V.; Bernal F.; Giron F.; Rios A.C.; Carranza P.;
Gonzalez-Hadad A.; Garcia-Perdomo H.A.; Garcia A.F.
Institution
(Manzano-Nunez) From the Mederi Hospital Universitario Mayor (R.M.-N.,
D.E., J.G., J.G.R.-N., A.C.C., A.G., J.O., V.O.-M., F.B., F.G.); Escuela
de Medicina y Ciencias de la Salud (R.M.-N., D.E., J.G., J.G.R.-N.,
A.C.C., A.G., J.O., V.O.-M., F.B., F.G.), Universidad del Rosario, Bogota,
DC; Fundacion Valle del Lili, Clinical Research Center (A.G., M.S.-R.),
Cali; Hospital Occidente de Kennedy (A.C.R., P.C.), Bogota, DC; Seccion de
Urologia, Departamento de Cirugia, (A.G.-H., H.A.G.-P.), Universidad del
Valle; and Department of Surgery (A.F.G.), Fundacion Valle del Lili, Cali,
Colombia
Publisher
NLM (Medline)
Abstract
BACKGROUND: We performed a systematic review (SR) and meta-analysis (MA)
to determine the diagnostic accuracy of chest ultrasound (US) compared
with a pericardial window (PW) for the diagnosis of occult penetrating
cardiac injuries in hemodynamically stable patients with penetrating
thoracic trauma. <br/>METHOD(S): A literature search in five databases
identified relevant articles for inclusion in this SR and MA. Studies were
eligible if they evaluated the diagnostic accuracy of chest US, compared
with a PW, for the diagnosis of occult penetrating cardiac injuries in
hemodynamically stable patients presenting with penetrating thoracic
trauma. Two investigators independently assessed articles for inclusion
and exclusion criteria and selected studies for final analysis.
Methodological quality was evaluated using Quality Assessment of
Diagnostic Accuracy Studies-2. We performed a MA of binary diagnostic test
accuracy within the bivariate mixed-effects logistic regression modeling
framework. <br/>RESULT(S): We included five studies in our SR and MA.
These studies included a total of 556 trauma patients. The MA found that,
compared with PW, the US was 79% sensitive and 92% specific for detecting
occult penetrating cardiac injuries in hemodynamically stable patients.
The presence of a concomitant left hemothorax was frequent in patients
with false-negative results. <br/>CONCLUSION(S): This SR and MA found
that, compared with PW, US was 79% sensitive and 92% specific for
detecting occult penetrating cardiac injuries in hemodynamically stable
patients with penetrating thoracic trauma. Caution interpretation of
pericardial US results is suggested in the presence of left hemothorax. In
these cases, a second diagnostic test should be performed. LEVEL OF
EVIDENCE: Systematic Review and Meta-analysis, level II.<br/>Copyright
&#xa9; 2021 Wolters Kluwer Health, Inc. All rights reserved.

<45>
Accession Number
634120954
Title
Clinical effectiveness of therapy with continuous-flow left ventricular
assist devices in nonischemic versus ischemic cardiomyopathy: a systematic
review and meta-analysis.
Source
Canadian journal of surgery. Journal canadien de chirurgie. 64 (1) (pp
E39-E47), 2021. Date of Publication: 26 Jan 2021.
Author
Wavell C.; Sokolowski A.; Klingel M.L.; Yin C.; Nagpal A.D.
Institution
(Wavell, Sokolowski, Klingel, Yin, Nagpal) From the Division of Cardiac
Surgery, Department of Surgery, Schulich School of Medicine and Dentistry,
Western University, London, Ont. (Wavell, Sokolowski, Yin); The Hospital
for Sick Children, Toronto, Ont. (Klingel); Department of Microbiology and
Immunology, Schulich School of Medicine and Dentistry, Western University,
London, Ont. (Yin); and the Division of Critical Care Medicine, Department
of Medicine, Schulich School of Medicine and Dentistry, Western
University, London, Ont. (Nagpal)
Publisher
NLM (Medline)
Abstract
Background: Clinicians may be less inclined to consider long-term left
ventricular assist device (LVAD) therapy in end-stage heart failure (ESHF)
as a result of nonischemic cardiomyopathy (NICM) versus ischemic
cardiomyopathy (ICM) owing to potentially greater right ventricular
involvement in the former; however, it is unknown whether the cause of
heart failure has a clinically meaningful effect on outcomes following
LVAD implantation. In this systematic review, we aimed to determine
whether ischemic versus nonischemic etiology has any impact on
patient-relevant outcomes. <br/>Method(s): We searched MEDLINE, Embase,
PubMed and the Cochrane Library for studies published in English between
Jan. 1, 2000, and Nov. 22, 2018, that examined survival and
transplantation rates following LVAD implantation in patients with NICM or
ICM. Randomized clinical trials, cohort studies, case-control studies,
cross-sectional studies and case series with a sample size of at least 8
patients were eligible for inclusion. To be included in the meta-analysis,
outcomes had to include at least death reported at 30 days or 1 year after
LVAD implantation. Quality of included studies was assessed by 2
independent reviewers using the Newcastle-Ottawa Quality Assessment Scale
for Cohort Studies. The Grading of Recommendations Assessment, Development
and Evaluation (GRADE) quality-assessment tool was used to assess outcomes
(30-d survival, 1-yr survival and cardiac transplantation following LVAD
therapy) across studies. <br/>Result(s): From a total of 2843 citations
identified, 7 studies met all inclusion criteria. Studies were generally
of good quality, but reporting of patient demographic characteristics,
outcomes and complications was heterogeneous. We found no significant
difference in 30-day or 1-year survival or in cardiac transplantation
rates after device implantation between the NICM and ICM groups. Patients
in the 2 groups had similar outcomes up to 1 year with LVAD therapy.
<br/>Conclusion(s): Early outcomes of LVAD therapy do not appear to be
affected by heart failure etiology. Ongoing investigation is required to
determine the long-term outcomes of LVAD therapy in ICM and NICM.
Systematic review registration: PROSPERO register, record ID
76483.<br/>Copyright &#xa9; 2021 Joule Inc. or its licensors.

<46>
Accession Number
2005958128
Title
Role of cachexia and fragility in the patient candidate for cardiac
surgery.
Source
Nutrients. 13 (2) (pp 1-17), 2021. Article Number: 517. Date of
Publication: February 2021.
Author
Pisano C.; Polisano D.; Balistreri C.R.; Altieri C.; Nardi P.; Bertoldo
F.; Trombetti D.; Asta L.; Ferrante M.S.; Buioni D.; Foti C.; Ruvolo G.
Institution
(Pisano, Altieri, Nardi, Bertoldo, Trombetti, Asta, Ferrante, Buioni,
Ruvolo) Department of Cardiac Surgery, Tor Vergata University Hospital,
Rome 00133, Italy
(Polisano, Foti) Physical and Rehabilitation Medicine, Tor Vergata
University of Rome, Rome 00133, Italy
(Balistreri) Department of Biomedicine, Neuroscience and Advanced
Diagnostics (Bi.N.D.), University of Palermo, Palermo 90133, Italy
Publisher
MDPI AG
Abstract
Frailty is the major expression of accelerated aging and describes a
decreased resistance to stressors, and consequently an increased
vulnerability to additional diseases in elderly people. The vascular aging
related to frail phenotype reflects the high susceptibility for
cardiovascular diseases and negative postoperative outcomes after cardiac
surgery. Sarcopenia can be considered a biological substrate of physical
frailty. Malnutrition and physical inactivity play a key role in the
pathogenesis of sarcopenia. We searched on Medline (PubMed) and Scopus for
relevant literature published over the last 10 years and analyzed the
strong correlation between frailty, sarcopenia and cardiovascular diseases
in elderly patient. In our opinion, a right food intake and moderate
intensity resistance exercise are mandatory in order to better prepare
patients undergoing cardiac operation.<br/>Copyright &#xa9; 2021 by the
authors. Licensee MDPI, Basel, Switzerland.

<47>
Accession Number
2010925016
Title
Treatment of acute cardiac tamponade: A retrospective analysis of
classical intermittent versus continuous pericardial drainage.
Source
IJC Heart and Vasculature. 32 (no pagination), 2021. Article Number:
100722. Date of Publication: February 2021.
Author
Stremmel C.; Scherer C.; Lusebrink E.; Kupka D.; Schmid T.; Stocker T.;
Kellnar A.; Kleeberger J.; Sinner M.F.; Petzold T.; Mehilli J.; Braun D.;
Hausleiter J.; Massberg S.; Orban M.
Institution
(Stremmel, Scherer, Lusebrink, Kupka, Schmid, Stocker, Kellnar,
Kleeberger, Sinner, Petzold, Braun, Orban, Hausleiter, Massberg, Orban)
Medizinische Klinik und Poliklinik I, Klinikum der Universitat Munchen,
Munich, Germany
(Stremmel, Scherer, Lusebrink, Kupka, Schmid, Stocker, Kellnar,
Kleeberger, Sinner, Petzold, Mehilli, Braun, Orban, Hausleiter, Massberg,
Orban) DZHK (German Centre for Cardiovascular Research), partner site
Munich Heart Alliance, Klinikum der Universitat Munchen, Munich, Germany
(Mehilli) Medizinische Klinik I, Krankenhaus Landshut-Achdorf, Landshut,
Germany
Publisher
Elsevier Ireland Ltd
Abstract
Background: Acute cardiac tamponade is a life-threatening pathology in
modern cardiology as catheter-based interventions become increasingly
relevant. Pericardiocentesis is usually the primary treatment of choice.
However, protocols for handling of draining pigtail catheters are very
variable due to limit data and require further investigation.
<br/>Method(s): We retrospectively analyzed 52 patients with acute cardiac
tamponade requiring immediate pericardiocentesis from January 2017 to
August 2020. Patients were treated with a classical approach of
intermittent manual aspiration or continuous pericardial drainage using a
redon drainage system. <br/>Result(s): Mean age of patients was 74 years
in both groups. Most common causes for cardiac tamponade were percutaneous
coronary interventions in about 50% and transaortic valve implantations in
25% of all cases. 28 patients were treated with classic intermittent
drainage from 2017 to 2020. 24 patients were treated with continuous
drainage from December 2018-2020. Compared to classical intermittent
drainage treatment, continuous drainage was associated with a lower rate
of a surgical intervention or cardiac re-tamponade and a lower mortality
at 5 days (HR 0.2, 95% CI 0.1-0.9, log-rank p = 0.03). Despite a longer
total drainage time under continuous suction, drainage volumes were
comparable in both groups. <br/>Conclusion(s): Acute cardiac tamponade can
be efficiently treated by pericardiocentesis with subsequent continuous
negative pressure drainage via a pigtail catheter. Our retrospective
analysis shows a significantly lower mortality, a decreased rate of
interventions and lower rates of cardiac re-tamponade without any relevant
side effects when compared to classical intermittent manual drainage.
These findings require further investigations in larger, randomized
trials.<br/>Copyright &#xa9; 2021 The Authors

<48>
Accession Number
2005875485
Title
Early aspirin discontinuation after coronary stenting: A systematic review
and meta-analysis.
Source
Journal of the American Heart Association. 10 (2) (pp 1-10), 2021. Article
Number: e018304. Date of Publication: 2021.
Author
Wiebe J.; Ndrepepa G.; Kufner S.; Lahmann A.L.; Xhepa E.; Kuna C.; Voll
F.; Gosetti R.; Laugwitz K.-L.; Joner M.; Kastrati A.; Cassese S.
Institution
(Wiebe, Ndrepepa, Kufner, Lahmann, Xhepa, Kuna, Voll, Joner, Kastrati,
Cassese) Klinik fur Herz- und Kreislauferkrankungen, Deutsches Herzzentrum
Munchen, Technische Universitat Munchen, Munich, Germany
(Gosetti, Laugwitz) Medizinische Klinik, Klinikum rechts der Isar,
Technische Universitat Munchen, Munich, Germany
(Laugwitz, Joner, Kastrati) DZHK (German Centre for Cardiovascular
Research), partner site Munich Heart Alliance, Munich, Germany
Publisher
American Heart Association Inc.
Abstract
BACKGROUND: The clinical impact of early aspirin discontinuation compared
with dual antiplatelet therapy (DAPT) in patients undergoing percutaneous
coronary intervention with stenting remains poorly studied. We
investigated the clinical outcomes of patients assigned to either early
aspirin discontinuation or DAPT after percutaneous coronary intervention
with stenting. METHODS AND RESULTS: We performed a meta-analysis of
aggregate data from randomized clinical trials enrolling participants
receiving a percutaneous coronary intervention with stenting and assigned
to either early aspirin discontinuation or DAPT. Scientific databases were
searched from inception through March 30, 2020. Trial-level hazard ratios
(HRs) and 95% CIs were pooled using a random effects model with inverse
variance weighting. The primary outcome was all-cause death. Secondary
outcomes were myocardial infarction, stent thrombosis, stroke, and major
bleeding. Overall, 36 206 participants were allocated to either early
aspirin discontinuation (experimental therapy, n=18 088) or DAPT (control
therapy, n=18 118) in 7 trials. Median follow-up was 12 months. All-cause
death occurred in 2.5% of patients assigned to experimental and 2.9% of
patients assigned control therapy (hazard ratio [HR], 0.91, 95% CI,
0.75-1.11; P=0.37). Overall, patients treated with experimental versus
control therapy showed no significant difference in terms of myocardial
infarction (HR, 1.02 [0.85-1.22], P=0.81), stent thrombosis (HR, 1.02
[0.87-1.20], P=0.83), or stroke (HR, 1.01 [0.68-1.49], P=0.96). However,
the risk for major bleeding (HR, 0.58 [0.43-0.77], P<0.01) was
significantly reduced by experimental as compared with control therapy.
<br/>CONCLUSION(S): In patients treated with percutaneous coronary
intervention and stenting, assigned to a strategy of early aspirin
discontinuation versus DAPT, the risk of death and ischemic events is not
significantly different but the risk of bleeding is lower.<br/>Copyright
&#xa9; 2021 The Authors.

<49>
Accession Number
2005967851
Title
Probucol trial for secondary prevention of atherosclerotic events in
patients with coronary heart disease (Prospective).
Source
Journal of Atherosclerosis and Thrombosis. 28 (2) (pp 103-123), 2021. Date
of Publication: 2021.
Author
Yamashita S.; Arai H.; Bujo H.; Masuda D.; Ohama T.; Ishibashi T.; Yanagi
K.; Doi Y.; Nakagawa S.; Yamashiro K.; Tanabe K.; Kita T.; Matsuzaki M.;
Saito Y.; Fukushima M.; Matsuzawa Y.
Institution
(Yamashita, Masuda, Ohama) Department of Cardiovascular Medicine, Osaka
University Graduate School of Medicine, Osaka, Suita, Japan
(Yamashita) Department of Community Medicine, Osaka University Graduate
School of Medicine, Osaka, Suita, Japan
(Arai) The National Center for Geriatrics and Gerontology, Aichi, Obu,
Japan
(Bujo) Department of Clinical Laboratory and Experimental Research
Medicine, Toho University, Sakura Medical Center, Chiba, Sakura, Japan
(Ohama) Department of Dental Anesthesiology, Osaka University Graduate
School of Dentistry, Osaka, Suita, Japan
(Ishibashi) Ohara General Hospital, Fukushima, Fukushima, Japan
(Yanagi) Kenporen Osaka Central Hospital, Osaka, Japan
(Doi) Saiseikai Senri Hospital, Osaka, Suita, Japan
(Nakagawa, Yamashiro, Tanabe, Fukushima) Translational Research Center for
Medical Innovation, Foundation for Biomedical Research and Innovation at
Kobe, Hyogo, Kobe, Japan
(Kita) Kobe City College of Nursing, Hyogo, Kobe, Japan
(Matsuzaki) St. Hill Hospital, Yamaguchi, Ube, Japan
(Saito) Chiba University Graduate School of Medicine, Chiba, Japan
(Matsuzawa) Sumitomo Hospital, Osaka, Japan
Publisher
Japan Atherosclerosis Society
Abstract
Aims: Although intensive statin therapy reduced cardiovascular risks,
cardiovascular events have not been com-pletely prevented. Probucol is a
potent antioxidant and reduces tendon xanthomas in familial
hypercholesterol-emia patients despite reduction of high-density
lipoprotein (HDL)-cholesterol (HDL-C). We investigated whether probucol
can reduce cardiovascular events on top of conventional lipid-lowering
therapy in patients with coronary heart disease (CHD). <br/>Method(s):
PROSPECTIVE is a multicenter, randomized, prospective study that recruited
876 Japanese patients with CHD and dyslipidemia with a low-density
lipoprotein (LDL)-cholesterol (LDL-C) level of >= 140 mg/dL without
medication or those treated with lipid-lowering drugs. Lipid-lowering
agents were administered during the study period in the control group (n
=438), and probucol 500 mg/day was added to lipid-lowering therapy in the
probucol group (n =438). Patients were randomly assigned to two treatment
groups by adjusting the LDL-C level and presence of diabetes and
hypertension and followed up for more than 3 years. The primary end point
was a composite of cerebrovascular and cardiovascular events
(cardiovascular disease death including sudden death, nonfatal myocardial
infarction, nonfatal stroke, hospitalization for unstable angina,
hospitalization for heart failure, or coronary revascularization). The
secondary end point was carotid intima-media thickness in a subset of
patients. <br/>Result(s): The incidence of the primary end point showed a
trend to be lower in the probucol group compared with that in the control
group despite reduced HDL-C without serious adverse events.
Anti-atherogenic effects of probucol may be attributed to its potent
antioxidative function and enhancement of reverse cholesterol transport.
<br/>Conclusion(s): Since there was no statistical significance between
the probucol and control groups despite a marked reduction of HDL-C,
further studies on the clinical outcomes of probucol on top of
conventional therapy may be necessary in the future
(UMIN000003307).<br/>Copyright &#xa9; 2021 Japan Atherosclerosis Society.

<50>
Accession Number
2010920415
Title
Mortality in patients with cardiogenic shock supported with VA ECMO: A
systematic review and meta-analysis evaluating the impact of etiology on
29,289 patients.
Source
Journal of Heart and Lung Transplantation. (no pagination), 2021. Date of
Publication: 2021.
Author
Alba A.C.; Foroutan F.; Buchan T.A.; Alvarez J.; Kinsella A.; Clark K.;
Zhu A.; Lau K.; McGuinty C.; Aleksova N.; Francis T.; Stanimirovic A.;
Vishram-Nielsen J.; Malik A.; Ross H.J.; Fan E.; Rac V.E.; Rao V.; Billia
F.
Institution
(Alba, Foroutan, Buchan, Alvarez, Kinsella, Clark, Zhu, Lau, McGuinty,
Aleksova, Vishram-Nielsen, Malik, Ross, Rac, Rao, Billia) Ted Rogers
Center of Excellence, Peter Munk Cardiac Centre, Toronto, ON, Canada
(Francis, Stanimirovic) Toronto Health Economics and Technology Assessment
(THETA) Collaborative, Institute of Health Policy, Management and
Evaluation, Dalla Lana School of Public Health
(Fan) Interdepartmental Division of Critical Care Medicine, University of
Toronto, Toronto, ON, Canada
Publisher
Elsevier Inc.
Abstract
BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA ECMO) is
associated with variable outcomes. In this meta-analysis, we evaluated the
mortality after VA ECMO across multiple etiologies of cardiogenic shock
(CS). <br/>METHOD(S): In June 2019, we performed a systematic search
selecting observational studies with >=10 adult patients reporting on
short-term mortality (30-day or mortality at discharge) after initiation
of VA ECMO by CS etiology published after 2009. We performed meta-analyses
using random effect models and used metaregression to evaluate mortality
across CS etiology. <br/>RESULT(S): We included 306 studies (29,289
patients): 25 studies on after heart transplantation (HTx) (771 patients),
13 on myocarditis (906 patients), 33 on decompensated heart failure (HF)
(3,567 patients), 64 on after cardiotomy shock (8,231 patients), 10 on
pulmonary embolism (PE) (221 patients), 80 on acute myocardial infarction
(AMI) (7,774 patients), and 113 on after cardiac arrest [CA] (7,814
patients). With moderate certainty on effect estimates, we observed
significantly different mortality estimates for various etiologies (p <
0.001), which is not explained by differences in age and sex across
studies: 35% (95% CI: 29-42) for after HTx, 40% (95% CI: 33-46) for
myocarditis, 53% (95% CI: 46-59) for HF, 52% (95% CI: 38-66) for PE, 59%
(95% CI: 56-63) for cardiotomy, 60% (95% CI: 57-64) for AMI, 64% (95% CI:
59-69) for post-in-hospital CA, and 76% (95% CI: 69-82) for
post-out-of-hospital CA. Univariable metaregression showed that variation
in mortality estimates within etiology group was partially explained by
population age, proportion of females, left ventricle venting, and CA.
<br/>CONCLUSION(S): Using an overall estimate of mortality for patients
with CS requiring VA ECMO is inadequate given the differential outcomes by
etiology. To further refine patient selection and management to improve
outcomes, additional studies evaluating patient characteristics impacting
outcomes by specific CS etiology are needed.<br/>Copyright &#xa9; 2021
International Society for Heart and Lung Transplantation

<51>
Accession Number
2005894031
Title
Symptomatic isolated internal carotid artery occlusion with initial
medical management: a monocentric cohort.
Source
Journal of Neurology. 268 (1) (pp 346-355), 2021. Date of Publication:
January 2021.
Author
Ter Schiphorst A.; Gaillard N.; Dargazanli C.; Mourand I.; Corti L.;
Charif M.; Ayrignac X.; Lippi A.; Bouly S.; Thibault L.; Sablot D.;
Blanchet-Fourcade G.; Landragin N.; Costalat V.; Duflos C.; Arquizan C.
Institution
(Ter Schiphorst, Gaillard, Mourand, Corti, Charif, Ayrignac, Lippi,
Arquizan) Department of Neurology, CHRU Gui de Chauliac, 80 Avenue
Augustin Fliche, Montpellier 34295, France
(Dargazanli, Costalat) Department of Neuroradiology, CHRU Gui de Chauliac,
Montpellier, France
(Bouly) Department of Neurology, CHRU Caremeau, Nimes, France
(Thibault) Department of Neurology, CH de Beziers, Beziers, France
(Sablot) Department of Neurology, CH de Perpignan, Perpignan, France
(Blanchet-Fourcade) Department of Neurology, CH de Narbonne, Narbonne,
France
(Landragin) Department of Neurology, Clinique du Millenaire, Montpellier,
France
(Duflos) Clinical Research and Epidemiology Unit, CHU, University
Montpellier, Montpellier, France
Publisher
Springer Science and Business Media Deutschland GmbH
Abstract
Background: Symptomatic isolated carotid artery occlusions (ICAO) can lead
to disability, recurrent stroke, and mortality, but natural history and
best therapeutic management remain poorly known. The objective of this
study was to describe our cohort of ICAO patients with an initial medical
management. <br/>Method(s): We conducted a retrospective study including
consecutive patients admitted to our Comprehensive Stroke Center for ICAO
within 24 h after stroke onset between January 2016 and September 2018.
Patients with immediate endovascular therapy (EVT) were excluded. Medical
treatment was based on anticoagulation (delayed by 24 h if intravenous
thrombolysis was performed). 'Rescue' EVT was considered if first-week
neurological deterioration (FWND) occurred. <br/>Result(s): Fifty-six
patients were included, with a median National Institutes of Health Stroke
Scale (NIHSS) of 3. Eleven patients (20%) had FWND during the first week,
four benefited from rescue EVT. A mismatch volume > 40 cc on initial
perfusion imaging and FLAIR vascular hyperintensities were associated with
FWND (p = 0.007 and p = 0.009, respectively). Thirty-eight patients (69%)
had a good outcome (modified Rankin Scale mRS 0-2) at 3 months, 36 (69%)
had an excellent outcome (mRS 0-1). Seventeen patients (38%) had carotid
patency on 3-month control imaging. Recurrences occurred in six (13%) of
the survivors (mean follow-up: 13.6 months). <br/>Conclusion(s): Our
results suggest that the prognosis of patients with acute ICAO was
favorable with a medical strategy, albeit a substantial rate of FWND and
recurrence. FWND was well predicted by a core-perfusion mismatch volume >
40 cc. Randomized controlled trials are necessary to assess the benefit of
EVT in ICAO.<br/>Copyright &#xa9; 2020, Springer-Verlag GmbH Germany, part
of Springer Nature.

<52>
Accession Number
2005781545
Title
Sarcopenia in Patients Undergoing Transcatheter Aortic Valve Implantation
(TAVI): A Systematic Review of the Literature.
Source
Journal of Nutrition, Health and Aging. 25 (1) (pp 64-70), 2021. Date of
Publication: January 2021.
Author
Bertschi D.; Kiss C.M.; Schoenenberger A.W.; Stuck A.E.; Kressig R.W.
Institution
(Bertschi, Kiss, Kressig) University Department of Geriatric Medicine
FELIX PLATTER, Burgfelderstrasse 101, Basel 4055, Switzerland
(Bertschi, Schoenenberger, Stuck) Department of Geriatrics, Inselspital,
Bern University Hospital, and University of Bern, Bern, Switzerland
Publisher
Serdi-Editions
Abstract
Background: In older patients, sarcopenia is a prevalent disease
associated with negative outcomes. Sarcopenia has been investigated in
patients undergoing transcatheter aortic valve implantation (TAVI), but
the criteria for diagnosis of the disease are heterogeneous. This
systematic review of the current literature aims to evaluate the
prevalence of sarcopenia in patients undergoing TAVI and to analyse the
impact of sarcopenia on clinical outcomes. <br/>Method(s): A comprehensive
search of the literature has been performed in electronic databases from
the date of initiation until March 2020. Using a pre-defined search
strategy, we identified studies assessing skeletal muscle mass, muscle
quality and muscle function as measures for sarcopenia in patients
undergoing TAVI. We evaluated how sarcopenia affects the outcomes
mortality at >=1 year, prolonged length of hospital stay, and functional
decline. <br/>Result(s): We identified 18 observational studies, enrolling
a total number of 9'513 patients. For assessment of skeletal muscle mass,
all included studies used data from computed tomography. Cutoff points for
definition of low muscle mass were heterogeneous, and prevalence of
sarcopenia varied between 21.0% and 70.2%. In uni- or multivariate
regression analysis of different studies, low muscle mass was found to be
a significant predictor of mortality, prolonged length of hospital stay,
and functional decline. No interventional study was identified measuring
the effect of nutritional or physiotherapy interventions on sarcopenia in
TAVI patients. <br/>Conclusion(s): Sarcopenia is highly prevalent among
patients undergoing TAVI, and negatively affects important outcomes. Early
diagnosis of this condition might allow a timely start of nutritional and
physiotherapy interventions to prevent negative outcomes in TAVI
patients.<br/>Copyright &#xa9; 2020, Serdi and Springer-Verlag
International SAS, part of Springer Nature.

<53>
Accession Number
631404242
Title
Implementation of appropriate use criteria for cardiology tests and
procedures: a systematic review and meta-analysis.
Source
European heart journal. Quality of care & clinical outcomes. 7 (1) (pp
34-41), 2021. Date of Publication: 25 Jan 2021.
Author
Winchester D.E.; Merritt J.; Waheed N.; Norton H.; Manja V.; Shah N.R.;
Helfrich C.D.
Institution
(Winchester) Cardiology Section, Malcom Randall VAMC, 1601 SW Archer Rd
111-D, FL, Gainesville, United States
(Winchester, Merritt) Division of Cardiovascular Medicine, University of
Florida College of Medicine, FL 32610, 1600 SW Archer Rd, Gainesville,
United States
(Waheed) Department of Internal Medicine, University of Florida College of
Medicine, FL 32610, 1600 SW Archer Rd, Gainesville, United States
(Norton) University of Florida College of Medicine, Health Science Center
Library, FL 32610, 1600 SW Archer Rd, Gainesville, United States
(Manja) Department of Surgery, University of California Davis, 2315
Stockton Blvd, Sacramento, CA 95817, USA
(Manja) VA Northern California Health Care System, 10535 Hospital Way,
Mather, CA 95655, USA
(Shah) Department of Medicine, Providence VA Medical Center, Brown
University Warren Alpert Medical School, 830 Chalkstone Ave, Providence,
RI 02908, USA
(Shah) Department of Health Services, Policy & Practice, Brown University
School of Public Health, 121 S Main St, Providence, RI 02903, USA
(Helfrich) Seattle-Denver Center for Innovation in Veteran-Centered and
Value-Driven Care, 1660 S. Columbian Way Mailstop S-152 Seattle, WA 98108,
United States
Publisher
NLM (Medline)
Abstract
AIMS: The American College of Cardiology appropriate use criteria (AUC)
provide clinicians with evidence-informed recommendations for cardiac
care. Adopting AUC into clinical workflows may present challenges, and
there may be specific implementation strategies that are effective in
promoting effective use of AUC. We sought to assess the effect of
implementing AUC in clinical practice. METHODS AND RESULTS: We conducted a
meta-analysis of studies found through a systematic search of the MEDLINE,
Web of Science, Cochrane, or CINAHL databases. Peer-reviewed manuscripts
published after 2005 that reported on the implementation of AUC for a
cardiovascular test or procedure were included. The main outcome was to
determine if AUC implementation was associated with a reduction in
inappropriate/rarely appropriate care. Of the 18 included studies, the
majority used pre/post-cohort designs; few (n=3) were randomized trials.
Most studies used multiple strategies (n=12, 66.7%). Education was the
most common individual intervention strategy (n=13, 72.2%), followed by
audit and feedback (n=8, 44.4%) and computerized physician order entry
(n=6, 33.3%). No studies reported on formal use of stakeholder engagement
or 'nudges'. In meta-analysis, AUC implementation was associated with a
reduction in inappropriate/rarely appropriate care (odds ratio 0.62, 95%
confidence interval 0.49-0.78). Funnel plot suggests the possibility of
publication bias. <br/>CONCLUSION(S): We found most published efforts to
implement AUC observed reductions in inappropriate/rarely appropriate
care. Studies rarely explored how or why the implementation strategy was
effective. Because interventions were infrequently tested in isolation, it
is difficult to make observations about their effectiveness as stand-alone
strategies. STUDY REGISTRATION: PROSPERO 2018 CRD42018091602. Available
from
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018091602.<
br/>Copyright Published by Oxford University Press on behalf of the
European Society of Cardiology 2020.

<54>
[Use Link to view the full text]
Accession Number
633805972
Title
Exposure-Response Relationship of Tranexamic Acid in Cardiac Surgery.
Source
Anesthesiology. 134 (2) (pp 165-178), 2021. Date of Publication: 01 Feb
2021.
Author
Zufferey P.J.; Lanoiselee J.; Graouch B.; Vieille B.; Delavenne X.; Ollier
E.
Publisher
NLM (Medline)
Abstract
BACKGROUND: It is unclear whether high-dose regimens of tranexamic acid in
cardiac surgery (total dose, 80 to 100 mg/kg) confer a clinical advantage
over low-dose regimens (total dose, approximately 20 mg/kg), particularly
as tranexamic acid-associated seizure may be dose-related. The authors'
aim was to characterize the exposure-response relationship of this drug.
<br/>METHOD(S): Databases were searched for randomized controlled trials
of intravenous tranexamic acid in adult patients undergoing
cardiopulmonary bypass surgery. Observational studies were added for
seizure assessment. Tranexamic acid concentrations were predicted in each
arm of each study using a population pharmacokinetic model. The
exposure-response relationship was evaluated by performing a model-based
meta-analysis using nonlinear mixed-effect models. <br/>RESULT(S):
Sixty-four randomized controlled trials and 18 observational studies
(49,817 patients) were included. Seventy-three different regimens of
tranexamic acid were identified, with the total dose administered ranging
from 5.5 mg/kg to 20 g. The maximum effect of tranexamic acid for
postoperative blood loss reduction was 40% (95% credible interval, 34 to
47%), and the EC50 was 5.6 mg/l (95% credible interval, 0.7 to 11 mg/l).
Exposure values with low-dose regimens approached the 80% effective
concentration, whereas with high-dose regimens, they exceeded the 90%
effective concentration. The predicted cumulative blood loss up to 48 h
postsurgery differed by 58 ml between the two regimens, and the absolute
difference in erythrocyte transfusion rate was 2%. Compared to no
tranexamic acid, low-dose and high-dose regimens increased the risk of
seizure by 1.2-fold and 2-fold, respectively. However, the absolute risk
increase was only clinically meaningful in the context of prolonged
open-chamber surgery. <br/>CONCLUSION(S): In cardiopulmonary bypass
surgery, low-dose tranexamic acid seems to be an appropriate regimen for
reducing bleeding outcomes. This meta-analysis has to be interpreted with
caution because the results are observational and dependent on the lack of
bias of the predicted tranexamic acid exposures and the quality of the
included studies.<br/>Copyright &#xa9; 2020, the American Society of
Anesthesiologists, Inc. All Rights Reserved.

<55>
Accession Number
633133634
Title
Video-Assisted Thoracoscopic or Conventional Thoracic Surgery in Infants
and Children: Current Evidence.
Source
European Journal of Pediatric Surgery. 31 (1) (pp 54-64), 2021. Date of
Publication: 01 Feb 2021.
Author
Kiblawi R.; Zoeller C.; Zanini A.; Ure B.M.; Dingemann J.; Kuebler J.F.;
Schukfeh N.
Institution
(Kiblawi, Zoeller, Ure, Dingemann, Kuebler, Schukfeh) Department of
Pediatric Surgery, Hannover Medical School, Carl-Neuberg-Strabetae 1,
Hannover, Niedersachsen 30625, Germany
(Zanini) Department of Pediatric Surgery, University of Witwatersrand,
Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa
Publisher
Georg Thieme Verlag
Abstract
Introduction The pros and cons of video-assisted thoracoscopic versus
conventional thoracic surgery in infants and children are still under
debate. We assessed reported advantages and disadvantages of
video-assisted thoracoscopy in pediatric surgical procedures, as well as
the evidence level of the available data. Materials and Methods A
systematic literature search was performed to identify manuscripts
comparing video-assisted thoracoscopic and the respective conventional
thoracic approach in classic operative indications of pediatric surgery.
Outcome parameters were analyzed and graded for level of evidence
(according to the Oxford Centre of Evidence-Based Medicine). Results A
total of 48 comparative studies reporting on 12,709 patients, 11
meta-analyses, and one pilot randomized controlled trial including 20
patients were identified. More than 15 different types of advantages for
video-assisted thoracoscopic surgery were described, mostly with a level
of evidence 3b or 3a. Most frequently video-assisted thoracoscopic surgery
was associated with shorter hospital stay, shorter postoperative
ventilation, and shorter time to chest drain removal. Mortality rate and
severe complications did not differ between thoracoscopic and conventional
thoracic pediatric surgery, except for congenital diaphragmatic hernia
repair with a lower mortality and higher recurrence rate after
thoracoscopic repair. The most frequently reported disadvantage for
video-assisted thoracoscopic surgery was longer operative time. Conclusion
The available data point toward improved recovery in pediatric
video-assisted thoracoscopic surgery despite longer operative times.
Further randomized controlled trials are needed to justify the widespread
use of video assisted thoracoscopy in pediatric surgery.<br/>Copyright
&#xa9; 2021 Georg Thieme Verlag. All rights reserved.

<56>
Accession Number
2005609285
Title
A European consensus statement on the use of four-factor prothrombin
complex concentrate for cardiac and non-cardiac surgical patients.
Source
Anaesthesia. 76 (3) (pp 381-392), 2021. Date of Publication: March 2021.
Author
Erdoes G.; Koster A.; Ortmann E.; Meesters M.I.; Bolliger D.; Baryshnikova
E.; Martinez Lopez De Arroyabe B.; Ahmed A.; Lance M.D.; Ranucci M.; von
Heymann C.; Agarwal S.; Ravn H.B.
Institution
(Erdoes) Department of Anaesthesiology and Pain Medicine, Inselspital,
Bern University Hospital, University of Bern, Switzerland
(Koster) Institute for Anaesthesiology, Heart and Diabetes Centre NRW,
Ruhr-University Bochum, Bad Oeynhausen, Germany
(Ortmann) Department of Anaesthesia, Kerckhoff Heart and Lung Centre, Bad
Nauheim, Germany
(Meesters) Department of Anaesthesiology, University Medical Centre
Utrecht, Netherlands
(Bolliger) Department of Anaesthesia, Prehospital Emergency Medicine, and
Pain Therapy, University Hospital Basel, Switzerland
(Baryshnikova, Ranucci) Department of Cardiovascular Anaesthesia and
Intensive Care Unit, IRCCS Policlinico San Donato, San Donato Milanese,
Milan, Italy
(Martinez Lopez De Arroyabe) Department of Cardiac Anaesthesia and
Intensive Care, Ca`Foncello Hospital of Treviso, Treviso, Italy
(Ahmed) Department of Anaesthesia, University Hospitals of Leicester NHS
Trust, United Kingdom
(Ahmed) Department of Cardiovascular Sciences, University of Leicester,
United Kingdom
(Lance) Hamad Medical Corporation, HMC, Anaesthesiology, ICU and
Peri-operative Medicine, Doha, Qatar
(von Heymann) Department of Anaesthesia, Intensive Care Medicine,
Emergency Medicine and Pain Therapy, Vivantes Klinikum im Friedrichshain,
Berlin, Germany
(Agarwal) Department of Anaesthesia, Manchester University Hospitals,
Manchester, United Kingdom
(Ravn) Department of Cardiothoracic Anaesthesiology, Rigshospitalet,
Copenhagen University, Copenhagen, Denmark
Publisher
Blackwell Publishing Ltd
Abstract
Modern four-factor prothrombin complex concentrate was designed originally
for rapid targeted replacement of the coagulation factors II, VII, IX and
X. Dosing strategies for the approved indication of vitamin K
antagonist-related bleeding vary greatly. They include INR and
bodyweight-related protocols as well as fixed dose regimens. Particularly
in the massively bleeding trauma and cardiac surgery patient, four-factor
prothrombin complex concentrate is used increasingly for haemostatic
resuscitation. Members of the Transfusion and Haemostasis Subcommittee of
the European Association of Cardiothoracic Anaesthesiology performed a
systematic literature review on four-factor prothrombin complex
concentrate. The available evidence has been summarised for dosing,
efficacy, drug safety and monitoring strategies in different scenarios.
Whereas there is evidence for the efficacy of four-factor prothrombin
concentrate for a variety of bleeding scenarios, convincing safety data
are clearly missing. In the massively bleeding patient with coagulopathy,
our group recommends the administration of an initial bolus of 25
IU.kg^-1. This applies for: the acute reversal of vitamin K
antagonist therapy; haemostatic resuscitation, particularly in trauma; and
the reversal of direct oral anticoagulants when no specific antidote is
available. In patients with a high risk for thromboembolic complications,
e.g. cardiac surgery, the administration of an initial half-dose bolus
(12.5 IU.kg^-1) should be considered. A second bolus may be
indicated if coagulopathy and microvascular bleeding persists and other
reasons for bleeding are largely ruled out. Tissue-factor-activated,
factor VII-dependent and heparin insensitive point-of-care tests may be
used for peri-operative monitoring and guiding of prothrombin complex
concentrate therapy.<br/>Copyright &#xa9; 2020 Association of
Anaesthetists

<57>
Accession Number
2003583404
Title
Predicting mortality with cardiac troponins: Recent insights from
meta-analyses.
Source
Diagnosis. 8 (1) (no pagination), 2021. Date of Publication: 01 Feb 2021.
Author
Lippi G.; Cervellin G.; Sanchis-Gomar F.
Institution
(Lippi) Section of Clinical Biochemistry, University of Verona, Piazzale
LA Scuro, Verona 37134, Italy
(Cervellin) Emergency Department, University Hospital of Parma, Parma,
Italy
(Sanchis-Gomar) Department of Physiology, Faculty of Medicine, University
of Valencia, INCLIVA Biomedical Research Institute, Valencia, Spain
Publisher
Walter de Gruyter GmbH
Abstract
The introduction of cardiac troponin (cTn) testing in clinical practice
has been one of the most important breakthroughs that have occurred in the
recent history of laboratory medicine. Although it is now uncontestable
that cTn values are essential for diagnosing acute coronary syndrome
(ACS), solid evidence is also emerging that assessment of either cardiac
troponin I (cTnI) or T (cTnT) may provide valuable prognostic information
in the general healthy population, as well as in patients with a vast
array of cardiac and extra-cardiac diseases. We have hence performed a
critical review of the scientific literature for identifying meta-analyses
which have investigated the potential contribution of cTns in predicting
the risk of death in health and disease. According to the articles
identified with our research, we can conclude that increased cTn values
may be considered independent risk factors for all-cause mortality in the
general population, as well as in patients with ACS, in those undergoing
revascularization procedures, or with stable coronary artery disease
(CAD), heart failure (HF) and atrial fibrillation (AF). Measurement of cTn
may then be helpful for stratifying the mortality risk in non-cardiac
hospitalized patients, in those with critical illness or sepsis, syncope,
stroke, acute aortic dissection, pulmonary diseases, brain injury, renal
failure, vascular and non-cardiac surgery. Although this evidence has
notable clinical implications, the cost-effectiveness of population
screening with high-sensitivity (hs) cTn immunoassays has not been proven
so far.<br/>Copyright &#xa9; 2019 Walter de Gruyter GmbH, Berlin/Boston
2019.

<58>
Accession Number
634093241
Title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of
High-Dose, Short-Term Vitamin D Administration in the Prevention of Acute
Kidney Injury after Cardiac Surgery.
Source
CardioRenal Medicine. (no pagination), 2021. Date of Publication: 2021.
Author
Eslami P.; Hekmat M.; Beheshti M.; Baghaei R.; Mirhosseini S.M.;
Pourmotahari F.; Ziai S.A.; Foroughi M.
Institution
(Eslami, Hekmat, Beheshti, Baghaei, Mirhosseini, Pourmotahari, Ziai,
Foroughi) Cardiovascular Research Center, Shahid Beheshti University of
Medical Sciences, Saadat Abad, Tehran 19987 34383, Iran, Islamic Republic
of
Publisher
S. Karger AG
Abstract
Background: Acute kidney injury (AKI) after cardiac surgery is a
relatively common complication affecting short- and long-term survival.
The renoprotective effect of vitamin D (VitD) has been confirmed in
several experimental models. This study was conducted to evaluate the
effect of high-dose VitD administration in patients with VitD
insufficiency on the incidence of postoperative AKI, the urinary level of
tubular biomarkers, and serum anti-inflammatory biomarker after coronary
arterybypass graft. Design and Method: In this randomized double-blind
controlled clinical trial, the patients were randomly allocated to either
the VitD group (n = 50), receiving 150,000 IU VitD tablets daily for 3
consecutive days before surgery or the control group (n = 61), receiving
placebo tablets. <br/>Result(s): There was no difference in the incidence
of postoperative AKI between the groups. Both of the urinary levels of
interleukin-18 and kidney injury molecule-1 were significantly increased
after the operation (p < 0.001, for both). Also, the serum level of
interleukin-10 was increased after 3 days of VitD supplementation (p =
0.001). In comparison with the control group, it remainedon a higher level
after the operation (p < 0.001) and the next day (p = 0.03). The patients
withAKI had more postoperative bleeding and received more blood
transfusion. <br/>Conclusion(s): VitD pretreatment was unable to impose
any changes in the incidence of AKI and the urinary level of renal
biomarkers. However, high-dose administration of VitD may improve the
anti-inflammatory state before and after the operation. Further studies
are needed to assess the renoprotective effect of VitD on coronary surgery
patients. <br/>Copyright &#xa9; 2021 S. Karger AG, Basel.

<59>
[Use Link to view the full text]
Accession Number
633826469
Title
Intraoperative Oxygen Concentration and Neurocognition after Cardiac
Surgery.
Source
Anesthesiology. 134 (2) (pp 189-201), 2021. Date of Publication: 01 Feb
2021.
Author
Shaefi S.; Shankar P.; Mueller A.L.; O'Gara B.P.; Spear K.; Khabbaz K.R.;
Bagchi A.; Chu L.M.; Banner-Goodspeed V.; Leaf D.E.; Talmor D.S.;
Marcantonio E.R.; Subramaniam B.
Publisher
NLM (Medline)
Abstract
BACKGROUND: Despite evidence suggesting detrimental effects of
perioperative hyperoxia, hyperoxygenation remains commonplace in cardiac
surgery. Hyperoxygenation may increase oxidative damage and neuronal
injury leading to potential differences in postoperative neurocognition.
Therefore, this study tested the primary hypothesis that intraoperative
normoxia, as compared to hyperoxia, reduces postoperative cognitive
dysfunction in older patients having cardiac surgery. <br/>METHOD(S): A
randomized double-blind trial was conducted in patients aged 65 yr or
older having coronary artery bypass graft surgery with cardiopulmonary
bypass. A total of 100 patients were randomized to one of two
intraoperative oxygen delivery strategies. Normoxic patients (n = 50)
received a minimum fraction of inspired oxygen of 0.35 to maintain a Pao2
above 70 mmHg before and after cardiopulmonary bypass and between 100 and
150 mmHg during cardiopulmonary bypass. Hyperoxic patients (n = 50)
received a fraction of inspired oxygen of 1.0 throughout surgery,
irrespective of Pao2 levels. The primary outcome was neurocognitive
function measured on postoperative day 2 using the Telephonic Montreal
Cognitive Assessment. Secondary outcomes included neurocognitive function
at 1, 3, and 6 months, as well as postoperative delirium, mortality, and
durations of mechanical ventilation, intensive care unit stay, and
hospital stay. <br/>RESULT(S): The median age was 71 yr (interquartile
range, 68 to 75), and the median baseline neurocognitive score was 17 (16
to 19). The median intraoperative Pao2 was 309 (285 to 352) mmHg in the
hyperoxia group and 153 (133 to 168) mmHg in the normoxia group (P <
0.001). The median Telephonic Montreal Cognitive Assessment score on
postoperative day 2 was 18 (16 to 20) in the hyperoxia group and 18 (14 to
20) in the normoxia group (P = 0.42). Neurocognitive function at 1, 3, and
6 months, as well as secondary outcomes, were not statistically different
between groups. <br/>CONCLUSION(S): In this randomized controlled trial,
intraoperative normoxia did not reduce postoperative cognitive dysfunction
when compared to intraoperative hyperoxia in older patients having cardiac
surgery. Although the optimal intraoperative oxygenation strategy remains
uncertain, the results indicate that intraoperative hyperoxia does not
worsen postoperative cognition after cardiac surgery.<br/>Copyright &#xa9;
2020, the American Society of Anesthesiologists, Inc. All Rights Reserved.

<60>
Accession Number
2006893055
Title
Ultrasound versus thoracoscopic-guided paravertebral block during
thoracotomy.
Source
Asian Cardiovascular and Thoracic Annals. 29 (2) (pp 98-104), 2021. Date
of Publication: February 2021.
Author
Hegazy M.A.; Awad G.; Abdellatif A.; Saleh M.E.; Sanad M.
Institution
(Hegazy) Department of Anesthesia and Intensive Care, Faculty of Medicine,
Mansoura University, Egypt
(Awad, Abdellatif, Saleh, Sanad) Department of Cardiothoracic Surgery,
Faculty of Medicine, Mansoura University, Egypt
Publisher
SAGE Publications Inc.
Abstract
Background: Paravertebral block can be performed with the aid of surgical
landmarks, ultrasound, or a thoracoscope. This study was designed to
compare ultrasound-guided paravertebral block with the thoracoscopic
technique. <br/>Method(s): This prospective randomized comparative study
included 40 adults scheduled for elective thoracic surgery. Study
participants were randomized to an ultrasound group or a thoracoscope
group. A catheter for paravertebral block was inserted prior to
thoracotomy with real-time ultrasound visualization in the ultrasound
group, and under thoracoscopic guidance in the thoracoscope group. Total
analgesic consumption, visual analogue pain score, technical difficulties,
and complications were compared between the 2 groups. <br/>Result(s):
Total analgesic consumption in the first 24 hours was less in the
ultrasound group than in the thoracoscope group (rescue intravenous
fentanyl 121.25 +/- 64.01 microg in the ultrasound group vs. 178.75 +/-
91.36 microg in the thoracoscope group; p = 0.027). Total paravertebral
bupivacaine consumption was 376.00 +/- 33.779 mg in the ultrasound group
and 471.50 +/- 64.341 mg in the thoracoscope group (p < 0.001). Technical
difficulties and complications in terms of time consumed during the
maneuver, more than one needle pass, and pleural puncture were
significantly lower in the ultrasound group than in the thoracoscope
group. <br/>Conclusion(s): Ultrasound-guided paravertebral catheter
insertion is more effective, technically easier, and safer than the
thoracoscope-assisted technique.<br/>Copyright &#xa9; The Author(s) 2020.

<61>
Accession Number
2007789947
Title
Ischemic functional mitral regurgitation: from pathophysiological concepts
to current treatment options. A systemic review for optimal strategy.
Source
General Thoracic and Cardiovascular Surgery. 69 (2) (pp 213-229), 2021.
Date of Publication: February 2021.
Author
Nappi F.; Nenna A.; Mihos C.; Spadaccio C.; Gentile F.; Chello M.; Matzui
Y.
Institution
(Nappi) Cardiac Surgery, Centre Cardiologique du Nord, 36 Rue des Moulins
Gemeaux, Saint-Denis 93200, France
(Nenna, Chello) Cardiovascular Surgery, Universita Campus Bio-Medico di
Roma, Rome, Italy
(Mihos) Echocardiography Laboratory, Columbia University, Mount Sinai
Heart Institute, Miami, United States
(Spadaccio) Cardiothoracic Surgery, Golden Jubilee National Hospital,
Glasgow, United Kingdom
(Gentile) Cardiovascular Disease Diagnostic Medical Center, Naples, Italy
(Matzui) Cardiovascular and Thoracic Surgery, Hokkaido University Graduate
School of Medicine, Sapporo, Japan
Publisher
Springer Japan
Abstract
Objective: The current treatment of ischemic functional mitral
regurgitation (FMR) remains debated due to differences in inclusion
criteria of randomized studies and baseline characteristics. Also, the
role of left ventricular pathophysiology and the role of subvalvular
apparatus have not been thoroughly investigated in recent literature.
<br/>Method(s): A literature search was performed from PubMed inception to
June 2020. <br/>Result(s): Novel concepts of pathophysiology, such as the
proportionate/disproportionate conceptual framework, the role of papillary
muscles and left ventricular dysfunction, the impact of myocardial
ischemia and revascularization, left ventricular remodeling, and the
effect of restrictive annuloplasty or subvalvular procedures have been
reviewed. <br/>Conclusion(s): The clinical benefits associated with the
use of MitraClip is more evident in patients with disproportionate FMR
with greater and sustained left ventricular reverse remodeling.
Importantly, in the absence of myocardial revascularization, expansion of
myocardial scar tissue and non-perfused areas of ischemic myocardium occur
with time, and this impact on outcomes with a longer follow-up period
cannot be quantified. In advanced phases of FMR, neither mitral ring
annuloplasty nor percutaneous therapies could significantly modify the
established pathoanatomic alterations.<br/>Copyright &#xa9; 2021, The
Japanese Association for Thoracic Surgery.

<62>
Accession Number
634125273
Title
Efficacy of intravenous dexmedetomidine as a hypotensive agent to reduce
intra-operative bleeding during functional endoscopic sinus surgery:
Experience in a tertiary healthcare centre.
Source
Anaesthesia. Conference: Winter Scientific Meeting of the Association of
Anaesthetists of Great Britain and Ireland, AAGBI WSM 2021. 76 (SUPPL 2)
(pp 132), 2021. Date of Publication: January 2021.
Author
Dawoodi S.; Zaidi A.
Institution
(Dawoodi) Masina Hospital, Mumbai, India
(Zaidi) Mahatma Gandhi Memorial Medical College, Indore, India
Publisher
Blackwell Publishing Ltd
Abstract
Excessive bleeding during functional endoscopic sinus surgery (FESS)
impedes surgical progress, prolongs the overall duration of surgery and is
associated with increased complication rates. The present study aimed to
evaluate the efficacy of dexmedetomidine as a hypotensive agent on the
incidence of bleeding, quality of the operative field, intra-operative
haemodynamics (heart rate and systolic and diastolic blood pressure),
postoperative nausea and the need for maintenance drugs and analgesics.
Methods A randomised, prospective, single-blinded study was undertaken of
86 patients,16-50 years at a tertiary healthcare centre in India from
2017-2019. Subjects were divided randomly into group D receiving
dexmedetomidine (n = 43) and group N receiving normal saline (n = 43).
Maintaining a similar anaesthetic protocol, group D received loading dose
of 1 mug.kg^-1 dexmedetomidine 10 min before induction while
group N received the same volume of normal saline. Ten parameters were
recorded: demographic characteristics, total operative time,
haemodynamics, incidence of bleeding (operative field visibility) as per
the Fromme Boezaart scale [1], amount of bleeding, dosage of maintenance
drugs required, need for analgesic post-surgery, incidence of
postoperative nausea and vomiting, awakening time (modified Aldrete's
score [2]) and the complication rates. An ENT surgeon graded the
visibility of the operative field. Results A relatively bloodless surgical
field was obtained in 90.6% patients of group D vs. 48.8% of group N.
Group D showed substantially better intra-operative haemodynamics with
lesser intra-operative bleeding and shorter operative time reducing
complication rates. The incidence of postoperative nausea and vomiting was
significantly reduced for group D with reduced requirement of analgesics
and maintenance drugs. An interesting finding to note in our study was the
recovery time. It was smooth, but slightly prolonged in group D.
Discussion Dexmedetomidine can be used as a safe and effective drug during
surgical procedures where controlled hypotension is desirable. It
demonstrates better intra-operative haemodynamic properties with lesser
blood loss along with a satisfactory surgical field quality, lesser total
operative time leading to lower complication rates.

<63>
Accession Number
2005914521
Title
IMPACT OF BARIATRIC SURGERY ON PATIENTS WITH ADVANCED HEART FAILURE
SUPPORTED BY LEFT VENTRICULAR ASSIST DEVICES: A SYSTEMATIC REVIEW AND
META-ANALYSIS.
Source
Gastroenterology. Conference: 2020 DDW. United States. 158 (6 Supplement
1) (pp S-1578-S-1579), 2020. Date of Publication: May 2020.
Author
Wander P.; Scatola A.; Popov V.
Publisher
W.B. Saunders
Abstract
Introduction: Body mass index (BMI) >35 kg/m2 is a contraindication for
heart transplantation in patients with end-stage heart failure. Studies
suggest that patients with advanced heart failure supported with left
ventricular assist devices (LVAD) can become eligible for transplant after
bariatric surgery (BS). <br/>Aim(s): To assess the impact of BS on heart
transplantation in patients with LVADs in a systematic review and
meta-analysis of the published data. <br/>Method(s): MEDLINE and Embase
were searched from inception through September 2019 with relevant MeSH
terms for "bariatric surgery," "heart transplant" and "left ventricular
assisted device."Extraction and quality assessment of studies was
performed independently by two authors. Inclusion criteria were
retrospective and prospective studies reporting cardiac transplant
outcomes after bariatric procedures in patients with LVADs,with > 3
patients percohort. Primary outcomes included pooled event rates(ER) and
95% confidence interval (95% CI) for eligibility and success of heart
transplant in LVAD patients after BS. Secondary outcomes included ER of
patients meeting BMI criteria(<35 kg/m2) for cardiac transplantation.
Random effects meta-analysis was used for all outcomes. Heterogeneity was
assessed with the I²statistic, with I²>50%
considered substantial heterogeneity. Publication bias was assessed with
funnel plot and Egger's test. <br/>Result(s): 46 citations were
identified; 9 retrospective or cross-sectional cohort studies including 86
subjects were analyzed. Average follow-up was 14.3 months (range 6-24
months), average age at time of procedure was 43.6 years (range 39 to 48
years) and 31% were female. Laparoscopic sleeve gastrectomy was performed
in 94.2% (84/86) of subjects, with the remaining undergoing Roux-en-Y
gastric bypass. Mean BMI at the time of bariatric procedure was 44.8 kg/m2
(range 43.6 - 47 kg/m2) and at last follow up was33.2 kg/m2 (range 31- 37
kg/m2). 32% of patients underwent successful heart transplant after
bariatric surgery, ER 0.32(95% CI 0.23,0.44), I²=0%,
Tau²=0%, 8 studies, 86 patients) and Egger's test=0.3. 55% of
patients were listed for heart transplant after bariatric surgery, ER
0.55(95% CI 0.43,0.66), I²=0%, Tau²=0%, 7 studies,
79 patients. 58% of subjects were able to achieve BMI <35 kg/m2, ER
0.58(95% CI 0.46, 0.69), I²=1.2%, Tau²=0.2%, 7
studies, 79 patients. 55% of subjects could not be listed due to not
fulfilling other listing criteria, ER 0.55(95% CI 0.42, 0.68),
I²=14.1%, Tau²=0.08%, 7 studies, 79 patients. There
was limited information provided on adverse events and mortality.
<br/>Conclusion(s): Bariatric surgery is an important treatment option for
patients with advanced heart failure supported with LVADs, allowing them
to become eligible for cardiac transplantation by achieving their target
BMI. More data to assess long-term outcomes and adverse events is needed.
[Table presented] [Figure presented]<br/>Copyright &#xa9; 2020 AGA
Institute

<64>
Accession Number
2008414201
Title
Redevelopment and validation of the SYNTAX score II to individualise
decision making between percutaneous and surgical revascularisation in
patients with complex coronary artery disease: secondary analysis of the
multicentre randomised controlled SYNTAXES trial with external cohort
validation.
Source
The Lancet. 396 (10260) (pp 1399-1412), 2020. Date of Publication: 31 Oct
2020.
Author
Takahashi K.; Serruys P.W.; Fuster V.; Farkouh M.E.; Spertus J.A.; Cohen
D.J.; Park S.-J.; Park D.-W.; Ahn J.-M.; Kappetein A.P.; Head S.J.; Thuijs
D.J.; Onuma Y.; Kent D.M.; Steyerberg E.W.; van Klaveren D.
Institution
(Takahashi) Department of Cardiology, Amsterdam Universities Medical
Centers, Academic Medical Center, University of Amsterdam, Amsterdam,
Netherlands
(Serruys, Onuma) Department of Cardiology, National University of Ireland,
Galway, Ireland
(Fuster) Zena and Michael Wiener Cardiovascular Institute, Icahn School of
Medicine at Mount Sinai, New York, NY, United States
(Fuster) Centro Nacional De Investigaciones Cardiovasculares Carlos III,
Madrid, Spain
(Farkouh) Peter Munk Cardiac Centre and The Heart and Stroke Richard Lewar
Centre, University of Toronto, Toronto, ON, Canada
(Spertus) Saint Luke's Mid America Heart Institute, Kansas City, MO,
United States
(Spertus, Cohen) University of Missouri-Kansas City, Kansas City, MO,
United States
(Park, Park, Ahn) Department of Cardiology, Asan Medical Center, Seoul,
South Korea
(Kappetein, Head, Thuijs) Department of Cardiothoracic Surgery, Erasmus
University Medical Centre, Rotterdam, Netherlands
(van Klaveren) Department of Public Health, Erasmus University Medical
Centre, Rotterdam, Netherlands
(Kent) Predictive Analytics and Comparative Effectiveness Center,
Institute for Clinical Research and Health Policy Studies, Tufts Medical
Center, Boston, MA, United States
(Steyerberg) Department of Biomedical Data Sciences, Leiden, Netherlands
(Steyerberg) University Medical Centre, Leiden, Netherlands
Publisher
Lancet Publishing Group
Abstract
Background: Randomised controlled trials are considered the gold standard
for testing the efficacy of novel therapeutic interventions, and typically
report the average treatment effect as a summary result. As the result of
treatment can vary between patients, basing treatment decisions for
individual patients on the overall average treatment effect could be
suboptimal. We aimed to develop an individualised decision making tool to
select an optimal revascularisation strategy in patients with complex
coronary artery disease. <br/>Method(s): The SYNTAX Extended Survival
(SYNTAXES) study is an investigator-driven extension follow-up of a
multicentre, randomised controlled trial done in 85 hospitals across 18
North American and European countries between March, 2005, and April,
2007. Patients with de-novo three-vessel and left main coronary artery
disease were randomly assigned (1:1) to either the percutaneous coronary
intervention (PCI) group or coronary artery bypass grafting (CABG) group.
The SYNTAXES study ascertained 10-year all-cause deaths. We used Cox
regression to develop a clinical prognostic index for predicting death
over a 10-year period, which was combined, in a second stage, with
assigned treatment (PCI or CABG) and two prespecified effect-modifiers,
which were selected on the basis of previous evidence: disease type
(three-vessel disease or left main coronary artery disease) and anatomical
SYNTAX score. We used similar techniques to develop a model to predict the
5-year risk of major adverse cardiovascular events (defined as a composite
of all-cause death, non-fatal stroke, or non-fatal myocardial infarction)
in patients receiving PCI or CABG. We then assessed the ability of these
models to predict the risk of death or a major adverse cardiovascular
event, and their differences (ie, the estimated benefit of CABG versus PCI
by calculating the absolute risk difference between the two strategies) by
cross-validation with the SYNTAX trial (n=1800 participants) and external
validation in the pooled population (n=3380 participants) of the FREEDOM,
BEST, and PRECOMBAT trials. The concordance (C)-index was used to measure
discriminative ability, and calibration plots were used to assess the
degree of agreement between predictions and observations. <br/>Finding(s):
At cross-validation, the newly developed SYNTAX score II, termed SYNTAX
score II 2020, showed a helpful discriminative ability in both treatment
groups for predicting 10-year all-cause deaths (C-index=0.73 [95% CI
0.69-0.76] for PCI and 0.73 [0.69-0.76] for CABG) and 5-year major adverse
cardiovascular events (C-index=0.65 [0.61-0.69] for PCI and C-index=0.71
[0.67-0.75] for CABG). At external validation, the SYNTAX score II 2020
showed helpful discrimination (C-index=0.67 [0.63-0.70] for PCI and
C-index=0.62 [0.58-0.66] for CABG) and good calibration for predicting
5-year major adverse cardiovascular events. The estimated treatment
benefit of CABG over PCI varied substantially among patients in the trial
population, and the benefit predictions were well calibrated.
<br/>Interpretation(s): The SYNTAX score II 2020 for predicting 10-year
deaths and 5-year major adverse cardiovascular events can help to identify
individuals who will benefit from either CABG or PCI, thereby supporting
heart teams, patients, and their families to select optimal
revascularisation strategies. <br/>Funding(s): The German Heart Research
Foundation and the Patient-Centered Outcomes Research
Institute.<br/>Copyright &#xa9; 2020 Elsevier Ltd

<65>
Accession Number
2007852635
Title
Efficacy and safety of trimetazidine after percutaneous coronary
intervention (ATPCI): a randomised, double-blind, placebo-controlled
trial.
Source
The Lancet. 396 (10254) (pp 830-838), 2020. Date of Publication: 19 - 25
September 2020.
Author
Ferrari R.; Ford I.; Fox K.; Challeton J.P.; Correges A.; Tendera M.;
Widimsky P.; Danchin N.
Institution
(Ferrari) Cardiovascular Centre, University of Ferrara, Ospedale di Cona,
Ferrara, Italy
(Ferrari) Maria Cecilia Hospital, Cotignola, Ravenna, Italy
(Ford) Robertson Centre for Biostatistics, University of Glasgow, Glasgow,
United Kingdom
(Fox) National Heart and Lung Institute, Imperial College London, London,
United Kingdom
(Fox) Royal Brompton Hospital, London, United Kingdom
(Challeton, Correges) Institut de Recherches Internationales Servier,
Suresnes, France
(Tendera) Department of Cardiology and Structural Heart Disease, Medical
University of Silesia, Katowice, Poland
(Widimsky) Cardiocenter, Third Faculty of Medicine, Charles University,
Prague, Czechia
(Danchin) Department of Cardiology, Hopital Europeen Georges Pompidou,
Assistance Publique-Hopitaux de Paris, Paris, France
(Danchin) Universite Paris-Descartes, Paris, France
Publisher
Lancet Publishing Group
Abstract
Background: Angina might persist or reoccur despite successful
revascularisation with percutaneous coronary intervention (PCI) and
antianginal therapy. Additionally, PCI in stable patients has not been
shown to improve survival compared with optimal medical therapy.
Trimetazidine is an antianginal agent that improves energy metabolism of
the ischaemic myocardium and might improve outcomes and symptoms of
patients who recently had a PCI. In this study, we aimed to assess the
long-term potential benefits and safety of trimetazidine added to standard
evidence-based medical treatment in patients who had a recent successful
PCI. <br/>Method(s): We did a randomised, double-blind,
placebo-controlled, event-driven trial of trimetazidine added to standard
background therapy in patients who had undergone successful PCI at 365
centres in 27 countries across Europe, South America, Asia, and north
Africa. Eligible patients were aged 21-85 years and had had either
elective PCI for stable angina or urgent PCI for unstable angina or non-ST
segment elevation myocardial infarction less than 30 days before
randomisation. Patients were randomly assigned by an interactive web
response system to oral trimetazidine 35 mg modified-release twice daily
or matching placebo. Participants, study investigators, and all study
staff were masked to treatment allocation. The primary efficacy endpoint
was a composite of cardiac death; hospital admission for a cardiac event;
recurrence or persistence of angina requiring an addition, switch, or
increase of the dose of at least one antianginal drug; or recurrence or
persistence of angina requiring a coronary angiography. Efficacy analyses
were done according to the intention-to-treat principle. Safety was
assessed in all patients who had at least one dose of study drug. This
study is registered with the EU Clinical Trials Register (EudraCT
2010-022134-89). <br/>Finding(s): From Sept 17, 2014, to June 15, 2016,
6007 patients were enrolled and randomly assigned to receive either
trimetazidine (n=2998) or placebo (n=3009). After a median follow-up of
47.5 months (IQR 42.3-53.3), incidence of primary endpoint events was not
significantly different between the trimetazidine group (700 [23.3%]
patients) and the placebo group (714 [23.7%]; hazard ratio 0.98 [95% CI
0.88-1.09], p=0.73). When analysed individually, there were no significant
differences in the incidence of the components of the primary endpoint
between the treatment groups. Similar results were obtained when patients
were categorised according to whether they had an elective or urgent PCI.
1219 (40.9%) of 2983 patients in the trimetazidine group and 1230 (41.1%)
of 2990 patients in the placebo group had serious treatment-emergent
adverse events. Frequencies of adverse events of interest were similar
between the groups. <br/>Interpretation(s): Our results show that the
routine use of oral trimetazidine 35 mg twice daily over several years in
patients receiving optimal medical therapy, after successful PCI, does not
influence the recurrence of angina or the outcome; these findings should
be taken into account when considering the place of trimetazidine in
clinical practice. However, the long-term prescription of this treatment
does not appear to be associated with any statistically significant safety
concerns in the population studied. <br/>Funding(s):
Servier.<br/>Copyright &#xa9; 2020 Elsevier Ltd

<66>
Accession Number
2007060841
Title
Dexmedetomidine for reduction of atrial fibrillation and delirium after
cardiac surgery (DECADE): a randomised placebo-controlled trial.
Source
The Lancet. 396 (10245) (pp 177-185), 2020. Date of Publication: 18 - 24
July 2020.
Author
Turan A.; Duncan A.; Leung S.; Karimi N.; Fang J.; Mao G.; Hargrave J.;
Gillinov M.; Trombetta C.; Ayad S.; Hassan M.; Feider A.; Howard-Quijano
K.; Ruetzler K.; Sessler D.I.; Bergese S.; De Oliveira G.; Honar H.; Niazi
A.; Elliott K.; Hamadnalla H.; Chodavarapu P.; Bajracharya G.; Fitzgerald
P.; Cuko E.; Akhtar Z.; Lokhande C.; Khan M.Z.; Khoshknabi D.; Riter Q.;
Hutcherson M.; Yagar S.; Glosse L.; Saha P.; Raza S.
Institution
(Turan, Fang, Mao, Ruetzler, Sessler) Department of Outcomes Research,
Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States
(Ayad, Hassan) Department of Regional Practice, Cleveland Clinic,
Cleveland, OH, United States
(Turan, Ayad, Ruetzler) Department of General Anesthesiology, Cleveland
Clinic, Cleveland, OH, United States
(Duncan, Hargrave, Trombetta) Department of Cardiovascular Anesthesiology,
Cleveland Clinic, Cleveland, OH, United States
(Mao) Department of Quantitative Health Sciences, Cleveland Clinic,
Cleveland, OH, United States
(Gillinov) Department of Thoracic and Cardiovascular Surgery, Cleveland
Clinic, Cleveland, OH, United States
(Leung) Department of Radiology, Metrohealth Hospital, Cleveland, OH,
United States
(Karimi) Department of Anesthesiology, University of Rochester, Rochester,
NY, United States
(Feider) Department of Anesthesia, University of Iowa Hospitals and
Clinics, Iowa City, IA, United States
(Howard-Quijano) Department of Anesthesiology and Perioperative Medicine,
University of Pittsburgh School of Medicine and University of Pittsburgh
Medical Center, Pittsburgh, PA, United States
Publisher
Lancet Publishing Group
Abstract
Background: Atrial fibrillation and delirium are common consequences of
cardiac surgery. Dexmedetomidine has unique properties as sedative agent
and might reduce the risk of each complication. This study coprimarily
aimed to establish whether dexmedetomidine reduces the incidence of
new-onset atrial fibrillation and the incidence of delirium.
<br/>Method(s): A randomised, placebo-controlled trial was done at six
academic hospitals in the USA. Patients who had had cardiac surgery with
cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1,
stratified by site, to dexmedetomidine or normal saline placebo.
Randomisation was computer generated with random permuted block size 2 and
4, and allocation was concealed by a web-based system. Patients,
caregivers, and evaluators were all masked to treatment. The study drug
was prepared by the pharmacy or an otherwise uninvolved research associate
so that investigators and clinicians were fully masked to allocation.
Participants were given either dexmedetomidine infusion or saline placebo
started before the surgical incision at a rate of 0.1 mug/kg per h then
increased to 0.2 mug/kg per h at the end of bypass, and postoperatively
increased to 0.4 mug/kg per h, which was maintained until 24 h. The
coprimary outcomes were atrial fibrillation and delirium occurring between
intensive care unit admission and the earlier of postoperative day 5 or
hospital discharge. All analyses were intention-to-treat. The trial is
registered with ClinicalTrials.gov, NCT02004613 and is closed.
<br/>Finding(s): 798 patients of 3357 screened were enrolled from April
17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the
last designated interim analysis. Among 798 patients randomly assigned,
794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned
to placebo. The incidence of atrial fibrillation was 121 (30%) in 397
patients given dexmedetomidine and 134 (34%) in 395 patients given
placebo, a difference that was not significant: relative risk 0.90 (97.8%
CI 0.72, 1.15; p=0.34). The incidence of delirium was non-significantly
increased from 12% in patients given placebo to 17% in those given
dexmedetomidine: 1.48 (97.8% CI 0.99-2.23). Safety outcomes were
clinically important bradycardia (requiring treatment) and hypotension,
myocardial infarction, stroke, surgical site infection, pulmonary
embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given
dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious
adverse event as determined by clinicians. 1 (<1%) of 391 patients given
dexmedetomidine and 1 (<1%) of 387 patients given placebo died.
<br/>Interpretation(s): Dexmedetomidine infusion, initiated at anaesthetic
induction and continued for 24 h, did not decrease postoperative atrial
arrhythmias or delirium in patients recovering from cardiac surgery.
Dexmedetomidine should not be infused to reduce atrial fibrillation or
delirium in patients having cardiac surgery. <br/>Funding(s): Hospira
Pharmaceuticals.<br/>Copyright &#xa9; 2020 Elsevier Ltd

<67>
Accession Number
2004621435
Title
Percutaneous coronary angioplasty versus coronary artery bypass grafting
in the treatment of unprotected left main stenosis: updated 5-year
outcomes from the randomised, non-inferiority NOBLE trial.
Source
The Lancet. 395 (10219) (pp 191-199), 2020. Date of Publication: 18 - 24
January 2020.
Author
Holm N.R.; Makikallio T.; Lindsay M.M.; Spence M.S.; Erglis A.; Menown
I.B.A.; Trovik T.; Kalinauskas G.; Nielsen P.H.; Niemela M.; Lassen J.F.;
Oldroyd K.; Stradins P.; Walsh S.J.; Graham A.N.J.; Endresen P.C.; Frobert
O.; Trivedi U.; Hildick-Smith D.; Thuesen L.; Christiansen E.H.; Lindsay
M.; Eskola M.; Romppanen H.; Kellerth T.; Jensen L.O.; Linder R.B.A.;
Pentikainen M.; Hervold A.; Banning A.; Zaman A.; Cotton J.; Eriksen E.;
Margus S.; Mogensen L.J.H.; Kervinen K.; Berg G.; Hanratty C.G.; Kumsars
I.; Steigen T.K.; Graham A.N.; Corbascio M.; Kajander O.; Hartikainen J.;
Anttila V.
Institution
(Holm, Mogensen, Christiansen) Department of Cardiology, Aarhus University
Hospital, Aarhus, Denmark
(Nielsen) Department of Cardiac Surgery, Aarhus University Hospital,
Aarhus, Denmark
(Makikallio, Niemela) Department of Cardiology, Oulu University Hospital,
Oulu, Finland
(Anttila) Department of Cardiac Surgery, Oulu University Hospital, Oulu,
Finland
(Lindsay, Oldroyd) Department of Cardiology, Golden Jubilee National
Hospital, Clydebank, United Kingdom
(Berg) Department of Cardiac Surgery, Golden Jubilee National Hospital,
Clydebank, United Kingdom
(Spence, Walsh, Graham) Belfast Heart Centre, Belfast Trust, Belfast,
United Kingdom
(Erglis, Stradins) Latvia Centre of Cardiology, Paul Stradins Clinical
Hospital, Riga, Latvia
(Menown) Craigavon Cardiac Centre, Craigavon, United Kingdom
(Trovik) Department of Cardiology, University Hospital of North Norway,
Tromso, Norway
(Endresen) Department of Cardiovascular Surgery, University Hospital of
North Norway, Tromso, Norway
(Kellerth, Frobert) Department of Cardiology, Faculty of Health, Orebro
University, Orebro, Sweden
(Kalinauskas) Vilnius University, Clinic of Cardiac and Vascular Diseases,
Vilnius, Lithuania
(Lassen) Department of Cardiology, Odense University Hospital, Odense,
Denmark
(Trivedi, Hildick-Smith) Sussex Cardiac Centre, Brighton and Sussex
University Hospital, Brighton, United Kingdom
(Thuesen) Department of Cardiology, Aalborg University Hospital, Aalborg,
Denmark
Publisher
Lancet Publishing Group
Abstract
Background: Percutaneous coronary intervention (PCI) is increasingly used
in revascularisation of patients with left main coronary artery disease in
place of the standard treatment, coronary artery bypass grafting (CABG).
The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in
the treatment of left main coronary artery disease and reported outcomes
after a median follow-up of 3.1 years. We now report updated 5-year
outcomes of the trial. <br/>Method(s): The prospective, randomised,
open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine
northern European countries. Patients with left main coronary artery
disease requiring revascularisation were enrolled and randomly assigned
(1:1) to receive PCI or CABG. The primary endpoint was major adverse
cardiac or cerebrovascular events (MACCE), a composite of all-cause
mortality, non-procedural myocardial infarction, repeat revascularisation,
and stroke. Non-inferiority of PCI to CABG was defined as the upper limit
of the 95% CI of the hazard ratio (HR) not exceeding 1.35 after 275 MACCE
had occurred. Secondary endpoints included all-cause mortality,
non-procedural myocardial infarction, and repeat revascularisation.
Outcomes were analysed in the intention-to-treat population. This trial is
registered with ClinicalTrials.gov, NCT01496651. <br/>Finding(s): Between
Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated
to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early
follow-up. 592 patients in each group were included in this analysis. At a
median of 4.9 years of follow-up, the predefined number of events was
reached for adequate power to assess the primary endpoint. Kaplan-Meier
5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110
events) for CABG (HR 1.58 [95% CI 1.24-2.01]); the HR exceeded the limit
for non-inferiority of PCI compared to CABG. CABG was found to be superior
to PCI for the primary composite endpoint (p=0.0002). All-cause mortality
was estimated in 9% after PCI versus 9% after CABG (HR 1.08 [95% CI
0.74-1.59]; p=0.68); non-procedural myocardial infarction was estimated in
8% after PCI versus 3% after CABG (HR 2.99 [95% CI 1.66-5.39]; p=0.0002);
and repeat revascularisation was estimated in 17% after PCI versus 10%
after CABG (HR 1.73 [95% CI 1.25-2.40]; p=0.0009). <br/>Interpretation(s):
In revascularisation of left main coronary artery disease, PCI was
associated with an inferior clinical outcome at 5 years compared with
CABG. Mortality was similar after the two procedures but patients treated
with PCI had higher rates of non-procedural myocardial infarction and
repeat revascularisation. <br/>Funding(s): Biosensors.<br/>Copyright
&#xa9; 2020 Elsevier Ltd

<68>
Accession Number
2003583472
Title
Safety and efficacy of a self-expanding versus a balloon-expandable
bioprosthesis for transcatheter aortic valve replacement in patients with
symptomatic severe aortic stenosis: a randomised non-inferiority trial.
Source
The Lancet. 394 (10209) (pp 1619-1628), 2019. Date of Publication: 2 - 8
November 2019.
Author
Lanz J.; Kim W.-K.; Walther T.; Burgdorf C.; Mollmann H.; Linke A.;
Redwood S.; Thilo C.; Hilker M.; Joner M.; Thiele H.; Conzelmann L.;
Conradi L.; Kerber S.; Schymik G.; Prendergast B.; Husser O.; Stortecky
S.; Heg D.; Juni P.; Windecker S.; Pilgrim T.
Institution
(Lanz, Stortecky, Windecker, Pilgrim) Department of Cardiology,
Inselspital, Bern University Hospital, Bern, Switzerland
(Kim) Department of Cardiology, Kerckhoff Heart and Thorax Centre, Bad
Nauheim, Germany
(Walther) Department of Cardiac, Thoracic and Thoracic Vascular Surgery,
University Hospital Frankfurt, Frankfurt, Germany
(Burgdorf) Heart and Vascular Centre, Bad Bevensen, Germany
(Mollmann, Husser) Department of Internal Medicine I,
St-Johannes-Hospital, Dortmund, Germany
(Linke) Department of Internal Medicine and Cardiology, Heart Centre
Dresden, Technische Universitat Dresden, Dresden, Germany
(Redwood, Prendergast) Department of Cardiology, St Thomas' Hospital,
London, United Kingdom
(Thilo) Department of Cardiology, Klinikum Augsburg, Augsburg, Germany
(Hilker) Department of Cardiothoracic Surgery, University Medical Centre,
Regensburg, Germany
(Joner) German Heart Centre, Technical University of Munich, Munich,
Germany
(Thiele) Heart Centre Leipzig, Leipzig, Germany
(Conzelmann) Department of Cardiac Surgery, Helios Klinik, Karlsruhe,
Germany
(Conradi) Department of Cardiovascular Surgery, University Heart Centre
Hamburg, Hamburg, Germany
(Kerber) Department of Cardiology, Cardiovascular Centre Bad Neustadt, Bad
Neustadt, Germany
(Schymik) Department of Cardiology, Stadtisches Klinikum Karlsruhe,
Karslruhe, Germany
(Heg) Clinical Trials Unit, University of Bern, Bern, Switzerland
(Juni) Applied Health Research Centre, Li Ka Shing Knowledge Institute of
St Michael's Hospital, Department of Medicine and Institute of Health
Policy, Management, and Evaluation, University of Toronto, Toronto, ON,
Canada
Publisher
Lancet Publishing Group
Abstract
Background: Transcatheter aortic valve replacement (TAVR) is the preferred
treatment option for older patients with symptomatic severe aortic
stenosis. Differences in the properties of available TAVR systems can
affect clinical outcomes. Among patients undergoing TAVR, we compared the
self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN
3 TAVR system with regard to early safety and efficacy. <br/>Method(s): In
this randomised non-inferiority trial, patients (aged >=75 years)
undergoing transfemoral TAVR for treatment of symptomatic severe aortic
stenosis, and who were deemed to be at increased surgical risk, were
recruited at 20 tertiary heart valve centres in Germany, the Netherlands,
Switzerland, and the UK. Participants were randomly assigned (1:1) to
receive treatment with the ACURATE neo or the SAPIEN 3 with a
computer-based randomly permuted block scheme, stratified by study centre
and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM)
category. The primary composite safety and efficacy endpoint comprised
all-cause death, any stroke, life-threatening or disabling bleeding, major
vascular complications, coronary artery obstruction requiring
intervention, acute kidney injury (stage 2 or 3), rehospitalisation for
valve-related symptoms or congestive heart failure, valve-related
dysfunction requiring repeat procedure, moderate or severe prosthetic
valve regurgitation, or prosthetic valve stenosis within 30 days of the
procedure. Endpoint assessors were masked to treatment allocation.
Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the
intention-to-treat population on the basis of a risk-difference margin of
7.7% for the primary composite endpoint, with a one-sided alpha of 0.05.
This trial is registered with ClinicalTrials.gov (number NCT03011346) and
is ongoing but not recruiting. <br/>Finding(s): Between Feb 8, 2017, and
Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82.8
years [SD 4.1]; median STS-PROM score 3.5% [IQR 2.6-5.0]) were enrolled.
30-day follow-up was available for 367 (99%) of 372 patients allocated to
the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3
group. Within 30 days, the primary endpoint occurred in 87 (24%) patients
in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus,
non-inferiority of the ACURATE neo was not met (absolute risk difference
7.1% [upper 95% confidence limit 12.0%], p=0.42). Secondary analysis of
the primary endpoint suggested superiority of the SAPIEN 3 device over the
ACURATE neo device (95% CI for risk difference -1.3 to -12.9, p=0.0156).
The ACURATE neo and SAPIEN 3 groups did not differ in incidence of
all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%]
vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and
moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%])
were more common in the ACURATE neo group. <br/>Interpretation(s): TAVR
with the self-expanding ACURATE neo did not meet non-inferiority compared
to the balloon-expandable SAPIEN 3 device in terms of early safety and
clinical efficacy outcomes. An early composite safety and efficacy
endpoint was useful in discriminating the performance of different TAVR
systems. <br/>Funding(s): Boston Scientific (USA).<br/>Copyright &#xa9;
2019 Elsevier Ltd

<69>
Accession Number
2003305329
Title
Percutaneous coronary intervention versus coronary artery bypass grafting
in patients with three-vessel or left main coronary artery disease:
10-year follow-up of the multicentre randomised controlled SYNTAX trial.
Source
The Lancet. 394 (10206) (pp 1325-1334), 2019. Date of Publication: 12 Oct
2019.
Author
Thuijs D.J.F.M.; Kappetein A.P.; Serruys P.W.; Mohr F.-W.; Morice M.-C.;
Mack M.J.; Holmes D.R.; Curzen N.; Davierwala P.; Noack T.; Milojevic M.;
Dawkins K.D.; da Costa B.R.; Juni P.; Head S.J.; Casselman F.; de Bruyne
B.; Hoj Christiansen E.; Ruiz-Nodar J.M.; Vermeersch P.; Schultz W.;
Sabate M.; Guagliumi G.; Grubitzsch H.; Stangl K.; Darremont O.; Bentala
M.; den Heijer P.; Preda I.; Stoler R.; Szerafin T.; Buckner J.K.; Guber
M.S.; Verberkmoes N.; Akca F.; Feldman T.; Beyersdorf F.; Drieghe B.;
Oldroyd K.; Berg G.; Jeppsson A.; Barber K.; Wolschleger K.; Heiser J.;
van der Harst P.; Mariani M.A.; Reichenspurner H.; Stark C.; Laine M.; Ho
P.C.; Chen J.C.; Zelman R.; Horwitz P.A.; Bochenek A.; Krauze A.;
Grothusen C.; Dudek D.; Heyrich G.; Kolh P.; LeGrand V.; Coelho P.;
Ensminger S.; Nasseri B.; Ingemansson R.; Olivecrona G.; Escaned J.; Guera
R.; Berti S.; Chieffo A.; Burke N.; Mooney M.; Spolaor A.; Hagl C.;
Nabauer M.; Suttorp M.J.; Stine R.A.; McGarry T.; Lucas S.; Endresen K.;
Taussig A.; Accola K.; Canosi U.; Horvath I.; Cannon L.; Talbott J.D.;
Akins C.W.; Kramer R.; Aschermann M.; Killinger W.; Narbute I.; Burzotta
F.; Bogers A.; Zijlstra F.; Eltchaninoff H.; Berland J.; Stefanini G.;
Cruz Gonzalez I.; Hoppe U.; Kiesz S.; Gora B.; Ahlsson A.; Corbascio M.;
Bilfinger T.; Carrie D.; Tchetche D.; Hauptman K.-E.; Stahle E.; James S.;
Sandner S.; Laufer G.; Lang I.; Witkowski A.; Thourani V.; Suryapranata
H.; Redwood S.; Knight C.; MacCarthy P.; de Belder A.; Banning A.;
Gershlick A.
Institution
(Thuijs, Kappetein, Milojevic, Head) Department of Cardiothoracic Surgery,
Erasmus University Medical Centre, Rotterdam, Netherlands
(Kappetein) Medtronic, Maastricht, Netherlands
(Serruys) Department of Cardiology, Imperial College London, London,
United Kingdom
(Mohr, Davierwala, Noack) University Department of Cardiac Surgery, Heart
Centre Leipzig, Leipzig, Germany
(Morice) Department of Cardiology, Cardiovascular Institute Paris-Sud,
Hopital Prive Jacques Cartier, Ramsay Generale de Sante, Massy, France
(Mack) Department of Cardiothoracic Surgery, Baylor University Medical
Centre, Dallas, TX, United States
(Holmes) Department of Cardiovascular Diseases and Internal Medicine, Mayo
Clinic, Rochester, MN, United States
(Curzen) University Hospital Southampton NHS Foundation Trust and School
of Medicine, University of Southampton, Southampton, United Kingdom
(Dawkins) Shockwave Medical Inc., Santa Clara, CA, United States
(da Costa, Juni) Applied Health Research Centre, Li Ka Shing Knowledge
Institute of St Michael's Hospital, University of Toronto, Toronto, ON,
Canada
(Juni) Department of Medicine, Institute of Health Policy, Management and
Evaluation, University of Toronto, Toronto, ON, Canada
(da Costa) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Head) Medtronic, Minneapolis, MN, United States
Publisher
Lancet Publishing Group
Abstract
Background: The Synergy between PCI with Taxus and Cardiac Surgery
(SYNTAX) trial was a non-inferiority trial that compared percutaneous
coronary intervention (PCI) using first-generation paclitaxel-eluting
stents with coronary artery bypass grafting (CABG) in patients with
de-novo three-vessel and left main coronary artery disease, and reported
results up to 5 years. We now report 10-year all-cause death results.
<br/>Method(s): The SYNTAX Extended Survival (SYNTAXES) study is an
investigator-driven extension of follow-up of a multicentre, randomised
controlled trial done in 85 hospitals across 18 North American and
European countries. Patients with de-novo three-vessel and left main
coronary artery disease were randomly assigned (1:1) to the PCI group or
CABG group. Patients with a history of PCI or CABG, acute myocardial
infarction, or an indication for concomitant cardiac surgery were
excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause
death, which was assessed according to the intention-to-treat principle.
Prespecified subgroup analyses were performed according to the presence or
absence of left main coronary artery disease and diabetes, and according
to coronary complexity defined by core laboratory SYNTAX score tertiles.
This study is registered with ClinicalTrials.gov, NCT03417050.
<br/>Finding(s): From March, 2005, to April, 2007, 1800 patients were
randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status
information at 10 years was complete for 841 (93%) patients in the PCI
group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%)
patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17
[95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease,
151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG
(hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main
coronary artery disease, 93 (26%) of 357 had died after PCI versus 98
(28%) of 348 after CABG (0.90 [0.68-1.20], p<inf>interaction</inf>=0.019).
There was no treatment-by-subgroup interaction with diabetes
(p<inf>interaction</inf>=0.66) and no linear trend across SYNTAX score
tertiles (p<inf>trend</inf>=0.30). <br/>Interpretation(s): At 10 years, no
significant difference existed in all-cause death between PCI using
first-generation paclitaxel-eluting stents and CABG. However, CABG
provided a significant survival benefit in patients with three-vessel
disease, but not in patients with left main coronary artery disease.
<br/>Funding(s): German Foundation of Heart Research (SYNTAXES study,
5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study,
0-5-year follow-up).<br/>Copyright &#xa9; 2019 Elsevier Ltd

<70>
Accession Number
2003305307
Title
Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen
after successful coronary stenting in patients with atrial fibrillation
(ENTRUST-AF PCI): a randomised, open-label, phase 3b trial.
Source
The Lancet. 394 (10206) (pp 1335-1343), 2019. Date of Publication: 12 - 18
October 2019.
Author
Vranckx P.; Valgimigli M.; Eckardt L.; Tijssen J.; Lewalter T.; Gargiulo
G.; Batushkin V.; Campo G.; Lysak Z.; Vakaliuk I.; Milewski K.; Laeis P.;
Reimitz P.-E.; Smolnik R.; Zierhut W.; Goette A.
Institution
(Vranckx) Department of Cardiology and Intensive Care, Jessa Ziekenhuis,
Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt,
Belgium
(Valgimigli, Gargiulo) Department of Cardiology, Inselspital, Bern
University Hospital, University of Bern, Bern, Switzerland
(Eckardt, Lewalter, Goette) Atrial Fibrillation Network, Munster, Germany
(Eckardt) Department of Cardiology and Angiology, Division of
Electrophysiology, University of Munster, Munster, Germany
(Tijssen) Department of Cardiology, Amsterdam University Medical Centers,
University of Amsterdam, Amsterdam, Netherlands
(Tijssen) Cardialysis, Rotterdam, Netherlands
(Lewalter) Department of Cardiology, Hospital Munich South, Munich,
Germany
(Lewalter) University of Bonn, Bonn, Germany
(Gargiulo) Department of Advanced Biomedical Sciences, Federico II
University of Naples, Naples, Italy
(Batushkin) Department of Cardiology, Kyiv City Clinical Hospital #5,
Kiev, Ukraine
(Campo) Cardiovascular Institute, Azienda Ospedaliero-Universitaria di
Ferrara, Cona, Venice, Italy
(Campo) Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy
(Lysak) Department of Cardiac Rehabilitation, Oleksandrivska Kyiv City
Clinical Hospital, Kiev, Ukraine
(Milewski) Center for Cardiovascular Research and Development, American
Heart of Poland Katowice, Poland
(Milewski) The Jerzy Kukuczka Academy of Physical Education, Faculty of
Physiotherapy, Katowice, Katowice, Poland
(Vakaliuk) Department Internal Medicine No2 and Nursing, Ivano-Frankivsk
National Medical University, Ivano-Frankivsk, Ukraine
(Vakaliuk) Department of Anesthesiology with Wards of Intensive Care,
Ivano-Frankivsk Regional Clinical Cardiological Clinic, Ivano-Frankivsk,
Ukraine
(Laeis, Reimitz, Smolnik, Zierhut) Daiichi Sankyo Europe, Munich, Germany
(Goette) Cardiology and Intensive Care Medicine, St Vincenz-Hospital,
Paderborn, Germany
(Goette) Working Group of Molecular Electrophysiology, University Hospital
Magdeburg, Magdeburg, Germany
Publisher
Lancet Publishing Group
Abstract
Background: We aimed to assess the safety of edoxaban in combination with
P2Y12 inhibition in patients with atrial fibrillation who had percutaneous
coronary intervention (PCI). <br/>Method(s): ENTRUST-AF PCI was a
randomised, multicentre, open-label, non-inferiority phase 3b trial with
masked outcome evaluation, done at 186 sites in 18 countries. Patients had
atrial fibrillation requiring oral anticoagulation, were aged at least 18
years, and had a successful PCI for stable coronary artery disease or
acute coronary syndrome. Participants were randomly assigned (1:1) from 4
h to 5 days after PCI using concealed, stratified, and blocked web-based
central randomisation to either edoxaban (60 mg once daily) plus a P2Y12
inhibitor for 12 months or a vitamin K antagonist (VKA) in combination
with a P2Y12 inhibitor and aspirin (100 mg once daily, for 1-12 months).
The edoxaban dose was reduced to 30 mg per day if one or more factors
(creatinine clearance 15-50 mL/min, bodyweight <=60 kg, or concomitant use
of specified potent P-glycoprotein inhibitors) were present. The primary
endpoint was a composite of major or clinically relevant non-major (CRNM)
bleeding within 12 months. The primary analysis was done in the
intention-to-treat population and safety was assessed in all patients who
received at least one dose of their assigned study drug. This trial is
registered with ClinicalTrials.gov, NCT02866175, is closed to new
participants, and follow-up is completed. <br/>Finding(s): From Feb 24,
2017, through May 7, 2018, 1506 patients were enrolled and randomly
assigned to the edoxaban regimen (n=751) or VKA regimen (n=755). Median
time from PCI to randomisation was 45.1 h (IQR 22.2-76.2). Major or CRNM
bleeding events occurred in 128 (17%) of 751 patients (annualised event
rate 20.7%) with the edoxaban regimen and 152 (20%) of 755 patients
(annualised event rate 25.6%) patients with the VKA regimen; hazard ratio
0.83 (95% CI 0.65-1.05; p=0.0010 for non-inferiority, margin hazard ratio
1.20; p=0.1154 for superiority). <br/>Interpretation(s): In patients with
atrial fibrillation who had PCI, the edoxaban-based regimen was
non-inferior for bleeding compared with the VKA-based regimen, without
significant differences in ischaemic events. <br/>Funding(s): Daiichi
Sankyo.<br/>Copyright &#xa9; 2019 Elsevier Ltd

<71>
Accession Number
2002660818
Title
Effectiveness of polypill for primary and secondary prevention of
cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial.
Source
The Lancet. 394 (10199) (pp 672-683), 2019. Date of Publication: 24 - 30
August 2019.
Author
Roshandel G.; Khoshnia M.; Poustchi H.; Hemming K.; Kamangar F.; Gharavi
A.; Ostovaneh M.R.; Nateghi A.; Majed M.; Navabakhsh B.; Merat S.;
Pourshams A.; Nalini M.; Malekzadeh F.; Sadeghi M.; Mohammadifard N.;
Sarrafzadegan N.; Naemi-Tabiei M.; Fazel A.; Brennan P.; Etemadi A.;
Boffetta P.; Thomas N.; Marshall T.; Cheng K.K.; Malekzadeh R.
Institution
(Roshandel, Khoshnia, Poustchi, Gharavi, Ostovaneh, Nateghi, Majed,
Navabakhsh, Pourshams, Nalini, Malekzadeh, Malekzadeh) Digestive Disease
Research Center, Digestive Disease Research Institute, Shariati Hospital,
Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of
(Poustchi, Pourshams, Malekzadeh) Digestive Oncology Research Center,
Digestive Disease Research Institute, Shariati Hospital, Tehran University
of Medical Sciences, Tehran, Iran, Islamic Republic of
(Merat, Malekzadeh) Liver and Pancreaticobiliary Disease Research Center,
Digestive Disease Research Institute, Shariati Hospital, Tehran University
of Medical Sciences, Tehran, Iran, Islamic Republic of
(Roshandel, Khoshnia, Naemi-Tabiei, Fazel) Golestan Research Center of
Gastroenterology and Hepatology, Golestan University of Medical Sciences,
Gorgan, Iran, Islamic Republic of
(Hemming, Thomas, Marshall, Cheng) Institute of Applied Health Research,
University of Birmingham, Birmingham, United Kingdom
(Kamangar) Department of Biology, School of Computer, Mathematical, and
Natural Sciences, Morgan State University, Baltimore, MD, United States
(Sadeghi) Cardiac Rehabilitation Research Center, Cardiovascular Research
Institute, Isfahan University of Medical Sciences, Isfahan, Iran, Islamic
Republic of
(Mohammadifard) Isfahan Cardiovascular Research Center, Cardiovascular
Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran,
Islamic Republic of
(Sarrafzadegan) Heart Failure Research Center, Cardiovascular Research
Institute, Isfahan University of Medical Sciences, Isfahan, Iran, Islamic
Republic of
(Brennan) Section of Genetics, International Agency for Research on
Cancer, WHO, Lyon, France
(Etemadi) Division of Cancer Epidemiology and Genetics, National Cancer
Institute, National Institutes of Health, Bethesda, MD, United States
(Boffetta) Tisch Cancer Institute, Icahn School of Medicine at Mount
Sinai, New York, NY, United States
(Boffetta) Department of Medical and Surgical Sciences, University of
Bologna, Italy
Publisher
Lancet Publishing Group
Abstract
Background: A fixed-dose combination therapy (polypill strategy) has been
proposed as an approach to reduce the burden of cardiovascular disease,
especially in low-income and middle-income countries (LMICs). The PolyIran
study aimed to assess the effectiveness and safety of a four-component
polypill including aspirin, atorvastatin, hydrochlorothiazide, and either
enalapril or valsartan for primary and secondary prevention of
cardiovascular disease. <br/>Method(s): The PolyIran study was a
two-group, pragmatic, cluster-randomised trial nested within the Golestan
Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75
years from the Golestan province in Iran. Clusters (villages) were
randomly allocated (1:1) to either a package of non-pharmacological
preventive interventions alone (minimal care group) or together with a
once-daily polypill tablet (polypill group). Randomisation was stratified
by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the
unit of randomisation. We used a balanced randomisation algorithm,
considering block sizes of 20 and balancing for cluster size or natural
log of the cluster size (depending on the skewness within strata).
Randomisation was done at a fixed point in time (Jan 18, 2011) by
statisticians at the University of Birmingham (Birmingham, UK),
independent of the local study team. The non-pharmacological preventive
interventions (including educational training about healthy lifestyle-eg,
healthy diet with low salt, sugar, and fat content, exercise, weight
control, and abstinence from smoking and opium) were delivered by the
PolyIran field visit team at months 3 and 6, and then every 6 months
thereafter. Two formulations of polypill tablet were used in this study.
Participants were first prescribed polypill one (hydrochlorothiazide 12.5
mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants
who developed cough during follow-up were switched by a trained study
physician to polypill two, which included valsartan 40 mg instead of
enalapril 5 mg. Participants were followed up for 60 months. The primary
outcome-occurrence of major cardiovascular events (including
hospitalisation for acute coronary syndrome, fatal myocardial infarction,
sudden death, heart failure, coronary artery revascularisation procedures,
and non-fatal and fatal stroke)-was centrally assessed by the GCS
follow-up team, who were masked to allocation status. We did
intention-to-treat analyses by including all participants who met
eligibility criteria in the two study groups. The trial was registered
with ClinicalTrials.gov, number NCT01271985. <br/>Finding(s): Between Feb
22, 2011, and April 15, 2013, we enrolled 6838 individuals into the
study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120
clusters) in the polypill group. 1761 (51.5%) of 3421 participants in the
polypill group were women, as were 1679 (49.1%) of 3417 participants in
the minimal care group. Median adherence to polypill tablets was 80.5%
(IQR 48.5-92.2). During follow-up, 301 (8.8%) of 3417 participants in the
minimal care group had major cardiovascular events compared with 202
(5.9%) of 3421 participants in the polypill group (adjusted hazard ratio
[HR] 0.66, 95% CI 0.55-0.80). We found no statistically significant
interaction with the presence (HR 0.61, 95% CI 0.49-0.75) or absence of
pre-existing cardiovascular disease (0.80; 0.51-1.12;
p<inf>interaction</inf>=0.19). When restricted to participants in the
polypill group with high adherence, the reduction in the risk of major
cardiovascular events was even greater compared with the minimal care
group (adjusted HR 0.43, 95% CI 0.33-0.55). The frequency of adverse
events was similar between the two study groups. 21 intracranial
haemorrhages were reported during the 5 years of follow-up-ten
participants in the polypill group and 11 participants in the minimal care
group. There were 13 physician-confirmed diagnoses of upper
gastrointestinal bleeding in the polypill group and nine in the minimal
care group. <br/>Interpretation(s): Use of polypill was effective in
preventing major cardiovascular events. Medication adherence was high and
adverse event numbers were low. The polypill strategy could be considered
as an additional effective component in controlling cardiovascular
diseases, especially in LMICs. <br/>Funding(s): Tehran University of
Medical Sciences, Barakat Foundation, and Alborz Darou.<br/>Copyright
&#xa9; 2019 World Health Organization. Published by Elsevier Ltd/Inc/BV.
All rights reserved.

<72>
Accession Number
2001871184
Title
Effect of ultra-short-term treatment of patients with iron deficiency or
anaemia undergoing cardiac surgery: a prospective randomised trial.
Source
The Lancet. 393 (10187) (pp 2201-2212), 2019. Date of Publication: 1 - 7
June 2019.
Author
Spahn D.R.; Schoenrath F.; Spahn G.H.; Seifert B.; Stein P.; Theusinger
O.M.; Kaserer A.; Hegemann I.; Hofmann A.; Maisano F.; Falk V.
Institution
(Spahn, Spahn, Stein, Kaserer, Hofmann) Institute of Anaesthesiology,
University of Zurich and University Hospital Zurich, Zurich, Switzerland
(Schoenrath, Falk) Department of Cardiothoracic and Vascular Surgery,
German Heart Centre Berlin, Berlin, Germany
(Schoenrath) German Centre for Cardiovascular Research, partner site
Berlin, Germany
(Seifert) Department of Biostatistics, Epidemiology, Biostatistics and
Prevention Institute, University of Zurich, Switzerland
(Theusinger) Department of Anaesthesiology, University of Zurich and
University Hospital Balgrist, Zurich, Switzerland
(Hegemann) Division of Haematology, University of Zurich and Zurich
University Hospital, Zurich, Switzerland
(Hofmann) School of Surgery, University of Western Australia and School of
Public Health Research, Curtin University, Perth, Western Australia,
Australia
(Maisano) Department of Cardiovascular Surgery, University of Zurich and
University Hospital Zurich, Zurich, Switzerland
(Falk) German Centre for Cardiovascular Research, Berlin, Germany
(Falk) Department of Cardiothoracic Surgery, Charite - Universitatsmedizin
Berlin Universitat Berlin, Humboldt-Universitat zu Berlin, Berlin
Institute of Health, Berlin, Germany
Publisher
Lancet Publishing Group
Abstract
Background: Anaemia and iron deficiency are frequent in patients scheduled
for cardiac surgery. This study assessed whether immediate preoperative
treatment could result in reduced perioperative red blood cell (RBC)
transfusions and improved outcome. <br/>Method(s): In this single-centre,
randomised, double-blind, parallel-group controlled study, patients
undergoing elective cardiac surgery with anaemia (n=253; haemoglobin
concentration (Hb) <120 g/L in women and Hb <130 g/L in men) or isolated
iron deficiency (n=252; ferritin <100 mcg/L, no anaemia) were enrolled.
Participants were randomly assigned (1:1) with the use of a
computer-generated range minimisation (allocation probability 0.8) to
receive either placebo or combination treatment consisting of a slow
infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous
erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic
acid or placebo on the day before surgery. Primary outcome was the number
of RBC transfusions during the first 7 days. This trial is registered with
ClinicalTrials.gov, number NCT02031289. <br/>Finding(s): Between Jan 9,
2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or
isolated iron deficiency and 501 in the registry. The combination
treatment significantly reduced RBC transfusions from a median of one unit
in the placebo group (IQR 0-3) to zero units in the treatment group (0-2,
during the first 7 days (odds ratio 0.70 [95% CI 0.50-0.98] for each
threshold of number of RBC transfusions, p=0.036) and until postoperative
day 90 (p=0.018). Despite fewer RBC units transfused, patients in the
treatment group had a higher haemoglobin concentration, higher
reticulocyte count, and a higher reticulocyte haemoglobin content during
the first 7 days (p<=0.001). Combined allogeneic transfusions were less in
the treatment group (0 [IQR 0-2]) versus the placebo group (1 [0-3])
during the first 7 days (p=0.038) and until postoperative day 90
(p=0.019). 73 (30%) serious adverse events were reported in the treatment
group group versus 79 (33%) in the placebo group. <br/>Interpretation(s):
An ultra-short-term combination treatment with intravenous iron,
subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid
reduced RBC and total allogeneic blood product transfusions in patients
with preoperative anaemia or isolated iron deficiency undergoing elective
cardiac surgery. <br/>Funding(s): Vifor Pharma and Swiss Foundation for
Anaesthesia Research.<br/>Copyright &#xa9; 2019 Elsevier Ltd

<73>
Accession Number
2001516901
Title
Efficacy and safety of statin therapy in older people: a meta-analysis of
individual participant data from 28 randomised controlled trials.
Source
The Lancet. 393 (10170) (pp 407-415), 2019. Date of Publication: 2 - 8
February 2019.
Author
Armitage J.; Baigent C.; Barnes E.; Betteridge D.J.; Blackwell L.; Blazing
M.; Bowman L.; Braunwald E.; Byington R.; Cannon C.; Clearfield M.;
Colhoun H.; Collins R.; Dahlof B.; Davies K.; Davis B.; de Lemos J.; Downs
J.R.; Durrington P.; Emberson J.; Fellstrom B.; Flather M.; Ford I.;
Franzosi M.G.; Fulcher J.; Fuller J.; Furberg C.; Gordon D.; Goto S.;
Gotto A.; Halls H.; Harper C.; Hawkins C.M.; Herrington W.; Hitman G.;
Holdaas H.; Holland L.; Jardine A.; Jukema J.W.; Kastelein J.; Kean S.;
Keech A.; Kirby A.; Kjekshus J.; Knatterud (deceased) G.; Knopp (deceased)
R.; Koenig W.; Koren M.; Krane V.; Landray M.J.; LaRosa J.; Lonn E.;
MacFarlane P.; MacMahon S.; Maggioni A.; Marchioli R.; Marschner I.;
Mihaylova B.; Moye L.; Murphy S.; Nakamura H.; Neil A.; Newman C.;
O'Connell R.; Packard C.; Parish S.; Pedersen T.; Peto R.; Pfeffer M.;
Poulter N.; Preiss D.; Reith C.; Ridker P.; Robertson M.; Sacks F.; Sattar
N.; Schmieder R.; Serruys P.; Sever P.; Shaw J.; Shear C.; Simes J.;
Sleight P.; Spata E.; Tavazzi L.; Tobert J.; Tognoni G.; Tonkin A.;
Trompet S.; Varigos J.; Wanner C.; Wedel H.; White H.; Wikstrand J.;
Wilhelmsen L.; Wilson K.; Young R.; Yusuf S.; Zannad F.
Publisher
Lancet Publishing Group
Abstract
Background: Statin therapy has been shown to reduce major vascular events
and vascular mortality in a wide range of individuals, but there is
uncertainty about its efficacy and safety among older people. We undertook
a meta-analysis of data from all large statin trials to compare the
effects of statin therapy at different ages. <br/>Method(s): In this
meta-analysis, randomised trials of statin therapy were eligible if they
aimed to recruit at least 1000 participants with a scheduled treatment
duration of at least 2 years. We analysed individual participant data from
22 trials (n=134 537) and detailed summary data from one trial (n=12 705)
of statin therapy versus control, plus individual participant data from
five trials of more intensive versus less intensive statin therapy (n=39
612). We subdivided participants into six age groups (55 years or younger,
56-60 years, 61-65 years, 66-70 years, 71-75 years, and older than 75
years). We estimated effects on major vascular events (ie, major coronary
events, strokes, and coronary revascularisations), cause-specific
mortality, and cancer incidence as the rate ratio (RR) per 1.0 mmol/L
reduction in LDL cholesterol. We compared proportional risk reductions in
different age subgroups by use of standard chi² tests for
heterogeneity when there were two groups, or trend when there were more
than two groups. <br/>Finding(s): 14 483 (8%) of 186 854 participants in
the 28 trials were older than 75 years at randomisation, and the median
follow-up duration was 4.9 years. Overall, statin therapy or a more
intensive statin regimen produced a 21% (RR 0.79, 95% CI 0.77-0.81)
proportional reduction in major vascular events per 1.0 mmol/L reduction
in LDL cholesterol. We observed a significant reduction in major vascular
events in all age groups. Although proportional reductions in major
vascular events diminished slightly with age, this trend was not
statistically significant (p<inf>trend</inf>=0.06). Overall, statin or
more intensive therapy yielded a 24% (RR 0.76, 95% CI 0.73-0.79)
proportional reduction in major coronary events per 1.0 mmol/L reduction
in LDL cholesterol, and with increasing age, we observed a trend towards
smaller proportional risk reductions in major coronary events
(p<inf>trend</inf>=0.009). We observed a 25% (RR 0.75, 95% CI 0.73-0.78)
proportional reduction in the risk of coronary revascularisation
procedures with statin therapy or a more intensive statin regimen per 1.0
mmol/L lower LDL cholesterol, which did not differ significantly across
age groups (p<inf>trend</inf>=0.6). Similarly, the proportional reductions
in stroke of any type (RR 0.84, 95% CI 0.80-0.89) did not differ
significantly across age groups (p<inf>trend</inf>=0.7). After exclusion
of four trials which enrolled only patients with heart failure or
undergoing renal dialysis (among whom statin therapy has not been shown to
be effective), the trend to smaller proportional risk reductions with
increasing age persisted for major coronary events
(p<inf>trend</inf>=0.01), and remained non-significant for major vascular
events (p<inf>trend</inf>=0.3). The proportional reduction in major
vascular events was similar, irrespective of age, among patients with
pre-existing vascular disease (p<inf>trend</inf>=0.2), but appeared
smaller among older than among younger individuals not known to have
vascular disease (p<inf>trend</inf>=0.05). We found a 12% (RR 0.88, 95% CI
0.85-0.91) proportional reduction in vascular mortality per 1.0 mmol/L
reduction in LDL cholesterol, with a trend towards smaller proportional
reductions with older age (p<inf>trend</inf>=0.004), but this trend did
not persist after exclusion of the heart failure or dialysis trials
(p<inf>trend</inf>=0.2). Statin therapy had no effect at any age on
non-vascular mortality, cancer death, or cancer incidence.
<br/>Interpretation(s): Statin therapy produces significant reductions in
major vascular events irrespective of age, but there is less direct
evidence of benefit among patients older than 75 years who do not already
have evidence of occlusive vascular disease. This limitation is now being
addressed by further trials. <br/>Funding(s): Australian National Health
and Medical Research Council, National Institute for Health Research
Oxford Biomedical Research Centre, UK Medical Research Council, and
British Heart Foundation.<br/>Copyright &#xa9; 2019 The Author(s).
Published by Elsevier Ltd. This is an Open Access article under the CC
BY-NC-ND 4.0 license

<74>
Accession Number
627140813
Title
Protective ventilation with high versus low positive end-expiratory
pressure during one-lung ventilation for thoracic surgery (PROTHOR): Study
protocol for a randomized controlled trial.
Source
Trials. 20 (1) (no pagination), 2019. Article Number: 213. Date of
Publication: 11 Apr 2019.
Author
Kiss T.; Wittenstein J.; Becker C.; Birr K.; Cinnella G.; Cohen E.; El
Tahan M.R.; Falcao L.F.; Gregoretti C.; Granell M.; Hachenberg T.;
Hollmann M.W.; Jankovic R.; Karzai W.; Krassler J.; Loop T.; Licker M.J.;
Marczin N.; Mills G.H.; Murrell M.T.; Neskovic V.; Nisnevitch-Savarese Z.;
Pelosi P.; Rossaint R.; Schultz M.J.; Serpa Neto A.; Severgnini P.;
Szegedi L.; Vegh T.; Voyagis G.; Zhong J.; Gama De Abreu M.; Senturk M.
Institution
(Kiss, Wittenstein, Becker, Birr, Gama De Abreu) Department of
Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group,
University Hospital Carl Gustav Carus, Technische Universitat Dresden,
Dresden, Germany
(Cinnella) Department of Anesthesia and Intensive Care, OO Riuniti
Hospital, University of Foggia, Foggia, Italy
(Cohen) Department of Anesthesiology, Mount Sinai Hospital, New York,
United States
(El Tahan) Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
(Falcao) Federal University of Sao Paulo, Sao Paulo, Brazil
(Gregoretti) UOC Anestesia e Rianimazione A.O.Universitaria p. Giaccone,
Dipartimento Di.Chir.On.S., Universita Degli Studi di Palermo, Palermo,
Italy
(Granell) Hospital General Universitario de Valencia, Valencia, Spain
(Hachenberg) University Hospital Magdeburg, Magdeburg, Germany
(Hollmann) Department of Anesthesiology, Amsterdam UMC, Location AMC,
Amsterdam, Netherlands
(Jankovic) Clinic for Anesthesia and Intensive Therapy, Clinical Center
Nis, School of Medicine, University of Nis, Nis, Serbia
(Karzai) Zentralklinik Bad Berka, Bad Berka, Germany
(Krassler) Thoracic Center Coswig, Coswig, Germany
(Loop) Department of Anesthesiology and Intensive Care Medicine Clinic,
Medical Center, University of Freiburg, Faculty of Medicine, University of
Freiburg, Freiburg, Germany
(Licker) University Hospital Geneva, Geneva, Switzerland
(Marczin) Section of Anaesthetics, Pain Medicine and Intensive Care,
Department of Surgery and Cancer, Faculty of Medicine, Imperial College
London, London, United Kingdom
(Marczin) Department of Anaesthesia, Royal Brompton and Harefield NHS
Foundation Trust, Harefield Hospital, Harefield, G-Middlesex, United
Kingdom
(Marczin) Centre of Anaesthesia and Intensive Care, Semmelweis University,
Budapest, Hungary
(Mills) Department of Anaesthesia and Intensive Care Medicine, Sheffield
Teaching Hospitals, Sheffield University, Sheffield, United Kingdom
(Murrell) Department of Anesthesiology, Weill Cornell Medicine, New York,
United States
(Neskovic) Military Medical Academy, Belgrade, Serbia
(Nisnevitch-Savarese) Penn State Hershey Anesthesiology and Perioperative
Medicine, Hershey, United States
(Pelosi) Department of Surgical Sciences and Integrated Diagnostics,
University of Genoa, Genoa, Italy
(Pelosi) IRCCS San Martino Policlinico Hospital, Genoa, Italy
(Rossaint) Department of Anaesthesiology, University Hospital Aachen,
Aachen, Germany
(Schultz) Department of Intensive Care and Laboratory of Experimental
Intensive Care and Anesthesiology, Academic Medical Center, University of
Amsterdam, Amsterdam, Netherlands
(Schultz) Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol
University, Bangkok, Thailand
(Serpa Neto) Department of Critical Care, Hospital Israelita Albert
Einstein, Sao Paulo, Brazil
(Severgnini) Dipartimento di Biotecnologie e Scienze della Vita,
Universita Degli Studi dell'Insubria, Varese, Italy
(Szegedi) Department of Anesthesiology, Centre Hospitalier Universitaire
de Charleroi, Charleroi, Belgium
(Vegh) Department of Anesthesiology and Intensive Care, University of
Debrecen, Debrecen, Hungary
(Vegh) Outcomes Research Consortium, Cleveland, United States
(Voyagis) Department of Anaesthesia, Postoperative ICU, Pain Relief and
Palliative Care Clinic, Sotiria Chest Diseases Hospital, Athens, Greece
(Voyagis) Department of Anaesthesiology and Critical Care Medicine,
University of Patras, Patra, Greece
(Zhong) Department of Anesthesiology, Fudan University Shanghai Cancer
Center, Shanghai, China
(Zhong) Department of Oncology, Shanghai Medical College, Fudan
University, Shanghai, China
(Senturk) Department of Anaesthesiology and Intensive Care, Istanbul
University, Istanbul Medical Faculty, Istanbul, Turkey
Publisher
BioMed Central Ltd
Abstract
Background: Postoperative pulmonary complications (PPC) may result in
longer duration of in-hospital stay and even mortality. Both thoracic
surgery and intraoperative mechanical ventilation settings add
considerably to the risk of PPC. It is unclear if one-lung ventilation
(OLV) for thoracic surgery with a strategy of intraoperative high positive
end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC,
compared to low PEEP without RM. <br/>Method(s): PROTHOR is an
international, multicenter, randomized, controlled, assessor-blinded,
two-arm trial initiated by investigators of the PROtective VEntilation
NETwork. In total, 2378 patients will be randomly assigned to one of two
different intraoperative mechanical ventilation strategies. Investigators
screen patients aged 18 years or older, scheduled for open thoracic or
video-assisted thoracoscopic surgery under general anesthesia requiring
OLV, with a maximal body mass index of 35 kg/m², and a planned
duration of surgery of more than 60 min. Further, the expected duration of
OLV shall be longer than two-lung ventilation, and lung separation is
planned with a double lumen tube. Patients will be randomly assigned to
PEEP of 10 cmH<inf>2</inf>O with lung RM, or PEEP of 5 cmH<inf>2</inf>O
without RM. During two-lung ventilation tidal volume is set at 7 mL/kg
predicted body weight and, during OLV, it will be decreased to 5 mL/kg.
The occurrence of PPC will be recorded as a collapsed composite of single
adverse pulmonary events and represents the primary endpoint.
<br/>Discussion(s): PROTHOR is the first randomized controlled trial in
patients undergoing thoracic surgery with OLV that is adequately powered
to compare the effects of intraoperative high PEEP with RM versus low PEEP
without RM on PPC. The results of the PROTHOR trial will support
anesthesiologists in their decision to set intraoperative PEEP during
protective ventilation for OLV in thoracic surgery. Trial registration:
The trial was registered in clinicaltrials.gov (NCT02963025) on 15
November 2016.<br/>Copyright &#xa9; 2019 The Author(s).

<75>
Accession Number
619230288
Title
Rivaroxaban with or without aspirin in patients with stable coronary
artery disease: an international, randomised, double-blind,
placebo-controlled trial.
Source
The Lancet. 391 (10117) (pp 205-218), 2018. Date of Publication: 20 - 26
January 2018.
Author
Connolly S.J.; Eikelboom J.W.; Bosch J.; Dagenais G.; Dyal L.; Lanas F.;
Metsarinne K.; O'Donnell M.; Dans A.L.; Ha J.-W.; Parkhomenko A.N.; Avezum
A.A.; Lonn E.; Lisheng L.; Torp-Pedersen C.; Widimsky P.; Maggioni A.P.;
Felix C.; Keltai K.; Hori M.; Guzik T.J.; Bhatt D.L.; Branch K.R.H.; Cook
Bruns N.; Berkowitz S.D.; Anand S.S.; Varigos J.D.; Fox K.A.A.; Yusuf S.;
SALA J.; CARTASEGNA L.U.I.S.; VICO M.; HOMINAL M.A.; HASBANI E.; CACCAVO
A.; ZAIDMAN C.; VOGEL D.; HRABAR A.; SCHYGIEL P.O.; CUNEO C.; LUQUEZ
H.U.G.O.; MACKINNON I.J.; AHUAD GUERRERO R.A.; COSTABEL J.P.; BARTOLACCI
I.P.; MONTANA O.; BARBIERI M.; GOMEZ VILAMAJO O.; GARCIA DURAN R.O.;
SCHIAVI L.B.; GARRIDO M.; INGARAMO A.; BORDONAVA A.P.; PELAGAGGE M.J.;
NOVARETTO L.; ALBISU DI GENNERO J.P.; IBANEZ SAGGIA L.M.; ALVAREZ M.; VITA
N.A.; MACIN S.M.; DRAN R.D.; CARDONA M.; GUZMAN L.U.I.S.; SARJANOVICH
R.J.; CUADRADO J.; NANI S.; LITVAK BRUNO M.R.; CHACON C.; MAFFEI L.E.;
GRINFELD D.; VENSENTINI N.; MAJUL C.R.; LUCIARDI H.L.; GONZALEZ COLASO
P.D.C.; FERRE PACORA F.A.; VAN DEN HEUVEL P.A.U.L.; VERHAMME P.; ECTOR
B.A.V.O.; DEBONNAIRE P.; VAN DE BORNE P.; LEROY J.E.A.N.; SCHROE H.;
VRANCKX P.; ELEGEERT I.V.A.N.; HOFFER E.; DUJARDIN K.A.R.L.; INDIO DO
BRASIL C.; PRECOMA D.; ABRANTES J.A.; MANENTI E.; REIS G.; SARAIVA
J.O.S.E.; MAIA L.; HERNANDES M.; ROSSI P.; ROSSI DOS SANTOS F.; ZIMMERMANN
S.L.; RECH R.; ABIB JR E.; LEAES P.; BOTELHO R.; DUTRA O.; SOUZA W.;
BRAILE M.; IZUKAWA N.I.L.O.; NICOLAU J.C.; TANAJURA L.F.; SERRANO JUNIOR
C.V.; MINELLI C.; NASI L.A.; OLIVEIRA L.; DE CARVALHO CANTARELLI M.J.;
TYTUS R.; PANDEY S.; LONN E.V.A.; CHA J.; VIZEL S.A.U.L.; BABAPULLE M.;
LAMY A.; SAUNDERS K.; BERLINGIERI J.; KIAII B.O.B.; BHARGAVA R.; MEHTA P.;
HILL L.; FELL D.; LAM A.N.D.Y.; AL-QOOFI F.; BROWN C.; PETRELLA R.; RICCI
J.A.; GLANZ A.; NOISEUX N.; BAINEY K.; MERALI F.; HEFFERNAN M.; DELLA
SIEGA A.; DAGENAIS G.R.; DAGENAIS F.; BRULOTTE S.; NGUYEN M.; HARTLEIB M.;
GUZMAN R.; BOURGEOIS R.; RUPKA D.; KHAYKIN Y.; GOSSELIN G.; HUYNH
T.H.A.O.; PILON C.; CAMPEAU J.E.A.N.; PICHETTE F.; DIAZ A.; JOHNSTON J.;
SHUKLE P.; HIRSCH G.; RHEAULT P.A.U.L.; CZARNECKI W.; ROY A.; NAWAZ
S.H.A.H.; FREMES S.; SHUKLA D.; JANO G.; COBOS J.L.; CORBALAN R.; MEDINA
M.; NAHUELPAN L.; RAFFO C.; PEREZ L.U.I.S.; POTTHOFF S.; STOCKINS B.;
SEPULVEDA P.; PINCETTI C.; VEJAR M.; TIAN H.; WU X.; KE Y.; JIA K.; YIN
P.; WANG Z.; YU L.; WU S.; WU Z.; LIU S.W.; BAI X.J.; ZHENG Y.A.N.G.; YANG
P.I.N.G.; YANG Y.M.; ZHANG J.; GE J.; CHEN X.P.; HU T.H.; ZHANG R.; ZHENG
Z.H.E.; CHEN X.I.N.; TAO L.; LI J.; HUANG W.; FU G.; LI C.; DONG Y.; WANG
C.; ZHOU X.; KONG Y.E.; SOTOMAYOR A.; ACCINI MENDOZA J.L.; CASTILLO H.;
URINA M.; AROCA G.; PEREZ M.; MOLINA DE SALAZAR D.I.; SANCHEZ VALLEJO G.;
FERNANDO M.J.; GARCIA H.; GARCIA L.H.; ARCOS E.; GOMEZ J.U.A.N.; CUERVO
MILLAN F.; TRUJILLO DADA F.A.; VESGA B.; MORENO SILGADO G.A.; ZIDKOVA
E.V.A.; LUBANDA J.-C.; KALETOVA M.; KRYZA R.; MARCINEK G.; RICHTER M.;
SPINAR J.; MATUSKA J.I.R.I.; TESAK M.; MOTOVSKA Z.; BRANNY M.; MALY
J.I.R.I.; MALY M.; WIENDL M.; FOLTYNOVA CAISOVA L.; SLABY J.; VOJTISEK
P.E.T.R.; PIRK J.A.N.; SPINAROVA L.; BENESOVA M.; CANADYOVA J.; HOMZA M.;
FLORIAN J.; POLASEK R.; COUFAL Z.; SKALNIKOVA V.; BRAT R.; BRTKO M.;
JANSKY P.E.T.R.; LINDNER J.; MARCIAN P.; STRAKA Z.; TRETINA M.; DUARTE
Y.C.; POW CHON LONG F.; SANCHEZ M.; LOPEZ J.O.S.E.; PERUGACHI C.; MARMOL
R.; TRUJILLO F.; TERAN P.; TUOMILEHTO J.; TUOMILEHTO H.; TUOMINEN M.-L.;
KANTOLA I.; STEG G.; ABOYANS V.; LECLERCQ F.; FERRARI E.; BOCCARA F.;
MESSAS E.; MISMETTI P.; SEVESTRE M.A.; CAYLA G.; MOTREFF P.; STOERK S.;
DUENGEN H.A.N.S.-D.I.R.K.; STELLBRINK C.; GUEROCAK O.; KADEL C.;
BRAUN-DULLAEUS R.; JESERICH M.; OPITZ C.; VOEHRINGER H.-F.; APPEL K.-F.;
WINKELMANN B.; DORSEL T.; NIKOL S.; DARIUS H.; RANFT J.; SCHELLONG S.;
JUNGMAIR W.; DAVIERWALA P.; VORPAHL M.A.R.C.; BAJNOK L.; LASZLO Z.; NOORI
E.; VERESS G.; VERTES A.; ZSARY A.; KIS E.R.N.O.; KORANYI L.; BAKAI J.;
BODA Z.; POOR F.; JARAI Z.; KEMENY V.; BARTON J.O.H.N.; MCADAM B.; MURPHY
A.; CREAN P.; MAHON N.; CURTIN R.; MACNEILL B.; DINNEEN S.E.A.N.; HALABI
M.; ZIMLICHMAN R.; ZELTSER D.; TURGEMAN Y.O.A.V.; KLAINMAN E.; LEWIS B.;
KATZ A.M.O.S.; ATAR S.; NIKOLSKY E.; BOSI S.; NALDI M.; FAGGIANO P.; ROBBA
D.; MOS L.; SINAGRA G.; COSMI F.; OLTRONA VISCONTI L.; CARMINE D.M.; DI
PASQUALE G.; DI BIASE M.; MANDORLA S.A.R.A.; BERNARDINANGELI M.; PICCINNI
G.C.; GULIZIA M.M.; GALVANI M.; VENTURI F.; MOROCUTTI G.; BALDIN M.G.;
OLIVIERI C.; PERNA G.P.; CIRRINCIONE V.; KANNO T.; DAIDA H.; OZAKI Y.;
MIYAMOTO N.; HIGASHIUE S.; DOMAE H.; HOSOKAWA S.; KOBAYASHI H.; KURAMOCHI
T.; FUJII K.; MIZUTOMI K.; SAKU K.; KIMURA K.; HIGUCHI Y.; ABE M.; OKUDA
H.; NODA T.; MITA T.; HIRAYAMA A.; ONAKA H.; INOKO M.; HIROKAMI M.; OKUBO
M.; AKATSUKA Y.; IMAMAKI M.; KAMIYA H.; MANITA M.; HIMI T.; UENO H.;
HISAMATSU Y.U.J.I.; AKO J.; NISHINO Y.; KAWAKAMI H.; YAMADA Y.; KORETSUNE
Y.; YAMADA T.; YOSHIDA T.; SHIMOMURA H.; KINOSHITA N.; TAKAHASHI A.;
YUSOFF K.; WAN AHMAD W.A.; ABU HASSAN M.R.; KASIM S.; ABDUL RAHIM A.A.;
MOHD ZAMRIN D.; MACHIDA M.; HIGASHINO Y.; UTSU N.; NAKANO A.; NAKAMURA S.;
HASHIMOTO T.; ANDO K.; SAKAMOTO T.; PRINS F.J.; LOK D.I.R.K.; MILHOUS
J.G.-J.; VIERGEVER E.R.I.C.; WILLEMS F.; SWART H.E.N.K.; ALINGS M.;
BREEDVELD R.O.B.; DE VRIES K.E.E.S.-J.A.N.; VAN DER BORGH R.; OEI F.;
ZOET-NUGTEREN S.; KRAGTEN H.A.N.S.; HERRMAN J.P.; VAN BERGEN P.A.U.L.;
GOSSELINK M.; HOEKSTRA E.; ZEGERS E.; RONNER E.; DEN HARTOG F.; BARTELS
G.; NIEROP P.; VAN DER ZWAAN C.O.E.N.; VAN ECK J.; VAN GORSELEN E.;
GROENEMEIJER B.; HOOGSLAG P.; DE GROOT M.R.; LOYOLA A.; SULIT D.J.; REY
N.; ABOLA M.T.; MORALES D.; PALOMARES E.; ABAT M.E.; ROGELIO G.; CHUA P.;
DEL PILAR J.C.; ALCARAZ J.D.; EBO G.; TIRADOR L.; CRUZ J.; ANONUEVO
J.O.H.N.; PITARGUE A.; JANION M.; GUZIK T.; GAJOS G.; ZABOWKA M.;
RYNKIEWICZ A.; BRONCEL M.; SZUBA A.; CZARNECKA D.; MAGA P.; STRAZHESKO I.;
VASYUK Y.U.R.Y.; SIZOVA Z.; POZDNYAKOV Y.U.R.Y.; BARBARASH O.L.G.A.;
VOEVODA M.; POPONINA T.; REPIN A.; OSIPOVA I.; EFREMUSHKINA A.N.N.A.;
NOVIKOVA N.I.N.A.; AVERKOV O.L.E.G.; ZATEYSHCHIKOV D.; VERTKIN A.; AUSHEVA
A.Z.A.; COMMERFORD P.; SEEDAT S.; VAN ZYL L.; ENGELBRECHT J.A.N.; MAKOTOKO
E.M.; PRETORIUS C.E.; MOHAMED Z.A.I.D.; HORAK A.; MABIN T.; KLUG E.R.I.C.;
BAE J.A.N.G.-H.O.; KIM C.; KIM C.H.O.N.G.-J.I.N.; KIM D.O.N.G.-S.O.O.; KIM
Y.J.; JOO S.; HA J.O.N.G.-W.O.N.; PARK C.S.; KIM J.Y.; KIM
Y.O.U.N.G.-K.W.O.N.; JARNERT C.; MOOE T.; DELLBORG M.; TORSTENSSON I.;
ALBERTSSON P.E.R.; JOHANSSON L.A.R.S.; AL-KHALILI F.; ALMROTH H.;
ANDERSSON T.; PANTEV E.M.I.L.; TENGMARK B.E.N.G.T.-O.L.O.V.; LIU B.O.;
RASMANIS G.; WAHLGREN C.-M.; MOCCETTI T.; PARKHOMENKO A.; TSELUYKO
V.I.R.A.; VOLKOV V.; KOVAL O.; KONONENKO L.; PROKHOROV O.; VDOVYCHENKO V.;
BAZYLEVYCH A.; RUDENKO L.; VIZIR V.; KARPENKO O.; MALYNOVSKY Y.; KOVAL V.;
STOROZHUK B.; COTTON J.; VENKATARAMAN A.S.O.K.; MORIARTY A.; CONNOLLY D.;
DAVEY P.; SENIOR R.O.X.Y.; BIRDI I.; CALVERT J.O.H.N.; DONNELLY P.;
TREVELYAN J.; CARTER J.; PEACE A.; AUSTIN D.; KUKREJA N.; HILTON T.;
SRIVASTAVA S.; WALSH R.; FIELDS R.; HAKAS J.; PORTNAY E.; GOGIA H.;
SALACATA A.; HUNTER J.J.; BACHARACH J.M.; SHAMMAS N.; SURESH D.; SCHNEIDER
R.; GURBEL P.A.U.L.; BANERJEE S.; GRENA P.A.U.L.; BEDWELL N.O.E.L.; SLOAN
S.; LUPOVITCH S.; SONI A.; GIBSON K.; SANGRIGOLI R.; MEHTA R.; I-HSUAN
TSAI P.; GILLESPIE E.V.E.; DEMPSEY S.; HAMROFF G.; BLACK R.; LADER E.;
KOSTIS J.B.; BITTNER V.E.R.A.; MCGUINN W.; BRANCH K.; MALHOTRA V.;
MICHAELSON S.; VACANTE M.; MCCORMICK M.; ARIMIE R.; CAMP A.L.A.N.; DAGHER
G.; KOSHY N.M.; THEW S.; COSTELLO F.; HEIMAN M.A.R.K.; CHILTON R.; MORAN
M.; ADLER F.; COMEROTA A.; SEIWERT A.; FRENCH W.; SEROTA H.; HARRISON R.;
BAKAEEN F.; OMER S.; CHANDRA L.; WHELAN A.L.A.N.; BOYLE A.;
ROBERTS-THOMSON P.; ROGERS J.; CARROLL P.; COLQUHOUN D.; SHAW J.; BLOMBERY
P.; AMERENA J.O.H.N.; HII C.; ROYSE A.; SINGH B.; SELVANAYAGAM J.; JANSEN
S.; LO W.; HAMMETT C.; POULTER R.; NARASIMHAN S.; WIGGERS H.; NIELSEN H.;
GISLASON G.; KOBER L.A.R.S.; HOULIND K.I.M.; BOENELYKKE SOERENSEN V.;
DIXEN U.; REFSGAARD J.E.N.S.; ZEUTHEN E.; SOEGAARD P.; HRANAI M.; GASPAR
L.; PELLA D.; HATALOVA K.; DROZDAKOVA E.; COMAN I.O.A.N.; DIMULESCU D.;
VINEREANU D.; CINTEZA M.; SINESCU C.; ARSENESCU C.; BENEDEK I.M.R.E.;
BOBESCU E.; DOBREANU D.A.N.; GAITA D.A.N.; IANCU A.; ILIESIU A.; LIGHEZAN
D.; PETRESCU L.; PIRVU O.; TEODORESCU I.; TESLOIANU D.A.N.; VINTILA M.M.;
CHIONCEL O.
Institution
(Connolly, Eikelboom, Dyal, Lonn, Anand, Yusuf) Population Health Research
Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON,
Canada
(Bosch) School of Rehabilitation Science, McMaster University, Hamilton,
ON, Canada
(Dagenais) Institut Universitaire de Cardiologie et Pneumologie de Quebec,
Quebec, QC, Canada
(Lanas) Universidad de la Frontera, Temuco, Chile
(Metsarinne) Department of Medicine, Turku University Central Hospital and
Turku University, Turku, Finland
(O'Donnell) Department of Medicine, National University of Ireland,
Galway, Ireland
(Dans) Department of Medicine, University of Philippines, Manila,
Philippines
(Ha) Yonsei University College of Medicine, Seoul, South Korea
(Parkhomenko) Institute of Cardiology, Kiev, Ukraine
(Avezum) Instituto Dante Pazzanese de Cardiologia & University Santo
Amaro, Sao Paulo, Brazil
(Lisheng) FuWai Hospital, CAMS, Beijing, China
(Torp-Pedersen) University of Aalborg, Aalborg, Denmark
(Widimsky) Charles University, Prague, Czechia
(Maggioni) ANMCO Research Center, Florence, Italy
(Felix) Universidad Tecnologica Equinoccial, Facultad de Ciencias de la
Salud Eugenio, Espejo, Quito, Ecuador
(Keltai) Department of Medicine, Semmelweis University, Budapest, Hungary
(Hori) Osaka International Cancer Institute, Osaka, Japan
(Yusoff) Universiti Teknologi Mara, Selangor, Malaysia
(Guzik) Collegium Medicum Jagiellonian University, Krakow, Poland
(Guzik) University of Glasgow, Glasgow, United Kingdom
(Bhatt) Brigham and Women's Hospital Heart & Vascular Center and Harvard
Medical School, Boston, MA, United States
(Branch) Department of Medicine, University of Washington Medical Centre,
Seattle, WA, United States
(Cook Bruns) Bayer AG, Wuppertal, Germany
(Berkowitz) Bayer AG, Parsippany, NJ, United States
(Varigos) Monash University, Melbourne, VIC, Australia
(Fox) Department of Medicine, University of Edinburgh, Edinburgh, United
Kingdom
Publisher
Lancet Publishing Group
Abstract
Background: Coronary artery disease is a major cause of morbidity and
mortality worldwide, and is a consequence of acute thrombotic events
involving activation of platelets and coagulation proteins. Factor Xa
inhibitors and aspirin each reduce thrombotic events but have not yet been
tested in combination or against each other in patients with stable
coronary artery disease. <br/>Method(s): In this multicentre,
double-blind, randomised, placebo-controlled, outpatient trial, patients
with stable coronary artery disease or peripheral artery disease were
recruited at 602 hospitals, clinics, or community centres in 33 countries.
This paper reports on patients with coronary artery disease. Eligible
patients with coronary artery disease had to have had a myocardial
infarction in the past 20 years, multi-vessel coronary artery disease,
history of stable or unstable angina, previous multi-vessel percutaneous
coronary intervention, or previous multi-vessel coronary artery bypass
graft surgery. After a 30-day run in period, patients were randomly
assigned (1:1:1) to receive rivaroxaban (2.5 mg orally twice a day) plus
aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day),
or aspirin alone (100 mg orally once a day). Randomisation was computer
generated. Each treatment group was double dummy, and the patients,
investigators, and central study staff were masked to treatment
allocation. The primary outcome of the COMPASS trial was the occurrence of
myocardial infarction, stroke, or cardiovascular death. This trial is
registered with ClinicalTrials.gov, number NCT01776424, and is closed to
new participants. <br/>Finding(s): Between March 12, 2013, and May 10,
2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824
patients had stable coronary artery disease from 558 centres. The
combination of rivaroxaban plus aspirin reduced the primary outcome more
than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio
[HR] 0.74, 95% CI 0.65-0.86, p<0.0001). By comparison, treatment with
rivaroxaban alone did not significantly improve the primary outcome when
compared with treatment with aspirin alone (411 [5%] of 8250 vs 460 [6%]
of 8261; HR 0.89, 95% CI 0.78-1.02, p=0.094). Combined rivaroxaban plus
aspirin treatment resulted in more major bleeds than treatment with
aspirin alone (263 [3%] of 8313 vs 158 [2%] of 8261; HR 1.66, 95% CI
1.37-2.03, p<0.0001), and similarly, more bleeds were seen in the
rivaroxaban alone group than in the aspirin alone group (236 [3%] of 8250
vs 158 [2%] of 8261; HR 1.51, 95% CI 1.23-1.84, p<0.0001). The most common
site of major bleeding was gastrointestinal, occurring in 130 [2%]
patients who received combined rivaroxaban plus aspirin, in 84 [1%]
patients who received rivaroxaban alone, and in 61 [1%] patients who
received aspirin alone. Rivaroxaban plus aspirin reduced mortality when
compared with aspirin alone (262 [3%] of 8313 vs 339 [4%] of 8261; HR
0.77, 95% CI 0.65-0.90, p=0.0012). <br/>Interpretation(s): In patients
with stable coronary artery disease, addition of rivaroxaban to aspirin
lowered major vascular events, but increased major bleeding. There was no
significant increase in intracranial bleeding or other critical organ
bleeding. There was also a significant net benefit in favour of
rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of
rivaroxaban to aspirin has the potential to substantially reduce morbidity
and mortality from coronary artery disease worldwide. <br/>Funding(s):
Bayer AG.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<76>
Accession Number
619144063
Title
Drug-eluting stents in elderly patients with coronary artery disease
(SENIOR): a randomised single-blind trial.
Source
The Lancet. 391 (10115) (pp 41-50), 2018. Date of Publication: 6 - 12
January 2018.
Author
Varenne O.; Cook S.; Sideris G.; Kedev S.; Cuisset T.; Carrie D.; Hovasse
T.; Garot P.; El Mahmoud R.; Spaulding C.; Helft G.; Diaz Fernandez J.F.;
Brugaletta S.; Pinar-Bermudez E.; Mauri Ferre J.; Commeau P.; Teiger E.;
Bogaerts K.; Sabate M.; Morice M.-C.; Sinnaeve P.R.
Institution
(Varenne) Hopital Cochin, Assistance Publique-Hopitaux de Paris, Paris,
France
(Varenne) Cardiology Department, Universite Paris Descartes, Sorbonne
Paris-Cite, Paris, France
(Cook) Cardiology Department, University and Hospital Fribourg, Fribourg,
Switzerland
(Sideris) Service de Cardiologie-Institut national de la sante et de la
recherche medicale U942, Hopital Lariboisiere, Assistance Publique -
Hopitaux de Paris, Universite Paris Diderot, Paris, France
(Kedev) Cardiology Department, University St Cyril and Methodius, Skopje,
North Macedonia
(Cuisset) Departement de Cardiologie, Centre hospitalier universitaire
Timone, Marseille, France
(Carrie) Service de Cardiologie, Centre hospitalier universitaire Toulouse
Rangueil, Universite Paul Sabatier, Toulouse, France
(Hovasse, Garot) Institut Cardiovasculaire Paris-Sud, Ramsay Generale de
Sante, Massy and Quincy, France
(El Mahmoud) Hopital Ambroise Pare Assistance Publique-Hopitaux de Paris,
Universite Versailles-Saint Quentin en Yvelines, Versailles, France
(Spaulding) Service de Cardiologie, Hopital Europeen Georges Pompidou,
Assistance Publique-Hopitaux de Paris, Paris Descartes University and
Sudden Death Expert Center, Institut national de la sante et de la
recherche medicale U990, Paris, France
(Helft) Institut de Cardiologie, Hopital Pitie-Salpetriere, Assistance
Publique-Hopitaux de Paris, Universite Pierre et Marie Curie et Institut
hospitalo-universitaire, Institute of Cardiometabolism and Nutrition,
Hopital Pitie-Salpetriere, Paris, France
(Diaz Fernandez) Juan Ramon Jimenez University Hospital, Huelva, Spain
(Brugaletta) Cardiovascular Institute, Hospital Clinic, Institut
d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain
(Pinar-Bermudez) Hospital Universitario Virgen de la Arrixaca, Murcia,
Spain
(Mauri Ferre) Hospital Universitari Germans Trias i Pujol, Badalona, Spain
(Commeau) Departement de Cardiologie Interventionnelle, Polyclinique Les
Fleurs, Ollioules, France
(Teiger) Service de Cardiologie, Hopital Henri Mondor Assistance
Publique-Hopitaux de Paris, Universite Paris Est Creteil, Creteil, France
(Bogaerts) Interuniversity Institute for Biostatistics and Statistical
Bioinformatics (I-BioStat), Department of Public Health and Primary Care,
Katholieke Universiteit Leuven, Leuven, Belgium
(Bogaerts) Interuniversity Institute for Biostatistics and Statistical
Bioinformatics (I-BioStat), University Hasselt, Hasselt, Belgium
(Sabate) Interventional Cardiology Unit, Cardiovascular Institute,
Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer,
Barcelona, Spain
(Morice) Cardiovascular European Research Center, Massy, France
(Sinnaeve) Department of Cardiovascular Medicine, University Hospitals
Leuven, Leuven, Belgium
Publisher
Lancet Publishing Group
Abstract
Background: Elderly patients regularly receive bare-metal stents (BMS)
instead of drug-eluting stents (DES) to shorten the duration of double
antiplatelet therapy (DAPT). The aim of this study was to compare outcomes
between these two types of stents with a short duration of DAPT in such
patients. <br/>Method(s): In this randomised single-blind trial, we
recruited patients from 44 centres in nine countries. Patients were
eligible if they were aged 75 years or older; had stable angina, silent
ischaemia, or an acute coronary syndrome; and had at least one coronary
artery with a stenosis of at least 70% (>=50% for the left main stem)
deemed eligible for percutaneous coronary intervention (PCI). Exclusion
criteria were indication for myocardial revascularisation by coronary
artery bypass grafting; inability to tolerate, obtain, or comply with
DAPT; requirement for additional surgery; non-cardiac comorbidities with a
life expectancy of less than 1 year; previous haemorrhagic stroke; allergy
to aspirin or P2Y<inf>12</inf> inhibitors; contraindication to
P2Y<inf>12</inf> inhibitors; and silent ischaemia of less than 10% of the
left myocardium with a fractional flow reserve of 0.80 or higher. After
the intended duration of DAPT was recorded (1 month for patients with
stable presentation and 6 months for those with unstable presentation),
patients were randomly allocated (1:1) by a central computer system
(blocking used with randomly selected block sizes [two, four, eight, or
16]; stratified by site and antiplatelet agent) to either a DES or similar
BMS in a single-blind fashion (ie, patients were masked), but those
assessing outcomes were masked. The primary outcome was to compare major
adverse cardiac and cerebrovascular events (ie, a composite of all-cause
mortality, myocardial infarction, stroke, or ischaemia-driven target
lesion revascularisation) between groups at 1 year in the
intention-to-treat population, assessed at 30 days, 180 days, and 1 year.
This trial is registered with ClinicalTrials.gov, number NCT02099617.
<br/>Finding(s): Between May 21, 2014, and April 16, 2016, we randomly
assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the
BMS group). The primary endpoint occurred in 68 (12%) patients in the DES
group and 98 (16%) in the BMS group (relative risk [RR] 0.71 [95% CI
0.52-0.94]; p=0.02). Bleeding complications (26 [5%] in the DES group vs
29 [5%] in the BMS group; RR 0.90 [0.51-1.54]; p=0.68) and stent
thrombosis (three [1%] vs eight [1%]; RR 0.38 [0.00-1.48]; p=0.13) at 1
year were infrequent in both groups. <br/>Interpretation(s): Among elderly
patients who have PCI, a DES and a short duration of DAPT are better than
BMS and a similar duration of DAPT with respect to the occurrence of
all-cause mortality, myocardial infarction, stroke, and ischaemia-driven
target lesion revascularisation. A strategy of combination of a DES to
reduce the risk of subsequent repeat revascularisations with a short
BMS-like DAPT regimen to reduce the risk of bleeding event is an
attractive option for elderly patients who have PCI. <br/>Funding(s):
Boston Scientific.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<77>
Accession Number
2001132716
Title
Radial versus femoral access and bivalirudin versus unfractionated heparin
in invasively managed patients with acute coronary syndrome (MATRIX):
final 1-year results of a multicentre, randomised controlled trial.
Source
The Lancet. 392 (10150) (pp 835-848), 2018. Date of Publication: 8 - 14
September 2018.
Author
Valgimigli M.; Frigoli E.; Leonardi S.; Vranckx P.; Rothenbuhler M.;
Tebaldi M.; Varbella F.; Calabro P.; Garducci S.; Rubartelli P.; Briguori
C.; Ando G.; Ferrario M.; Limbruno U.; Garbo R.; Sganzerla P.; Russo F.;
Nazzaro M.; Lupi A.; Cortese B.; Ausiello A.; Ierna S.; Esposito G.;
Ferrante G.; Santarelli A.; Sardella G.; de Cesare N.; Tosi P.; van 't Hof
A.; Omerovic E.; Brugaletta S.; Windecker S.; Heg D.; Juni P.; Campo G.;
Uguccioni L.; Tamburino C.; Presbitero P.; Zavalloni-Parenti D.; Ferrari
F.; Ceravolo R.; Tarantino F.; Pasquetto G.; Casu G.; Mameli S.; Stochino
M.L.; Mazzarotto P.; Cremonesi A.; Saia F.; Saccone G.; Abate F.; Picchi
A.; Violini R.; Colangelo S.; Boccuzzi G.; Guiducci V.; Vigna C.;
Zingarelli A.; Gagnor A.; Zaro T.; Tresoldi S.; Vandoni P.; Contarini M.;
Liso A.; Dellavalle A.; Curello S.; Mangiacapra F.; Evola R.; Palmieri C.;
Falcone C.; Liistro F.; Creaco M.; Colombo A.; Chieffo A.; Perkan A.; De
Servi S.; Fischetti D.; Rigattieri S.; Sciahbasi A.; Pucci E.; Romagnoli
E.; Moretti C.; Moretti L.; De Caterina R.; Caputo M.; Zimmarino M.;
Bramucci E.; Di Lorenzo E.; Turturo M.; Bonmassari R.; Penzo C.; Loi B.;
Mauro C.; Petronio A.S.; Gabrielli G.; Micari A.; Belloni F.; Amico F.;
Comeglio M.; Fresco C.; Klinieken I.; Van Mieghem N.; Diletti R.; Regar
E.; Sabate M.; Gomez Hospital J.A.; Diaz Fernandez J.F.; Mainar V.; de la
Torre Hernandez J.M.
Institution
(Valgimigli, Windecker) Inselspital, Bern University Hospital, University
of Bern, Bern, Switzerland
(Frigoli, Rothenbuhler, Heg) Clinical Trials Unit, University of Bern,
Bern, Switzerland
(Leonardi, Ferrario) UOC Cardiologia, Dipartimento CardioToracoVascolare,
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
(Vranckx) Department of Cardiology and Critical Care Medicine, Hartcentrum
Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
(Tebaldi) University Hospital of Ferrara, Ferrara, Italy
(Varbella) Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3,
Turin, Italy
(Calabro) Division of Clinical Cardiology, "Sant'Anna e San Sebastiano"
Hospital, Caserta, Italy
(Calabro) Department of Translational Medical Sciences, University of
Campania "Luigi Vanvitelli", Naples, Italy
(Garducci) A.O. Ospedale Civile di Vimercate, Vimercate, Italy
(Rubartelli) Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa,
Italy
(Briguori) Clinica Mediterranea, Naples, Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino",
University of Messina, Messina, Italy
(Limbruno) UO Cardiologia, ASL 9 Grosseto, Grosseto, Italy
(Garbo) San Giovanni Bosco Hospital, Turin, Italy
(Sganzerla) AO Ospedale Treviglio-Caravaggio, Treviglio, Italy
(Russo) Azienda Ospedaliera Sant'Anna, Como, Italy
(Nazzaro) San Camillo-Forlanini, Roma, Italy
(Lupi) Division of Cardiology, ASL VCO, Verbania, Italy
(Cortese) Ospedale FatebeneFratelli, Milano, Italy
(Ausiello) Casa di Cura Villa Verde, Taranto, Italy
(Ierna) Ospedale Sirai, Carbonia, Carbonia, Italy
(Esposito) Division of Cardiology, Department of Advanced Biomedical
Sciences, Federico II University of Naples, Naples, Italy
(Ferrante) IRCCS Humanitas, Milan, Italy
(Santarelli) Cardiovascular Department, Infermi Hospital, Rimini, Italy
(Sardella) Policlinico Umberto I, "Sapienza" University of Rome, Rome,
Italy
(de Cesare) Policlinico San Marco, Zingonia, Italy
(Tosi) Mater Salutis Hospital, Legnago, Italy
(van 't Hof) Department of Cardiology, Maastricht University Medical
Center (MUMC+), Maastricht, Netherlands
(Omerovic) Sahlgrenska University Hospital, Gothenburg, Sweden
(Brugaletta) Hospital Clinic, University of Barcelona, Thorax Institute,
Department of Cardiology, Barcelona, Spain
(Juni) Applied Health Research Centre (AHRC), Li Ka Shing Knowledge
Institute of St Michael's Hospital, Department of Medicine and Institute
of Health Policy, Management and Evaluation, University of Toronto,
Toronto, ON, Canada
Publisher
Lancet Publishing Group
Abstract
Background: The Minimizing Adverse Haemorrhagic Events by Transradial
Access Site and Systemic Implementation of Angiox (MATRIX) programme was
designed to assess the comparative safety and effectiveness of radial
versus femoral access and of bivalirudin versus unfractionated heparin
with optional glycoprotein IIb/IIIa inhibitors in patients with the whole
spectrum of acute coronary syndrome undergoing invasive management. Here
we describe the prespecified final 1-year outcomes of the entire
programme. <br/>Method(s): MATRIX was a programme of three nested,
randomised, multicentre, open-label, superiority trials in patients with
acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain,
and Sweden. Patients with ST-elevation myocardial infarction were
simultaneously randomly assigned (1:1) before coronary angiography to
radial or femoral access and to bivalirudin, with or without
post-percutaneous coronary intervention infusion or unfractionated heparin
(one-step inclusion). Patients with non-ST-elevation acute coronary
syndrome were randomly assigned (1:1) before coronary angiography to
radial or femoral access and, only if deemed eligible to percutaneous
coronary intervention after angiography (two-step inclusion), entered the
antithrombin type and treatment duration programmes. Randomisation
sequences were computer generated, blocked, and stratified by intended new
or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or
prasugrel), and acute coronary syndrome type (ST-elevation myocardial
infarction, troponin-positive, or troponin-negative non-ST-elevation acute
coronary syndrome). Bivalirudin was given as a bolus of 0.75 mg/kg,
followed immediately by an infusion of 1.75 mg/kg per h until completion
of percutaneous coronary intervention. Heparin was given at 70-100 units
per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at
50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors.
Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for
MATRIX access and MATRIX antithrombin type were major adverse
cardiovascular events, defined as the composite of all-cause mortality,
myocardial infarction, or stroke up to 30 days; and net adverse clinical
events, defined as the composite of non-coronary artery bypass
graft-related major bleeding, or major adverse cardiovascular events up to
30 days. The primary outcome for MATRIX treatment duration was the
composite of urgent target vessel revascularisation, definite stent
thrombosis, or net adverse clinical events up to 30 days. Analyses were
done according to the intention-to-treat principle. This trial is
registered with ClinicalTrials.gov, number NCT01433627. <br/>Finding(s):
Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients
to receive radial (4197 patients) or femoral (4207 patients) access. Of
these 8404 patients, 7213 were included in the MATRIX antithrombin type
study and were randomly assigned to bivalirudin (3610 patients) or heparin
(3603 patients). Patients assigned to bivalirudin were included in the
MATRIX treatment duration study, and were randomly assigned to
post-procedure infusion (1799 patients) or no post-procedure infusion
(1811 patients). At 1 year, major adverse cardiovascular events did not
differ between patients assigned to radial access compared with those
assigned to femoral access (14.2% vs 15.7%; rate ratio 0.89, 95% CI
0.80-1.00; p=0.0526), but net adverse clinical events were fewer with
radial than with femoral access (15.2% vs 17.2%; 0.87, 0.78-0.97;
p=0.0128). Compared with heparin, bivalirudin was not associated with
fewer major adverse cardiovascular (15.8% vs 16.8%; 0.94, 0.83-1.05;
p=0.28) or net adverse clinical events (17.0% vs 18.4%; 0.91, 0.81-1.02;
p=0.10). The composite of urgent target vessel revascularisation, stent
thrombosis, or net adverse clinical events did not differ with or without
post-procedure bivalirudin infusion (17.4% vs 17.4%; 0.99, 0.84-1.16;
p=0.90). <br/>Interpretation(s): In patients with acute coronary syndrome,
radial access was associated with lower rates of net adverse clinical
events compared with femoral access, but not major adverse cardiovascular
events at 1 year. Bivalirudin with or without post-procedure infusion was
not associated with lower rates of major adverse cardiovascular events or
net adverse clinical events. Radial access should become the default
approach in acute coronary syndrome patients undergoing invasive
management. <br/>Funding(s): Italian Society of Invasive Cardiology, The
Medicines Company, Terumo, amd Canada Research Chairs
Programme.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<78>
Accession Number
2000825445
Title
Dabigatran in patients with myocardial injury after non-cardiac surgery
(MANAGE): an international, randomised, placebo-controlled trial.
Source
The Lancet. 391 (10137) (pp 2325-2334), 2018. Date of Publication: 09 Jun
2018.
Author
Devereaux P.J.; Duceppe E.; Guyatt G.; Tandon V.; Rodseth R.; Biccard
B.M.; Xavier D.; Szczeklik W.; Meyhoff C.S.; Vincent J.; Franzosi M.G.;
Srinathan S.K.; Erb J.; Magloire P.; Neary J.; Rao M.; Rahate P.V.;
Chaudhry N.K.; Mayosi B.; de Nadal M.; Iglesias P.P.; Berwanger O.; Villar
J.C.; Botto F.; Eikelboom J.W.; Sessler D.I.; Kearon C.; Pettit S.;
Connolly S.J.; Bangdiwala S.I.; Rao-Melacini P.; Hoeft A.; Yusuf S.;
Connolly S.; Eikelboom J.; Pogue J.; Di Diodato S.; Gasic Z.; Mastrangelo
L.J.; Molnar S.H.; Swanson J.L.; Tosh M.L.; Wells J.R.; Diaz R.; Chow
C.K.; Gonzales B.; Vasquez S.; Jansky P.; Dusek R.; Coriat P.; Wittmann
M.; Yonga G.; Mathur N.; Seletti E.; Malaga G.; Tumanan-Mendoza B.A.;
Tagle M.P.A.; Alonso-Coello P.; Popova E.; Shields M.; Le Manach Y.;
Moayyedi P.; van Zanten S.; Fleischmann E.; Garg A.; Karaye K.; McFalls
E.; Sigamani A.; Belley-Cote E.; Biedron G.; Borges F.; Frosi Stella S.;
Haarmark Nielsen C.; Leong D.P.; Spence J.; Tran A.; Wawrzycka-Adamczyk
K.; Yang S.S.; Yung T.; Wyse D.G.; Cheng D.; Johnstone D.E.; Wells G.A.;
Joseph P.; Patel A.; Gregus K.; Lawrence K.; Doharris L.; Conen D.; Cheung
J.; Douketis J.; Wright D.; Wikkerink S.; Dechert W.; Panju M.; Azzam K.;
Rapanos T.; Van Helder T.; Shroff A.; Hare J.; Kidane B.; Nguyen T.;
Leydier L.; Bayaraa V.; Parlow J.; DuMerton D.A.; Thakrar A.; Shelley J.;
Deligne B.; Carling R.D.; Mrkobrada M.; Dresser G.K.; Jacka M.J.;
Hornstein D.; Winkelaar G.B.; Haider Z.H.; Lanjewar P.P.; Varughese V.;
Calton R.; Ahuja H.; George P.; Sharma A.; Bhatt K.S.; Mangukiya D.O.;
Nandaniya K.V.; Parekh V.V.; Pillai A.B.; Menon V.P.; Desai S.C.; Sidhu
R.S.; Gupta S.K.; George R.K.; Gurunath T.R.; Drummond L.W.; Torborg A.M.;
Kusel B.S.; Naidoo P.; Naidoo D.P.; Rajah C.; Farina Z.; von Rahden R.P.;
Gumede S.; Chishala C.; Coetzee E.; Dyer R.A.; Diedericks J.; Bielanski
P.; Kaczmarek B.; Studzinska D.; Zaniewski M.; Libura M.J.;
Zacharias-Nalichowski T.M.; Sega A.A.S.; Salwa J.; Kozka M.; Gorka J.;
Wludarczyk A.; Nowak-Kozka I.; Grudzien P.S.; Gucwa J.W.; Slowiaczek M.P.;
Dobosz P.P.D.; Gogenur I.; Eriksen J.R.; Borup T.; Kirkegaard T.; Isbye
D.; Sonne A.; Rasmussen L.S.; Pedersen S.; Troensegaard H.; Duus C.L.;
Halle B.M.; Gundel O.N.; Bernholm K.F.; Martinsen K.R.; Itenov T.S.; Camio
E.; Vazquez C.; Matarin S.; Cano E.; Alvarez-Garcia J.; India I.;
Gonzalez-Osuna A.; Vives M.; Rossello E.; Serrano A.B.; Turiel M.; Drago
L.; Colombo C.; Marra F.; Mos L.; Arteni F.; Lembo R.; Ortalda A.;
Passarani S.; Mokini Z.; Figueiredo E.L.; Werner G.F.; Petriz J.L.; Maia
L.N.; Bergo R.R.; Precoma D.B.; Saraiva J.F.K.; Vilamajo O.G.; Allegrini
E.; Benzadon M.; Parody M.L.; Duronto E.A.; Ingaramo A.C.; Parra G.A.;
Novoa D.; Miller S.A.; Thomas S.; Karlapudi S.P.; Bourji M.H.; Banerjee
S.; Gupta A.; Opole I.O.; Fischer M.; Mendoza V.L.; Reyes E.B.; Pierson
R.J.; Shields M.O.; Piriou V.; Zacharowski K.; Rotta-Rotta A.; Paper M.;
Rahate P.; Chaudhry N.; Paniagua Iglesias P.; Sharma M.
Institution
(Devereaux, Duceppe, Guyatt, Kearon, Bangdiwala, Yusuf) Department of
Health Research Methods, Evidence, and Impact, McMaster University,
Hamilton, ON, Canada
(Devereaux, Guyatt, Tandon, Magloire, Neary, Eikelboom, Kearon, Sharma,
Connolly, Yusuf) Department of Medicine, McMaster University, Hamilton,
ON, Canada
(Devereaux, Vincent, Pettit, Sharma, Connolly, Bangdiwala, Rao-Melacini,
Yusuf) Population Health Research Institute, Hamilton, ON, Canada
(Duceppe) Department of Medicine, University of Montreal, Montreal, QC,
Canada
(Rodseth) Department of Anaesthesia, University of KwaZulu-Natal,
Pietermaritzburg, South Africa
(Biccard) Department of Anaesthesia and Perioperative Medicine, Groote
Schuur Hospital and University of Cape Town, Cape Town, South Africa
(Mayosi) Department of Medicine, Groote Schuur Hospital and University of
Cape Town, Cape Town, South Africa
(Xavier, Rao) Department of Pharmacology, St John's Medical College and
Research Institute, Bangalore, India
(Szczeklik) Department of Intensive Care and Perioperative Medicine,
Jagiellonian University Medical College, Krakow, Poland
(Meyhoff) Department of Anaesthesia and Intensive Care, Bispebjerg and
Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark
(Franzosi) Department of Cardiovascular Research, IRCCS Istituto di
Ricerche Farmacologiche Mario Negri, Milan, Italy
(Srinathan) Department of Surgery, University of Manitoba, Winnipeg, MB,
Canada
(Erb) Department of Anesthesiology and Perioperative Medicine, Queen's
University, Kingston, ON, Canada
(Rahate) Department of Surgery, Rahate Surgical Hospital, Nagpur, India
(Chaudhry) Department of Surgery, Christian Medical College Hospital,
Ludhiana, India
(de Nadal) Department of Anesthesiology, Hospital Universitari Vall
d'Hebron, Barcelona, Spain
(Iglesias) Department of Anesthesiology, Hospital de la Santa Creu i Sant
Pau, Barcelona, Spain
(Berwanger) Instituto de Ensino e Pesquisa do Hospital do Coracao
(IEP-HCor), Sao Paulo, Brazil
(Villar) Departamento de Investigaciones, Fundacion
Cardioinfantil-Instituto de Cardiologia (Bogota) and Facultad de Ciencias
de la Salud, Universidad Autonoma de Bucaramanga, Colombia
(Botto) Estudios Clinicos Latinoamerica (ECLA), Rosario and Hospital
Austral, Pilar, Argentina
(Sessler) Department of Outcomes Research, Cleveland Clinic,
Anesthesiology Institute, Cleveland, OH, United States
(Hoeft) Department of Anesthesiology and Intensive Care Medicine,
University Hospital Bonn, Bonn, Germany
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: Myocardial injury after non-cardiac surgery (MINS) increases
the risk of cardiovascular events and deaths, which anticoagulation
therapy could prevent. Dabigatran prevents perioperative venous
thromboembolism, but whether this drug can prevent a broader range of
vascular complications in patients with MINS is unknown. The MANAGE trial
assessed the potential of dabigatran to prevent major vascular
complications among such patients. <br/>Method(s): In this international,
randomised, placebo-controlled trial, we recruited patients from 84
hospitals in 19 countries. Eligible patients were aged at least 45 years,
had undergone non-cardiac surgery, and were within 35 days of MINS.
Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally
twice daily or matched placebo for a maximum of 2 years or until
termination of the trial and, using a partial 2-by-2 factorial design,
patients not taking a proton-pump inhibitor were also randomly assigned
(1:1) to omeprazole 20 mg once daily, for which results will be reported
elsewhere, or matched placebo to measure its effect on major upper
gastrointestinal complications. Research personnel randomised patients
through a central 24 h computerised randomisation system using block
randomisation, stratified by centre. Patients, health-care providers, data
collectors, and outcome adjudicators were masked to treatment allocation.
The primary efficacy outcome was the occurrence of a major vascular
complication, a composite of vascular mortality and non-fatal myocardial
infarction, non-haemorrhagic stroke, peripheral arterial thrombosis,
amputation, and symptomatic venous thromboembolism. The primary safety
outcome was a composite of life-threatening, major, and critical organ
bleeding. Analyses were done according to the intention-to-treat
principle. This trial is registered with ClinicalTrials.gov, number
NCT01661101. <br/>Finding(s): Between Jan 10, 2013, and July 17, 2017, we
randomly assigned 1754 patients to receive dabigatran (n=877) or placebo
(n=877); 556 patients were also randomised in the omeprazole partial
factorial component. Study drug was permanently discontinued in 401 (46%)
of 877 patients allocated to dabigatran and 380 (43%) of 877 patients
allocated to placebo. The composite primary efficacy outcome occurred in
fewer patients randomised to dabigatran than placebo (97 [11%] of 877
patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to
placebo; hazard ratio [HR] 0.72, 95% CI 0.55-0.93; p=0.0115). The primary
safety composite outcome occurred in 29 patients (3%) randomised to
dabigatran and 31 patients (4%) randomised to placebo (HR 0.92, 95% CI
0.55-1.53; p=0.76). <br/>Interpretation(s): Among patients who had MINS,
dabigatran 110 mg twice daily lowered the risk of major vascular
complications, with no significant increase in major bleeding. Patients
with MINS have a poor prognosis; dabigatran 100 mg twice daily has the
potential to help many of the 8 million adults globally who have MINS to
reduce their risk of a major vascular complication. <br/>Funding(s):
Boehringer Ingelheim and Canadian Institutes of Health
Research.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<79>
Accession Number
2000461742
Title
Mortality after coronary artery bypass grafting versus percutaneous
coronary intervention with stenting for coronary artery disease: a pooled
analysis of individual patient data.
Source
The Lancet. 391 (10124) (pp 939-948), 2018. Date of Publication: 10 - 16
March 2018.
Author
Head S.J.; Milojevic M.; Daemen J.; Ahn J.-M.; Boersma E.; Christiansen
E.H.; Domanski M.J.; Farkouh M.E.; Flather M.; Fuster V.; Hlatky M.A.;
Holm N.R.; Hueb W.A.; Kamalesh M.; Kim Y.-H.; Makikallio T.; Mohr F.W.;
Papageorgiou G.; Park S.-J.; Rodriguez A.E.; Sabik J.F.; Stables R.H.;
Stone G.W.; Serruys P.W.; Kappetein A.P.
Institution
(Head, Milojevic, Papageorgiou, Kappetein) Department of Cardiothoracic
Surgery, Erasmus University Medical Center, Rotterdam, Netherlands
(Daemen, Boersma) Department of Cardiology, Erasmus University Medical
Center, Rotterdam, Netherlands
(Papageorgiou) Department of Biostatistics, Erasmus University Medical
Center, Rotterdam, Netherlands
(Ahn, Kim, Park) Department of Cardiology, University of Ulsan College of
Medicine, Asan Medical Center, Seoul, South Korea
(Christiansen, Holm) Department of Cardiology, Aarhus University Hospital,
Skejby, Aarhus, Denmark
(Domanski, Farkouh, Fuster) Icahn School of Medicine at Mount Sinai, New
York, NY, United States
(Domanski, Farkouh) Peter Munk Cardiac Centre and the Heart and Stroke
Richard Lewar Centre, University of Toronto, Toronto, ON, Canada
(Flather) Norwich Medical School University of East Anglia and Norfolk and
Norwich University Hospital, Norwich, United Kingdom
(Hlatky) Stanford University School of Medicine, Stanford, CA, United
States
(Hueb) Heart Institute (InCor), University of Sao Paulo Medical School,
Sao Paulo, Brazil
(Kamalesh) Richard L Roudebush VA Medical Center, Indianapolis, IN, United
States
(Makikallio) Department of Cardiology, Oulu University Hospital, Oulu,
Finland
(Mohr) Department of Cardiac Surgery, Herzzentrum Universitat Leipzig,
Leipzig, Germany
(Rodriguez) Cardiac Unit, Otamendi Hospital, Buenos Aires, Argentina
(Sabik) Department Surgery, University Hospitals Cleveland Medical Center,
Cleveland, OH, United States
(Stables) Institute of Cardiovascular Medicine and Science, Liverpool
Heart and Chest Hospital, Liverpool, United Kingdom
(Stone) Columbia University Medical Center and the Center for Clinical
Trials, Cardiovascular Research Foundation, New York, NY, United States
(Serruys) Imperial College London, London, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background: Numerous randomised trials have compared coronary artery
bypass grafting (CABG) with percutaneous coronary intervention (PCI) for
patients with coronary artery disease. However, no studies have been
powered to detect a difference in mortality between the revascularisation
strategies. <br/>Method(s): We did a systematic review up to July 19,
2017, to identify randomised clinical trials comparing CABG with PCI using
stents. Eligible studies included patients with multivessel or left main
coronary artery disease who did not present with acute myocardial
infarction, did PCI with stents (bare-metal or drug-eluting), and had more
than 1 year of follow-up for all-cause mortality. In a collaborative,
pooled analysis of individual patient data from the identified trials, we
estimated all-cause mortality up to 5 years using Kaplan-Meier analyses
and compared PCI with CABG using a random-effects Cox proportional-hazards
model stratified by trial. Consistency of treatment effect was explored in
subgroup analyses, with subgroups defined according to baseline clinical
and anatomical characteristics. <br/>Finding(s): We included 11 randomised
trials involving 11 518 patients selected by heart teams who were assigned
to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean
follow-up of 3.8 years (SD 1.4). Mean Synergy between PCI with Taxus and
Cardiac Surgery (SYNTAX) score was 26.0 (SD 9.5), with 1798 (22.1%) of
8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause
mortality was 11.2% after PCI and 9.2% after CABG (hazard ratio [HR] 1.20,
95% CI 1.06-1.37; p=0.0038). 5 year all-cause mortality was significantly
different between the interventions in patients with multivessel disease
(11.5% after PCI vs 8.9% after CABG; HR 1.28, 95% CI 1.09-1.49; p=0.0019),
including in those with diabetes (15.5% vs 10.0%; 1.48, 1.19-1.84;
p=0.0004), but not in those without diabetes (8.7% vs 8.0%; 1.08,
0.86-1.36; p=0.49). SYNTAX score had a significant effect on the
difference between the interventions in multivessel disease. 5 year
all-cause mortality was similar between the interventions in patients with
left main disease (10.7% after PCI vs 10.5% after CABG; 1.07, 0.87-1.33;
p=0.52), regardless of diabetes status and SYNTAX score.
<br/>Interpretation(s): CABG had a mortality benefit over PCI in patients
with multivessel disease, particularly those with diabetes and higher
coronary complexity. No benefit for CABG over PCI was seen in patients
with left main disease. Longer follow-up is needed to better define
mortality differences between the revascularisation strategies.
<br/>Funding(s): None.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<80>
Accession Number
2001262560
Title
Blinded outcomes and angina assessment of coronary bioresorbable
scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial.
Source
The Lancet. 392 (10157) (pp 1530-1540), 2018. Date of Publication: 27
October - 2 November 2018.
Author
Stone G.W.; Ellis S.G.; Gori T.; Metzger D.C.; Stein B.; Erickson M.;
Torzewski J.; Williams J.; Lawson W.; Broderick T.M.; Kabour A.; Piegari
G.; Cavendish J.; Bertolet B.; Choi J.W.; Marx S.O.; Genereux P.;
Kereiakes D.J.
Institution
(Stone, Marx) NewYork-Presbyterian Hospital/Columbia University Medical
Center, New York, NY, United States
(Stone, Genereux) Clinical Trials Center, Cardiovascular Research
Foundation, New York, NY, United States
(Ellis) Cleveland Clinic, Cleveland, OH, United States
(Gori) Kardiologie I University Medical Center and Deutsches Zentrum fur
Herz-Kreislaufforschung, Rhein-Main, Mainz, Germany
(Metzger) Ballad Health Systems CVA Heart Institute, Kingsport, TN, United
States
(Stein) Morton Plant Hospital, Clearwater, FL, United States
(Erickson) Royal Perth Hospital, Perth, WA, Australia
(Torzewski) Kliniken Oberallgau, Immenstadt, Germany
(Williams) Presbyterian Hospital, Charlotte, NC, United States
(Lawson) Stony Brook University Medical Center, Stony Brook, NY, United
States
(Broderick, Kereiakes) The Carl and Edyth Lindner Research Center at The
Christ Hospital, Cincinnati, OH, United States
(Kabour) Mercy St Vincent Medical Center, Toledo, OH, United States
(Piegari) St Joseph Medical Center, Wyomissing, PA, United States
(Cavendish) Scripps Memorial Hospital La Jolla, La Jolla, CA, United
States
(Bertolet) North Mississippi Medical Center, Tupelo, MS, United States
(Choi) Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas,
TX, United States
(Genereux) Gagnon Cardiovascular Institute, Morristown Medical Center,
Morristown, NJ, United States
(Genereux) Hopital du Sacre-Coeur de Montreal, Montreal, QC, Canada
Publisher
Lancet Publishing Group
Abstract
Background: Previous studies showed more adverse events with coronary
bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting
stents (DES), although in one randomised trial angina was reduced with
BVS. However, these early studies were unmasked, lesions smaller than
intended for the scaffold were frequently enrolled, implantation technique
was suboptimal, and patients with myocardial infarction, in whom BVS might
be well suited, were excluded. <br/>Method(s): In the active-controlled,
blinded, multicentre, randomised ABSORB IV trial, patients with stable
coronary artery disease or acute coronary syndromes aged 18 years or older
were recruited from 147 hospitals in five countries (the USA, Germany,
Australia, Singapore, and Canada). Enrolled patients were randomly
assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott
Vascular, Santa Clara, CA, USA) with optimised implantation technique or
cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular,
Santa Clara, CA, USA). Randomisation was stratified by diabetic status,
whether patients would have been eligible for enrolment in the previous
ABSORB III trial, and site. Patients and clinical assessors were masked to
randomisation. The primary endpoint was target lesion failure (cardiac
death, target vessel myocardial infarction, or ischaemia-driven target
lesion revascularisation) at 30 days, tested for non-inferiority with a
2.9% margin for the risk difference. Analysis was by intention to treat.
The trial is registered with ClinicalTrials.gov, number NCT02173379, and
is closed to accrual. <br/>Finding(s): Between Aug 15, 2014, and March 31,
2017, we screened 18 722 patients for eligibility, 2604 of whom were
enrolled. 1296 patients were assigned to BVS, and 1308 patients were
assigned to EES. Follow-up data at 30 days and 1 year, respectively, were
available for 1288 and 1254 patients with BVS and for 1303 and 1272
patients with EES. Biomarker-positive acute coronary syndromes were
present in 622 (24%) of 2602 patients, and, by angiographic core
laboratory analysis, 78 (3%) of 2893 of lesions were in very small
vessels. Target lesion failure at 30 days occurred in 64 (5.0%) patients
assigned to BVS and 48 (3.7%) patients assigned to EES (difference 1.3%,
upper 97.5% confidence limit 2.89; one-sided
p<inf>non-inferiority</inf>=0.0244). Target lesion failure at 1 year
occurred in 98 (7.8%) patients assigned to BVS and 82 (6.4%) patients
assigned to EES (difference 1.4%, upper 97.5% confidence limit 3.4;
one-sided p<inf>non-inferiority</inf>=0.0006). Angina, adjudicated by a
central events committee at 1 year, occurred in 270 (20.3%) patients
assigned to BVS and 274 (20.5%) patients assigned to EES (difference
-0.3%, 95% CI -3.4% to 2.9%; one-sided p<inf>non-inferiority</inf>=0.0008;
two-sided p<inf>superiority</inf>=0.8603). Device thrombosis within 1 year
occurred in nine (0.7%) patients assigned to BVS and four (0.3%) patients
assigned to EES (p=0.1586). <br/>Interpretation(s): Polymeric BVS
implanted with optimised technique in an expanded patient population
resulted in non-inferior 30-day and 1-year rates of target lesion failure
and angina compared with metallic DES. <br/>Funding(s): Abbott
Vascular.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<81>
Accession Number
2001206526
Title
Baseline and on-statin treatment lipoprotein(a) levels for prediction of
cardiovascular events: individual patient-data meta-analysis of statin
outcome trials.
Source
The Lancet. 392 (10155) (pp 1311-1320), 2018. Date of Publication: 13 - 19
October 2018.
Author
Willeit P.; Ridker P.M.; Nestel P.J.; Simes J.; Tonkin A.M.; Pedersen
T.R.; Schwartz G.G.; Olsson A.G.; Colhoun H.M.; Kronenberg F.; Drechsler
C.; Wanner C.; Mora S.; Lesogor A.; Tsimikas S.
Institution
(Willeit) Department of Neurology, Medical University of Innsbruck,
Innsbruck, Austria
(Willeit) Department of Public Health and Primary Care, University of
Cambridge, Cambridge, United Kingdom
(Ridker, Mora) Brigham and Women's Hospital, Harvard Medical School,
Boston, MA, United States
(Nestel) Baker Heart and Diabetes Institute, Melbourne, Vic, Australia
(Simes) NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW,
Australia
(Tonkin) Department of Epidemiology and Preventive Medicine, Monash
University, Melbourne, Vic, Australia
(Pedersen) Oslo University Hospital, Ulleval, and Medical Faculty,
University of Oslo, Oslo, Norway
(Schwartz) Division of Cardiology, VA Medical Center and University of
Colorado School of Medicine, Denver, CO, United States
(Olsson) Department of Medicine and Care, Faculty of Health Sciences,
University of Linkoping, Linkoping, Sweden
(Colhoun) MRC Human Genetics Unit, Centre for Genomic and Experimental
Medicine, MRC Institute of Genetics & Molecular Medicine, Edinburgh,
United Kingdom
(Kronenberg) Division of Genetic Epidemiology, Department of Medical
Genetics, Molecular and Clinical Pharmacology, Medical University of
Innsbruck, Innsbruck, Austria
(Drechsler, Wanner) Division of Nephrology, Department of Internal
Medicine 1 and Comprehensive Heart Failure Centre, University Hospital of
Wurzburg, Wurzburg, Germany
(Lesogor) Novartis Pharma AG, Basel, Switzerland
(Tsimikas) Vascular Medicine Program, Sulpizio Cardiovascular Center,
Division of Cardiology, Department of Medicine, University of California
San Diego, La Jolla, CA, United States
(Tsimikas) Vascular Medicine Program, Sulpizio Cardiovascular Center,
University of California San Diego, La Jolla, CA 92093, United States
Publisher
Lancet Publishing Group
Abstract
Background: Elevated lipoprotein(a) is a genetic risk factor for
cardiovascular disease in general population studies. However, its
contribution to risk for cardiovascular events in patients with
established cardiovascular disease or on statin therapy is uncertain.
<br/>Method(s): Patient-level data from seven randomised,
placebo-controlled, statin outcomes trials were collated and harmonised to
calculate hazard ratios (HRs) for cardiovascular events, defined as fatal
or non-fatal coronary heart disease, stroke, or revascularisation
procedures. HRs for cardiovascular events were estimated within each trial
across predefined lipoprotein(a) groups (15 to <30 mg/dL, 30 to <50 mg/dL,
and >=50 mg/dL, vs <15 mg/dL), before pooling estimates using multivariate
random-effects meta-analysis. <br/>Finding(s): Analyses included data for
29 069 patients with repeat lipoprotein(a) measurements (mean age 62 years
[SD 8]; 8064 [28%] women; 5751 events during 95 576 person-years at risk).
Initiation of statin therapy reduced LDL cholesterol (mean change -39%
[95% CI -43 to -35]) without a significant change in lipoprotein(a).
Associations of baseline and on-statin treatment lipoprotein(a) with
cardiovascular disease risk were approximately linear, with increased risk
at lipoprotein(a) values of 30 mg/dL or greater for baseline
lipoprotein(a) and 50 mg/dL or greater for on-statin lipoprotein(a). For
baseline lipoprotein(a), HRs adjusted for age and sex (vs <15 mg/dL) were
1.04 (95% CI 0.91-1.18) for 15 mg/dL to less than 30 mg/dL, 1.11
(1.00-1.22) for 30 mg/dL to less than 50 mg/dL, and 1.31 (1.08-1.58) for
50 mg/dL or higher; respective HRs for on-statin lipoprotein(a) were 0.94
(0.81-1.10), 1.06 (0.94-1.21), and 1.43 (1.15-1.76). HRs were almost
identical after further adjustment for previous cardiovascular disease,
diabetes, smoking, systolic blood pressure, LDL cholesterol, and HDL
cholesterol. The association of on-statin lipoprotein(a) with
cardiovascular disease risk was stronger than for on-placebo
lipoprotein(a) (interaction p=0.010) and was more pronounced at younger
ages (interaction p=0.008) without effect-modification by any other
patient-level or study-level characteristics. <br/>Interpretation(s): In
this individual-patient data meta-analysis of statin-treated patients,
elevated baseline and on-statin lipoprotein(a) showed an independent
approximately linear relation with cardiovascular disease risk. This study
provides a rationale for testing the lipoprotein(a) lowering hypothesis in
cardiovascular disease outcomes trials. <br/>Funding(s): Novartis Pharma
AG.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<82>
Accession Number
2001193010
Title
Targeted therapy with a localised abluminal groove, low-dose
sirolimus-eluting, biodegradable polymer coronary stent (TARGET All
Comers): a multicentre, open-label, randomised non-inferiority trial.
Source
The Lancet. 392 (10153) (pp 1117-1126), 2018. Date of Publication: 29
September - 5 October 2018.
Author
Lansky A.; Wijns W.; Xu B.; Kelbaek H.; van Royen N.; Zheng M.; Morel
M.-A.; Knaapen P.; Slagboom T.; Johnson T.W.; Vlachojannis G.; Arkenbout
K.E.; Holmvang L.; Janssens L.; Ochala A.; Brugaletta S.; Naber C.K.;
Anderson R.; Rittger H.; Berti S.; Barbato E.; Toth G.G.; Maillard L.;
Valina C.; Buszman P.; Thiele H.; Schachinger V.; Baumbach A.
Institution
(Lansky, Baumbach) Yale University School of Medicine, New Haven, CT,
United States
(Lansky, Baumbach) Barts Heart Centre, London and Queen Mary University of
London, London, United Kingdom
(Wijns) The Lambe Institute for Translational Medicine and Curam, National
University of Ireland, Galway and Saolta University Healthcare Group,
University College Hospital Galway, Galway, Ireland
(Xu) Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese
Academy of Medical Sciences, Beijing, China
(Kelbaek) Department of Cardiology, Roskilde University Hospital,
Roskilde, Denmark
(van Royen, Knaapen) Department of Cardiology, VU University Medical
Centre, Amsterdam, Netherlands
(Zheng) Shanghai MicroPort Medical (Group), Shanghai, China
(Morel) Cardialysis, Rotterdam, Netherlands
(Slagboom) Amsterdam Department of Interventional Cardiolody, Onze Lieve
Vrouwe Gasthuis, Amsterdam, Netherlands
(Johnson) Bristol Heart Institute, University Hospitals Bristol NHS
Foundation Trust, Bristol, United Kingdom
(Vlachojannis) Department of Cardiology, Maasstad Ziekenhuis, Rotterdam,
Netherlands
(Arkenbout) Department of Cardiology, Tergooi Ziekenhuis, Blaricum,
Netherlands
(Holmvang) Department of Cardiology, Rigshospitalet, Copenhagen University
Hospital, Copenhagen, Denmark
(Janssens) Heart Centre, Imelda Ziekenhuis, Bonheiden, Belgium
(Ochala) Department of Invasive Cardiology, Silesian Medical University,
Katowice, Poland
(Brugaletta) Cardiovascular Institute, Hospital Clinic, Institut
d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona,
Spain
(Naber) Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen,
Germany
(Anderson) Department of Cardiology, University Hospital of Wales,
Cardiff, United Kingdom
(Rittger) Medizinische Klinik I, Klinikum Furth, University of Erlangen,
Furth, Germany
(Berti) UOC Cardiologia Diagnostica ed Interventistica, Fondazione CNR Reg
Toscana G Monasterio, Ospedale del Cuore, Massa, Italy
(Barbato) Cardiovascular Research Centre Aalst, OLV Hospital, Aalst,
Belgium
(Barbato) Department of Advanced Biomedical Sciences, University of Naples
Federico II, Italy
(Toth) Department of Cardiology, Medical University of Graz, Graz, Austria
(Maillard) Service de Cardiologie, Clinique Axium, Aix-en-Provence, France
(Valina) Klinik fur Kardiologie und Angiologie II,
Universitats-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
(Buszman) American Heart of Poland, Katowice, Poland
(Thiele) Herzzentrum Leipzig, Leipzig, Germany
(Schachinger) Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda,
Fulda, Germany
Publisher
Lancet Publishing Group
Abstract
Background: The FIREHAWK is a drug-eluting stent with a fully
biodegradable sirolimus-containing polymer coating localised to recessed
abluminal grooves on the stent surface. We investigated clinical outcomes
with this targeted, low-dose, biodegradable polymer, sirolimus-eluting
stent compared with XIENCE durable polymer, everolimus-eluting stents in
an all-comers population. <br/>Method(s): The TARGET All Comers study was
a prospective, multicentre, open-label randomised non-inferiority trial
done at 21 centres in ten European countries. Patients with symptomatic or
asymptomatic coronary artery disease and objective evidence of myocardial
ischaemia who qualified for percutaneous coronary intervention were
randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE.
Randomisation was web-based, with random block allocation and
stratification by centre and ST elevation myocardial infarction. Outcome
assessors were masked to treatment allocation, but treating physicians and
patients were not. The primary endpoint was target lesion failure at 12
months, a composite of cardiac death, target vessel myocardial infarction,
or ischaemia-driven target lesion revascularisation. The control event
rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%,
and the primary analysis was in the intention-to-treat population,
censoring patients who did not have either an event before 365 days or
contact beyond 365 days. Late lumen loss was the primary endpoint of an
angiographic substudy designed to investigate the non-inferiority of the
FIREHAWK compared with the XIENCE stent. This trial is registered with
ClinicalTrials.gov, number NCT02520180. <br/>Finding(s): From Dec 17,
2015, to Oct 14, 2016, 1653 patients were randomly assigned to
implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the
FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data
and were excluded from the analyses. At 12 months, target lesion failure
occurred in 46 (6.1%) of 758 patients in the FIREHAWK group and in 45
(5.9%) of 764 patients in the XIENCE group (difference 0.2%, 90% CI -1.9
to 2.2, p<inf>non-inferiority</inf>=0.004, 95% CI -2.2 to 2.6,
p<inf>superiority</inf>=0.88). There were no differences in
ischaemia-driven revascularisation or stent thrombosis rates at 12 months.
176 patients were included in the angiographic substudy, in which in-stent
late lumen loss was 0.17 mm (SD 0.48) in the FIREHAWK group and 0.11 mm
(0.52) in the XIENCE group (p=0.48), with an absolute difference of 0.05
mm (95% CI -0.09 to 0.18, p<inf>non-inferiority</inf>=0.024).
<br/>Interpretation(s): In a broad all-comers population of patients
requiring stent implantation for myocardial ischaemia, the FIREHAWK was
non-inferior to the XIENCE as assessed with the primary endpoint of target
lesion failure at 12 months and in-stent late lumen loss at 13 months. The
FIREHAWK is a safe and effective alternative stent to treat patients with
ischaemic coronary artery disease in clinical practice. <br/>Funding(s):
Shanghai Microport Medical.<br/>Copyright &#xa9; 2018 Elsevier Ltd

<83>
Accession Number
619362219
Title
Relationship of C-reactive protein reduction to cardiovascular event
reduction following treatment with canakinumab: a secondary analysis from
the CANTOS randomised controlled trial.
Source
The Lancet. 391 (10118) (pp 319-328), 2018. Date of Publication: 27 Jan
2018.
Author
Ridker P.M.; MacFadyen J.G.; Everett B.M.; Libby P.; Thuren T.; Glynn
R.J.; Kastelein J.; Koenig W.; Genest J.; Lorenzatti A.; Varigos J.;
Siostrzonek P.; Sinnaeve P.; Fonseca F.; Nicolau J.; Gotcheva N.; Yong H.;
Urina-Triana M.; Milicic D.; Cifkova R.; Vettus R.; Anker S.D.; Manolis
A.J.; Wyss F.; Forster T.; Sigurdsson A.; Pais P.; Fucili A.; Ogawa H.;
Shimokawa H.; Veze I.; Petrauskiene B.; Salvador L.; Cornel J.H.; Klemsdal
T.O.; Medina F.; Budaj A.; Vida-Simiti L.; Kobalava Z.; Otasevic P.; Pella
D.; Lainscak M.; Seung K.-B.; Commerford P.; Dellborg M.; Donath M.; Hwang
J.-J.; Kultursay H.; Flather M.; Ballantyne C.; Bilazarian S.; Chang W.;
East C.; Forgosh L.; Harris B.; Ligueros M.
Institution
(Ridker, MacFadyen, Everett, Glynn) Center for Cardiovascular Disease
Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston,
MA, United States
(Ridker, Everett, Libby) Cardiovascular Division, Brigham and Women's
Hospital, Harvard Medical School, Boston, MA, United States
(Thuren) Novartis Pharmaceutical Corporation, East Hanover, NJ, United
States
(Thuren) Novartis Pharmaceutical Corporation, Basel, Switzerland
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: Canakinumab, a monoclonal antibody targeting interleukin-1beta
reduces inflammation and cardiovascular event rates with no effect on
lipid concentrations. However, it is uncertain which patient groups
benefit the most from treatment and whether reductions in the inflammatory
biomarker high-sensitivity C-reactive protein (hsCRP) correlate with
clinical benefits for individual patients. <br/>Method(s): The Canakinumab
Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) used
computer-generated codes to randomly allocate 10 061 men and women with a
history of myocardial infarction to placebo or one of three doses of
canakinumab (50 mg, 150 mg, or 300 mg) given subcutaneously once every 3
months. In a prespecified secondary analysis designed to address the
relationship of hsCRP reduction to event reduction in CANTOS, we evaluated
the effects of canakinumab on rates of major adverse cardiovascular
events, cardiovascular mortality, and all-cause mortality according to
on-treatment concentrations of hsCRP. We used multivariable modelling to
adjust for baseline factors associated with achieved hsCRP and multiple
sensitivity analyses to address the magnitude of residual confounding. The
median follow-up was 3.7 years. The trial is registered with
ClinicalTrials.gov, number NCT01327846. <br/>Finding(s): Baseline clinical
characteristics did not define patient groups with greater or lesser
cardiovascular benefits when treated with canakinumab. However, trial
participants allocated to canakinumab who achieved hsCRP concentrations
less than 2 mg/L had a 25% reduction in major adverse cardiovascular
events (multivariable adjusted hazard ratio [HR^adj]=0.75, 95%
CI 0.66-0.85, p<0.0001), whereas no significant benefit was observed among
those with on-treatment hsCRP concentrations of 2 mg/L or above
(HR^adj=0.90, 0.79-1.02, p=0.11). For those treated with
canakinumab who achieved on-treatment hsCRP concentrations less than 2
mg/L, cardiovascular mortality (HR^adj=0.69, 95% CI 0.56-0.85,
p=0.0004) and all-cause mortality (HR^adj=0.69, 0.58-0.81,
p<0.0001) were both reduced by 31%, whereas no significant reduction in
these endpoints was observed among those treated with canakinumab who
achieved hsCRP concentrations of 2 mg/L or above. Similar differential
effects were found in analyses of the trial prespecified secondary
cardiovascular endpoint (which additionally included hospitalisation for
unstable angina requiring unplanned revascularisation) and in sensitivity
analyses alternatively based on median reductions in hsCRP, on 50% or
greater reductions in hsCRP, on the median percent reduction in hsCRP, in
dose-specific analyses, and in analyses using a causal inference approach
to estimate the effect of treatment among individuals who would achieve a
targeted hsCRP concentration. <br/>Interpretation(s): The magnitude of
hsCRP reduction following a single dose of canakinumab might provide a
simple clinical method to identify individuals most likely to accrue the
largest benefit from continued treatment. These data further suggest that
lower is better for inflammation reduction with canakinumab.
<br/>Funding(s): Novartis Pharmaceuticals.<br/>Copyright &#xa9; 2018
Elsevier Ltd

<84>
Accession Number
617421439
Title
2-year outcomes with the Absorb bioresorbable scaffold for treatment of
coronary artery disease: a systematic review and meta-analysis of seven
randomised trials with an individual patient data substudy.
Source
The Lancet. 390 (10096) (pp 760-772), 2017. Date of Publication: 19 - 25
August 2017.
Author
Ali Z.A.; Serruys P.W.; Kimura T.; Gao R.; Ellis S.G.; Kereiakes D.J.;
Onuma Y.; Simonton C.; Zhang Z.; Stone G.W.
Institution
(Ali, Stone) New York Presbyterian Hospital, Columbia University Medical
Center and the Cardiovascular Research Foundation, New York, NY, United
States
(Serruys) International Centre for Cardiovascular Health, Imperial
College, London, London, United Kingdom
(Kimura) Kyoto University Hospital, Kyoto, Japan
(Gao) Fu Wai Hospital, National Center for Cardiovascular Diseases,
Chinese Academy of Medical Sciences, Beijing, China
(Ellis) Cleveland Clinic, Cleveland, OH, United States
(Kereiakes) The Christ Hospital, Heart and Vascular Center, Lindner
Research Center, Cincinnati, OH, United States
(Onuma) Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
(Simonton, Zhang) Abbott Vascular, Santa Clara, CA, United States
Publisher
Lancet Publishing Group
Abstract
Background Bioresorbable vascular scaffolds (BVS) offer the potential to
improve long-term outcomes of percutaneous coronary intervention after
their complete bioresorption. Randomised trials have shown non-inferiority
between BVS and metallic drug-eluting stents at 1 year in composite safety
and effectiveness outcomes, although some increases in rates of target
vessel-related myocardial infarction and device thrombosis were
identified. Outcomes of BVS following the first year after implantation
are unknown. We sought to ascertain whether BVS are as safe and effective
as drug-eluting stents within 2 years after implantation and between 1 and
2 years. Methods We did a systematic review and meta-analysis of
randomised trials in which patients were randomly assigned to
everolimus-eluting Absorb BVS or metallic everolimus-eluting stents (EES)
and followed up for at least 2 years. We searched MEDLINE, the Cochrane
database, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource,
and abstracts and presentations from major cardiovascular meetings up to
April 1, 2017, to identify relevant studies. The primary efficacy outcome
measure was the device-oriented composite endpoint (cardiac mortality,
target vessel-related myocardial infarction, or ischaemia-driven target
lesion revascularisation) and the primary safety outcome measure was
definite or probable device thrombosis. Individual patient data from the
four ABSORB trials were used for landmark and subgroup analysis and
multivariable modelling. Findings We identified seven randomised trials in
which 5583 patients were randomly assigned to Absorb BVS (n=3261) or
metallic EES (n=2322) and followed up for 2 years. BVS had higher 2-year
relative risks of the device-oriented composite endpoint than did EES
(9.4% [304 of 3217] vs 7.4% [169 of 2299]; relative risk [RR] 1.29 [95% CI
1.08-1.56], p=0.0059). These differences were driven by increased rates of
target vessel-related myocardial infarction (5.8% [187 of 3218] vs 3.2%
[74 of 2299]; RR 1.68 [95% CI 1.29-2.19], p=0.0003) and ischaemia-driven
target lesion revascularisation (5.3% [169 of 3217] vs 3.9% [90 of 2300];
1.40 [1.09-1.80], p=0.0090) with BVS, with non-significant differences in
cardiac mortality. The cumulative 2-year incidence of device thrombosis
was higher with BVS than with EES (2.3% [73 of 3187] vs 0.7% [16 of 2281];
RR 3.35 [95% CI 1.96-5.72], p<0.0001). Landmark analysis between 1 and 2
years also showed higher rates of the device-oriented composite endpoint
(3.3% [69 of 2100] vs 1.9% [23 of 1193]; RR 1.64 [95% CI 1.03-2.61],
p=0.0376) and device thrombosis (0.5% [11 of 2085] vs none [0 of 1183],
p<0.0001) in BVS-treated patients than in EES-treated patients.
Interpretation BVS was associated with increased rates of composite
device-oriented adverse events and device thrombosis cumulatively at 2
years and between 1 and 2 years of follow-up compared with EES. Funding
Abbott Vascular.<br/>Copyright &#xa9; 2017 Elsevier Ltd

<85>
Accession Number
616541696
Title
Intraoperative ketamine for prevention of postoperative delirium or pain
after major surgery in older adults: an international, multicentre,
double-blind, randomised clinical trial.
Source
The Lancet. 390 (10091) (pp 267-275), 2017. Date of Publication: 15 Jul
2017.
Author
Avidan M.S.; Maybrier H.R.; Abdallah A.B.; Jacobsohn E.; Vlisides P.E.;
Pryor K.O.; Veselis R.A.; Grocott H.P.; Emmert D.A.; Rogers E.M.; Downey
R.J.; Yulico H.; Noh G.-J.; Lee Y.H.; Waszynski C.M.; Arya V.K.; Pagel
P.S.; Hudetz J.A.; Muench M.R.; Fritz B.A.; Waberski W.; Inouye S.K.;
Mashour G.A.; Apakama G.P.; Aquino K.G.; Dicks R.S.; Escallier K.E.;
Fardous H.; Funk D.J.; Gipson K.E.; Girardi L.N.; Gruber A.T.; Ivascu
N.S.; Jayant A.; Kashani H.H.; Kavosh M.S.; Kunkler B.S.; Lenze E.J.;
McKinney A.S.; McKinnon S.L.; Mickle A.M.; Monterola M.; Murphy M.R.;
Redko M.; Schmitt E.M.; Sivanesan L.; Steinkamp M.L.; Tellor B.; Thomas
S.; Upadhyayula R.T.
Institution
(Avidan, Maybrier, Abdallah, Emmert, Muench, Fritz) Department of
Anesthesiology, Washington University School of Medicine, Saint Louis, MO,
United States
(Jacobsohn) Department of Anesthesiology and Department of Internal
Medicine, University of Manitoba, Winnipeg, MB, Canada
(Grocott) Department of Anesthesia and Perioperative Medicine, University
of Manitoba, Winnipeg, MB, Canada
(Vlisides, Mashour) Department of Anesthesiology, University of Michigan,
Ann Arbor, MI, United States
(Pryor, Rogers) Department of Anesthesiology, Weill Cornell Medicine, New
York City, NY, United States
(Veselis) Department of Neuroanesthesiology, Memorial Sloan Kettering
Cancer Center, New York City, NY, United States
(Downey) Department of Surgery, Memorial Sloan Kettering Cancer Center,
New York City, NY, United States
(Yulico) Department of Anesthesiology, Memorial Sloan Kettering Cancer
Center, New York City, NY, United States
(Noh, Lee) Department of Anesthesiology, Asan Medical Center, Seoul, South
Korea
(Waszynski) Department of Medicine, Hartford Hospital, Hartford, CT,
United States
(Arya) Department of Anaesthesiology and Intensive Care, Postgraduate
Institute of Medical Education and Research, Chandigarh, India
(Pagel, Hudetz) Department of Anesthesiology, Medical College of
Wisconsin, Milwaukee, WI, United States
(Waberski) Department of Anesthesiology, Hartford Hospital, Hartford,
Connecticut, United States
(Inouye) Department of Medicine, Beth Israel Deaconess Medical Center,
Harvard Medical School, Institute for Aging Research, Hebrew SeniorLife,
Boston, MA, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Delirium is a common and serious postoperative complication.
Subanaesthetic ketamine is often administered intraoperatively for
postoperative analgesia, and some evidence suggests that ketamine prevents
delirium. The primary purpose of this trial was to assess the
effectiveness of ketamine for prevention of postoperative delirium in
older adults. Methods The Prevention of Delirium and Complications
Associated with Surgical Treatments [PODCAST] study is a multicentre,
international randomised trial that enrolled adults older than 60 years
undergoing major cardiac and non-cardiac surgery under general
anaesthesia. Using a computer-generated randomisation sequence we randomly
assigned patients to one of three groups in blocks of 15 to receive
placebo (normal saline), low-dose ketamine (0.5 mg/kg), or high dose
ketamine (1.0 mg/kg) after induction of anaesthesia, before surgical
incision. Participants, clinicians, and investigators were blinded to
group assignment. Delirium was assessed twice daily in the first 3
postoperative days using the Confusion Assessment Method. We did analyses
by intention-to-treat and assessed adverse events. This trial is
registered with clinicaltrials.gov, number NCT01690988. Findings Between
Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were
randomly assigned, with 222 in the placebo group, 227 in the 0.5 mg/kg
ketamine group, and 223 in the 1.0 mg/kg ketamine group. There was no
difference in delirium incidence between patients in the combined ketamine
groups and the placebo group (19.45% vs 19.82%, respectively; absolute
difference 0.36%, 95% CI -6.07 to 7.38, p=0.92). There were more
postoperative hallucinations (p=0.01) and nightmares (p=0.03) with
increasing ketamine doses compared with placebo. Adverse events
(cardiovascular, renal, infectious, gastrointestinal, and bleeding),
whether viewed individually (p value for each >0.40) or collectively
(36.9% in placebo, 39.6% in 0.5 mg/kg ketamine, and 40.8% in 1.0 mg/kg
ketamine groups, p=0.69), did not differ significantly across groups.
Interpretation A single subanaesthetic dose of ketamine did not decrease
delirium in older adults after major surgery, and might cause harm by
inducing negative experiences. Funding National Institutes of Health and
Cancer Center Support.<br/>Copyright &#xa9; 2017 Elsevier Ltd

<86>
Accession Number
618044514
Title
Population screening and intervention for vascular disease in Danish men
(VIVA): a randomised controlled trial.
Source
The Lancet. 390 (10109) (pp 2256-2265), 2017. Date of Publication: 18 - 24
November 2017.
Author
Lindholt J.S.; Sogaard R.
Institution
(Lindholt) Department of Cardiothoracic and Vascular Surgery, Odense
University Hospital, Odense, Denmark
(Lindholt) Vascular Research Unit, Viborg Hospital, Viborg, Denmark
(Sogaard) Department of Public Health and Department of Clinical Medicine,
Aarhus University, Aarhus, Denmark
Publisher
Lancet Publishing Group
Abstract
Background Abdominal aortic aneurysm is the only cardiovascular disease
targeted by population screening. In this study, we test the effect of
screening and subsequent intervention for abdominal aortic aneurysm,
peripheral arterial disease, and hypertension combined. Methods In this
randomised controlled trial, we randomly allocated (1:1) all men aged
65-74 years living in the Central Denmark Region to screening for
abdominal aortic aneurysm, peripheral arterial disease, and hypertension,
or to no screening. We based allocation on computer-generated random
numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19
municipalities. Only the non-screening group and the investigator
assessing outcomes were masked. We invited participants who were found to
have abdominal aortic aneurysm or peripheral arterial disease back for
confirmation and eventual initiation of relevant pharmacological therapy.
We further offered participants with abdominal aortic aneurysm annual
control or surgical repair. We referred participants with suspected
hypertension to their general practitioner. The primary outcome was
all-cause mortality, assessed 5 years after randomisation, analysed in all
randomly allocated participants except for those who had incorrect person
identification numbers. This trial is registered at ClinicalTrials.gov,
number NCT00662480. Findings Between Oct 8, 2008, and Jan 11, 2011, we
randomly allocated 50 156 participants, with 25 078 (50%) each in the
screening and non-screening groups. Four (<1%) participants in the
screening group were lost to follow-up. After a median follow-up of 4.4
years (IQR 3.9-4.8), 2566 (10.2%) of 25 074 participants in the screening
group and 2715 (10.8%) of 25 078 in the non-screening group had died. This
finding resulted in a significant hazard ratio of 0.93 (95% CI 0.88-0.98;
p=0.01), an absolute risk reduction of 0.006 (0.001-0.011), and a number
needed to invite of 169 (89-1811). Incidences of diabetes (3995 per 100
000 person-years in the screening group vs 4129 per 100 000 person-years
in the non-screening group), intracerebral haemorrhage (146 vs 140), renal
failure (612 vs 649), cancer (3578 vs 3719), or 30 day mortality after
cardiovascular surgery (44.57 vs 39.33) did not differ between groups.
Interpretation The observed reduction of mortality risk from abdominal
aortic aneurysm, peripheral arterial disease, and hypertension has never
been seen before in the population screening literature and can be linked
primarily to initiation of pharmacological therapy. Health policy makers
should consider implementing combined screening whether no screening or
isolated abdominal aortic aneurysm screening is currently offered. Funding
The 7th European Framework Programme, Central Denmark Region, Viborg
Hospital, and the Danish Council for Independent Research.<br/>Copyright
&#xa9; 2017 Elsevier Ltd

<87>
Accession Number
618044503
Title
Clinical efficacy and safety of achieving very low LDL-cholesterol
concentrations with the PCSK9 inhibitor evolocumab: a prespecified
secondary analysis of the FOURIER trial.
Source
The Lancet. 390 (10106) (pp 1962-1971), 2017. Date of Publication: 28
October - 3 November 2017.
Author
Giugliano R.P.; Pedersen T.R.; Park J.-G.; De Ferrari G.M.; Gaciong Z.A.;
Ceska R.; Toth K.; Gouni-Berthold I.; Lopez-Miranda J.; Schiele F.; Mach
F.; Ott B.R.; Kanevsky E.; Pineda A.L.; Somaratne R.; Wasserman S.M.;
Keech A.C.; Sever P.S.; Sabatine M.S.
Institution
(Giugliano, Park, Kanevsky, Sabatine) TIMI Study Group, Division of
Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, United
States
(Pedersen) Oslo University Hospital, Ulleval and Medical Faculty,
University of Oslo, Oslo, Norway
(De Ferrari) Department of Molecular Medicine, University of Pavia and
Cardiac Intensive Care Unit and Laboratories for Experimental Cardiology,
IRCCS Fondazione Policlinico San Matteo, Pavia, Italy
(Gaciong) Department of Internal Medicine, Hypertension and Vascular
Diseases, The Medical University of Warsaw, Warsaw, Poland
(Ceska) Center of Preventive Cardiology, 3rd Department Internal Medicine,
University General Hospital and 1st Medical Faculty, Prague, Czechia
(Toth) 1st Department of Medicine, University of Pecs, Pecs, Hungary
(Gouni-Berthold) Polyclinic for Endocrinology, Diabetes, and Preventive
Medicine, University of Cologne, Cologne, Germany
(Lopez-Miranda) Lipids and Atherosclerosis Unit, Maimonides Biomedical
Research Institute of Cordoba, Reina Sofia University Hospital, University
of Cordoba, CIBEROBN, Cordoba, Spain
(Schiele) University Hospital Center Besancon, Besancon, France
(Mach) Hopital Cantonal, Hopitaux Universitaires de Geneva, Geneva,
Switzerland
(Ott) Rhode Island Hospital, Department of Neurology, Alpert Medical
School of Brown University, Providence, RI, United States
(Pineda, Somaratne, Wasserman) Amgen, Thousand Oaks, CA, United States
(Keech) Sydney Medical School, National Health and Medical Research
Council Clinical Trials Centre, University of Sydney, Sydney, NSW,
Australia
(Sever) International Centre for Circulatory Health, National Heart and
Lung Institute, Imperial College London, London, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background: LDL cholesterol is a well established risk factor for
atherosclerotic cardiovascular disease. How much one should or safely can
lower this risk factor remains debated. We aimed to explore the
relationship between progressively lower LDL-cholesterol concentrations
achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial
of evolocumab, a monoclonal antibody to proprotein convertase
subtilisin-kexin type 9 (PCSK9). <br/>Method(s): In this prespecified
secondary analysis of 25 982 patients from the randomised FOURIER trial,
the relationship between achieved LDL-cholesterol concentration at 4 weeks
and subsequent cardiovascular outcomes (primary endpoint was the composite
of cardiovascular death, myocardial infarction, stroke, coronary
revascularisation, or unstable angina; key secondary endpoint was the
composite of cardiovascular death, myocardial infarction, or stroke) and
ten prespecified safety events of interest was examined over a median of
2.2 years of follow-up. We used multivariable modelling to adjust for
baseline factors associated with achieved LDL cholesterol. This trial is
registered with ClinicalTrials.gov, number NCT01764633. <br/>Finding(s):
Between Feb 8, 2013, and June 5, 2015, 27 564 patients were randomly
assigned a treatment in the FOURIER study. 1025 (4%) patients did not have
an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a
primary endpoint event or one of the ten prespecified safety events before
the week-4 visit. From the remaining 25 982 patients (94% of those
randomly assigned) 13 013 were assigned evolocumab and 12 969 were
assigned placebo. 2669 (10%) of 25 982 patients achieved LDL-cholesterol
concentrations of less than 0.5 mmol/L, 8003 (31%) patients achieved
concentrations between 0.5 and less than 1.3 mmol/L, 3444 (13%) patients
achieved concentrations between 1.3 and less than 1.8 mmol/L, 7471 (29%)
patients achieved concentrations between 1.8 to less than 2.6 mmol/L, and
4395 (17%) patients achieved concentrations of 2.6 mmol/L or higher. There
was a highly significant monotonic relationship between low
LDL-cholesterol concentrations and lower risk of the primary and secondary
efficacy composite endpoints extending to the bottom first percentile
(LDL-cholesterol concentrations of less than 0.2 mmol/L; p=0.0012 for the
primary endpoint, p=0.0001 for the secondary endpoint). Conversely, no
significant association was observed between achieved LDL cholesterol and
safety outcomes, either for all serious adverse events or any of the other
nine prespecified safety events. <br/>Interpretation(s): There was a
monotonic relationship between achieved LDL cholesterol and major
cardiovascular outcomes down to LDL-cholesterol concentrations of less
than 0.2 mmol/L. Conversely, there were no safety concerns with very low
LDL-cholesterol concentrations over a median of 2.2 years. These data
support further LDL-cholesterol lowering in patients with cardiovascular
disease to well below current recommendations. <br/>Funding(s):
Amgen.<br/>Copyright &#xa9; 2017 Elsevier Ltd

<88>
Accession Number
618030176
Title
Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin,
durable polymer everolimus-eluting stents in patients undergoing coronary
revascularisation (BIOFLOW V): a randomised trial.
Source
The Lancet. 390 (10105) (pp 1843-1852), 2017. Date of Publication: 21 - 27
October 2017.
Author
Kandzari D.E.; Mauri L.; Koolen J.J.; Massaro J.M.; Doros G.;
Garcia-Garcia H.M.; Bennett J.; Roguin A.; Gharib E.G.; Cutlip D.E.;
Waksman R.
Institution
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Mauri) Divison of Cardiovascular Medicine, Brigham and Women's Hospital,
Boston, MA, United States
(Koolen) Catharina Hospital, Eindhoven, Netherlands
(Massaro, Doros) Department of Biostatistics and Epidemiology, Boston
University School of Public Health, Boston, MA, United States
(Doros) Baim Institute for Clinical Research, Boston, MA, United States
(Garcia-Garcia, Waksman) Division of Interventional Cardiology, MedStar
Cardiovascular Research Network, MedStar Washington Hospital Center,
Washington, DC, United States
(Bennett) Department of Cardiovascular Medicine, University Hospitals
Leuven, Leuven, Belgium
(Roguin) Department of Cardiology, Rambam Medical Center, Haifa, Israel
(Gharib) Charleston Area Medical Center, Charleston, WV, United States
(Cutlip) Beth Israel Deaconess Medical Center, Baim Institute for Clinical
Research, Boston, MA, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background The development of coronary drug-eluting stents has included
use of new metal alloys, changes in stent architecture, and use of
bioresorbable polymers. Whether these advancements improve clinical safety
and efficacy has not been shown in previous randomised trials. We aimed to
examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting
stent compared with a durable polymer everolimus-eluting stent in a broad
patient population undergoing percutaneous coronary intervention. Methods
BIOFLOW V was an international, randomised trial done in patients
undergoing elective and urgent percutaneous coronary intervention in 90
hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany,
Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain,
Switzerland, and the USA). Eligible patients were those aged 18 years or
older with ischaemic heart disease undergoing planned stent implantation
in de-novo, native coronary lesions. Patients were randomly assigned (2:1)
to either an ultrathin strut (60 mum) bioresorbable polymer
sirolimus-eluting stent or to a durable polymer everolimus-eluting stent.
Randomisation was via a central web-based data capture system (mixed
blocks of 3 and 6), and stratified by study site. The primary endpoint was
12-month target lesion failure. The primary non-inferiority comparison
combined these data from two additional randomised trials of bioresorbable
polymer sirolimus-eluting stent and durable polymer everolimus-eluting
stent with Bayesian methods. Analysis was by intention to treat. The trial
is registered with ClinicalTrials.gov, number NCT02389946. Findings
Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into
the study. 1334 patients met inclusion criteria and were randomly assigned
to treatment with bioresorbable polymer sirolimus-eluting stents (n=884)
or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883
patients in the bioresorbable polymer sirolimus-eluting stent group and 41
(10%) of 427 patients in the durable polymer everolimus-eluting stent
group met the 12-month primary endpoint of target lesion failure (95% CI
-6.84 to -0.29, p=0.0399), with differences in target vessel myocardial
infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0.0155).
The posterior probability that the bioresorbable polymer sirolimus-eluting
stent is non-inferior to the durable polymer everolimus-eluting stent was
100% (Bayesian analysis, difference in target lesion failure frequency
-2.6% [95% credible interval -5.5 to 0.1], non-inferiority margin 3.85%,
n=2208). Interpretation The outperformance of the ultrathin, bioresorbable
polymer sirolimus-eluting stent over the durable polymer
everolimus-eluting stent in a complex patient population undergoing
percutaneous coronary intervention suggests a new direction in improving
next generation drug-eluting stent technology. Funding
BIOTRONIK.<br/>Copyright &#xa9; 2017 Elsevier Ltd

<89>
Accession Number
614116973
Title
The effect of endotracheal tubes versus laryngeal mask airways on
perioperative respiratory adverse events in infants: a randomised
controlled trial.
Source
The Lancet. 389 (10070) (pp 701-708), 2017. Date of Publication: 18 Feb
2017.
Author
Drake-Brockman T.F.E.; Ramgolam A.; Zhang G.; Hall G.L.; von
Ungern-Sternberg B.S.
Institution
(Drake-Brockman, Ramgolam, von Ungern-Sternberg) Department of Anaesthesia
and Pain Management, Princess Margaret Hospital for Children, Perth, WA,
Australia
(Drake-Brockman, von Ungern-Sternberg) School of Medicine and
Pharmacology, University of Western Australia, Perth, WA, Australia
(Zhang) Centre for Genetic Origins of Health and Disease, University of
Western Australia, Perth, WA, Australia
(Hall) Centre of Child Health Research, University of Western Australia,
Perth, WA, Australia
(Ramgolam, Hall, von Ungern-Sternberg) Children's Lung Health, Telethon
Kids Institute, Perth, WA, Australia
(Zhang) School of Public Health, Curtin University, Perth, WA, Australia
(Hall) School of Physiotherapy and Exercise Science, Curtin University,
Perth, WA, Australia
(Zhang) Centre for Genetic Origins of Health and Disease, Curtin
University, Perth, WA, Australia
Publisher
Lancet Publishing Group
Abstract
Background Perioperative respiratory adverse events (PRAE) are the most
common critical incidents in paediatric anaesthesia and occur more often
in infants. Use of laryngeal mask airways (LMAs) is associated with
reduced PRAE compared with endotracheal tubes in older children (>1 year).
We aimed to evaluate the effect of these devices on the incidence of PRAE
in infants. Methods We did a randomised controlled trial at the Princess
Margaret Hospital for Children in Perth (WA, Australia) by recruiting
infants (aged 0-12 months) undergoing general (with or without regional or
local) anaesthesia with anticipated fentanyl dose 1 mug/kg or lower for
minor elective surgery. We excluded patients contraindicated for LMA or
endotracheal tube; who had known cardiac disease or airway or thoracic
malformations; who were receiving midazolam premedication; who were
undergoing airway, thoracic, or abdomen surgery at the time of
participation; and if the parents did not speak English. Written parental
or guardian consent was obtained before enrolment. Participants were
randomly assigned (1:1), by computer-generated variable block
randomisation, to receive an LMA (PRO-Breathe, Well Lead Medical Co Ltd,
Panyu, China) or an endotracheal tube (Microcuff, Halyard Health Inc,
Atlanta, GA, USA). Sealed randomisation envelopes were used to conceal
device assignment. An interim analysis was planned once half the number of
infants needed (145) had been recruited. The primary outcome was incidence
of PRAE, assessed in the intention-to-treat population. The institutional
ethics committee at the Princess Margaret Hospital for Children granted
ethical approval (1786/EP). The trial is registered with the Australian
New Zealand Clinical Trials Registry (ACTRN12610000250033). Findings The
trial began on July 8, 2010, and was ended early on May 7, 2015, after the
interim analysis results met the study stopping rules. During this time,
239 infants were assessed and 181 eligible infants were randomly assigned
to receive an LMA (n=85) or an endotracheal tube (n=95). Four infants were
not included in the analysis (two due to cancelled procedures, one did not
meet inclusion criteria, and one with missing dataset). In the
intention-to-treat analysis, PRAE occurred in 50 (53%) infants in the
endotracheal tube group and in 15 (18%) infants in the LMA group (risk
ratio [RR] 2.94, 95% CI 1.79-4.83, p<0.0001). Laryngospasm and
bronchospasm (major PRAE) were recorded in 18 (19%) infants in the
endotracheal tube group and in three (4%) infants in the LMA group (RR
5.30, 95% CI 1.62-17.35, p=0.002). No deaths were reported. Interpretation
In infants undergoing minor elective procedures, LMAs were associated with
clinically significantly fewer PRAE and lower occurrence of major PRAE
(laryngospasm and bronchospasm) than endotracheal tubes. This difference
should be a consideration in airway device selection. Funding Princess
Margaret Hospital Foundation, National Health and Australian Medical
Research Council, Stan Perron Charitable Trust, and Callahan
Estate.<br/>Copyright &#xa9; 2017 Elsevier Ltd

<90>
Accession Number
609613559
Title
Ixmyelocel-T for patients with ischaemic heart failure: a prospective
randomised double-blind trial.
Source
The Lancet. 387 (10036) (pp 2412-2421), 2016. Date of Publication: 11 Jun
2016.
Author
Patel A.N.; Henry T.D.; Quyyumi A.A.; Schaer G.L.; Anderson R.D.; Toma C.;
East C.; Remmers A.E.; Goodrich J.; Desai A.S.; Recker D.; DeMaria A.
Institution
(Patel) University of Utah Health Care, Salt Lake City, UT, United States
(Henry) Cedars-Sinai Heart Institute, Los Angeles, CA, United States
(Quyyumi) Emory University Hospital, Atlanta, GA, United States
(Schaer) Rush University Medical Center, Chicago, IL, United States
(Anderson) University of Florida, Gainesville, FL, United States
(Toma) University of Pittsburgh, Pittsburgh, PA, United States
(East) Baylor University Medical Center, Dallas, TX, United States
(Remmers, Goodrich, Recker) Vericel Corporation, Cambridge, MA, United
States
(Desai) Brigham & Women's Hospital, Boston, MA, United States
(DeMaria) University of California San Diego, San Diego, CA, United States
Publisher
Lancet Publishing Group
Abstract
Background Ixmyelocel-T is an expanded, multicellular therapy produced
from a patient's own bone marrow by selectively expanding two key types of
bone marrow mononuclear cells: CD90+ mesenchymal stem cells and CD45+
CD14+ auto-fluorescent+ activated macrophages. Early phase clinical trials
suggest that intramyocardial delivery of ixmyelocel-T might improve
clinical, functional, symptomatic, and quality-of-life outcomes in
patients with heart failure due to ischaemic dilated cardiomyopathy. We
aimed to assess the safety and efficacy of catheter-based transendocardial
injection of ixmyelocel-T cell therapy in patients with heart failure and
reduced ejection fractions. Methods In this randomised, double-blind,
placebo-controlled phase 2B trial (ixCELL-DCM), patients from 31 sites in
North America with New York Heart Association class III or IV symptomatic
heart failure due to ischaemic dilated cardiomyopathy, who had left
ventricular ejection fraction 35% or less, an automatic implantable
cardioverter defibrillator, and who were ineligible for revascularisation
procedures were randomly assigned (1:1) to receive ixmyelocel-T or placebo
at the time of bone marrow aspiration and followed for 12 months.
Randomisation was done through an interactive (voice/web) response system.
The pharmacist, treating physician, and coordinator at each site were
unblinded, but the the follow-up team was completely blinded. The primary
endpoint was a composite of all-cause death, cardiovascular admission to
hospital, and unplanned clinic visits to treat acute decompensated heart
failure based on the blinded adjudication of an independent clinical
endpoint committee. Primary efficacy endpoint analyses and safety analyses
were done by modified intention to treat. This trial is registered with
ClinicalTrials.gov, number NCT01670981. Findings Between April 2, 2013,
and Jan 28, 2015, 126 participants were randomly assigned to receive
either ixmyelocel-T (n=66) or placebo (n=60). 114 (90%) patients comprised
the modified intention-to-treat population and 109 (87%) patients were
included in the per-protocol primary efficacy analysis (58 in the
ixmyelocel-T group and 51 in the placebo group). The primary efficacy
endpoint was observed in 47 patients: 50 events in 25 (49%) of 51 patients
in the placebo group and 38 events in 22 (38%) of 58 patients in the
ixmyelocel-T group, which represents a 37% reduction in cardiac events
compared with placebo (risk ratio 0.63 [95% CI 0.42-0.97]; p=0.0344). 41
(75%) of 51 participants in the placebo group had serious adverse events
versus 31 (53%) of 58 in the ixmyelocel-T group (p=0.0197). Interpretation
To the best of our knowledge, ixCELL-DCM is the largest cell therapy study
done in patients with heart failure so far. The transendocardial delivery
of ixmyelocel-T in patients with heart failure and reduced ejection
fraction due to ischaemic dilated cardiomyopathy resulted in a significant
reduction in adjudicated clinical cardiac events compared with placebo
leading to improved patient outcomes. Funding Vericel
Corporation.<br/>Copyright &#xa9; 2016 Elsevier Ltd

<91>
Accession Number
609467933
Title
Deferred versus conventional stent implantation in patients with
ST-segment elevation myocardial infarction (DANAMI 3-DEFER): An
open-label, randomised controlled trial.
Source
The Lancet. 387 (10034) (pp 2199-2206), 2016. Date of Publication: 28 May
2016.
Author
Kelbaek H.; Hofsten D.E.; Kober L.; Helqvist S.; Klovgaard L.; Holmvang
L.; Jorgensen E.; Pedersen F.; Saunamaki K.; De Backer O.; Bang L.E.;
Kofoed K.F.; Lonborg J.; Ahtarovski K.; Vejlstrup N.; Botker H.E.;
Terkelsen C.J.; Christiansen E.H.; Ravkilde J.; Tilsted H.-H.; Villadsen
A.B.; Aaroe J.; Jensen S.E.; Raungaard B.; Jensen L.O.; Clemmensen P.;
Grande P.; Madsen J.K.; Torp-Pedersen C.; Engstrom T.
Institution
(Kelbaek) Department of Cardiology, Roskilde Hospital, Roskilde 4000,
Denmark
(Hofsten, Kober, Helqvist, Klovgaard, Holmvang, Jorgensen, Pedersen,
Saunamaki, De Backer, Bang, Kofoed, Lonborg, Ahtarovski, Vejlstrup,
Engstrom) Department of Cardiology, Rigshospitalet, University of
Copenhagen, Copenhagen, Denmark
(Madsen, Torp-Pedersen) Department of Cardiology, Gentofte Hospital,
University of Copenhagen, Copenhagen, Denmark
(Botker, Terkelsen, Christiansen) Department of Cardiology, Skejby
Hospital, University of Aarhus, Aarhus, Denmark
(Ravkilde, Tilsted, Villadsen, Aaroe, Jensen, Raungaard) Department of
Cardiology, Aalborg University Hospital, Aalborg, Denmark
(Jensen) Department of Cardiology, Odense Hospital, University of Odense,
Odense, Denmark
(Clemmensen, Grande) Department of Cardiology, Nykobing Falster Hospital,
Denmark
Publisher
Lancet Publishing Group
Abstract
Background Despite successful treatment of the culprit artery lesion by
primary percutaneous coronary intervention (PCI) with stent implantation,
thrombotic embolisation occurs in some cases, which impairs the prognosis
of patients with ST-segment elevation myocardial infarction (STEMI). We
aimed to assess the clinical outcomes of deferred stent implantation
versus standard PCI in patients with STEMI. Methods We did this
open-label, randomised controlled trial at four primary PCI centres in
Denmark. Eligible patients (aged >18 years) had acute onset symptoms
lasting 12 h or less, and ST-segment elevation of 0.1 mV or more in at
least two or more contiguous electrocardiographic leads or newly developed
left bundle branch block. Patients were randomly assigned (1:1), via an
electronic web-based system with permuted block sizes of two to six, to
receive either standard primary PCI with immediate stent implantation or
deferred stent implantation 48 h after the index procedure if a stabilised
flow could be obtained in the infarct-related artery. The primary endpoint
was a composite of all-cause mortality, hospital admission for heart
failure, recurrent infarction, and any unplanned revascularisation of the
target vessel within 2 years' follow-up. Patients, investigators, and
treating clinicians were not masked to treatment allocation. We did
analysis by intention to treat. This trial is registered with
ClinicalTrials.gov, number NCT01435408. Findings Between March 1, 2011,
and Feb 28, 2014, we randomly assigned 1215 patients to receive either
standard PCI (n=612) or deferred stent implantation (n=603). Median
follow-up time was 42 months (IQR 33-49). Events comprising the primary
endpoint occurred in 109 (18%) patients who had standard PCI and in 105
(17%) patients who had deferred stent implantation (hazard ratio 0.99, 95%
CI 0.76-1.29; p=0.92). Procedure-related myocardial infarction, bleeding
requiring transfusion or surgery, contrast-induced nephopathy, or stroke
occurred in 28 (5%) patients in the conventional PCI group versus 27 (4%)
patients in the deferred stent implantation group, with no significant
differences between groups. Interpretation In patients with STEMI, routine
deferred stent implantation did not reduce the occurrence of death, heart
failure, myocardial infarction, or repeat revascularisation compared with
conventional PCI. Results from ongoing randomised trials might shed
further light on the concept of deferred stenting in this patient
population. Funding Danish Agency for Science, Technology and Innovation,
and Danish Council for Strategic Research.<br/>Copyright &#xa9; 2016
Elsevier Ltd.

<92>
Accession Number
609153400
Title
Invasive versus conservative strategy in patients aged 80 years or older
with non-ST-elevation myocardial infarction or unstable angina pectoris
(After Eighty study): An open-label randomised controlled trial.
Source
The Lancet. 387 (10023) (pp 1057-1065), 2016. Date of Publication: 12 Mar
2016.
Author
Tegn N.; Abdelnoor M.; Aaberge L.; Endresen K.; Smith P.; Aakhus S.;
Gjertsen E.; Dahl-Hofseth O.; Ranhoff A.H.; Gullestad L.; Bendz B.
Institution
(Tegn, Aaberge, Endresen, Aakhus, Gullestad, Bendz) Department of
Cardiology, Oslo University Hospital, Rikshospitalet, Oslo 0424, Norway
(Abdelnoor) Centre for Biostatistics and Epidemiology, Oslo University
Hospital, Oslo, Norway
(Abdelnoor) Centre for Clinical Heart Research, Oslo University Hospital,
Oslo, Norway
(Tegn, Smith, Gullestad, Bendz) Faculty of Medicine, University of Oslo,
Oslo, Norway
(Smith) Department of Cardiology, Akershus University Hospital, Lorenskog,
Norway
(Gjertsen) Department of Cardiology, Drammen Hospital, Drammen, Norway
(Dahl-Hofseth) Department of Cardiology, Lillehammer Hospital,
Lillehammer, Norway
(Ranhoff) Diakonhjemmet Hospital, Department of Clinical Science,
University of Bergen, Bergen, Norway
Publisher
Lancet Publishing Group
Abstract
Background Non-ST-elevation myocardial infarction (NSTEMI) and unstable
angina pectoris are frequent causes of hospital admission in the elderly.
However, clinical trials targeting this population are scarce, and these
patients are less likely to receive treatment according to guidelines. We
aimed to investigate whether this population would benefit from an early
invasive strategy versus a conservative strategy. Methods In this
open-label randomised controlled multicentre trial, patients aged 80 years
or older with NSTEMI or unstable angina admitted to 16 hospitals in the
South-East Health Region of Norway were randomly assigned to an invasive
strategy (including early coronary angiography with immediate assessment
for percutaneous coronary intervention, coronary artery bypass graft, and
optimum medical treatment) or to a conservative strategy (optimum medical
treatment alone). A permuted block randomisation was generated by the
Centre for Biostatistics and Epidemiology with stratification on the
inclusion hospitals in opaque concealed envelopes, and sealed envelopes
with consecutive inclusion numbers were made. The primary outcome was a
composite of myocardial infarction, need for urgent revascularisation,
stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014.
An intention-to-treat analysis was used. This study is registered with
ClinicalTrials.gov, number NCT01255540. Findings During a median follow-up
of 1.53 years of participants recruited between Dec 10, 2010, and Feb 21,
2014, the primary outcome occurred in 93 (40.6%) of 229 patients assigned
to the invasive group and 140 (61.4%) of 228 patients assigned to the
conservative group (hazard ratio [HR] 0.53 [95% CI 0.41-0.69], p=0.0001).
Five patients dropped out of the invasive group and one from the
conservative group. HRs for the four components of the primary composite
endpoint were 0.52 (0.35-0.76; p=0.0010) for myocardial infarction, 0.19
(0.07-0.52; p=0.0010) for the need for urgent revascularisation, 0.60
(0.25-1.46; p=0.2650) for stroke, and 0.89 (0.62-1.28; p=0.5340) for death
from any cause. The invasive group had four (1.7%) major and 23 (10.0%)
minor bleeding complications whereas the conservative group had four
(1.8%) major and 16 (7.0%) minor bleeding complications. Interpretation In
patients aged 80 years or more with NSTEMI or unstable angina, an invasive
strategy is superior to a conservative strategy in the reduction of
composite events. Efficacy of the invasive strategy was diluted with
increasing age (after adjustment for creatinine and effect modification).
The two strategies did not differ in terms of bleeding complications.
Funding Norwegian Health Association (ExtraStiftelsen) and Inger and John
Fredriksen Heart Foundation.<br/>Copyright &#xa9; 2016 Elsevier Ltd.

<93>
Accession Number
613466701
Title
Optical coherence tomography compared with intravascular ultrasound and
with angiography to guide coronary stent implantation (ILUMIEN III:
OPTIMIZE PCI): a randomised controlled trial.
Source
The Lancet. 388 (10060) (pp 2618-2628), 2016. Date of Publication: 26 Nov
2016.
Author
Ali Z.A.; Maehara A.; Genereux P.; Shlofmitz R.A.; Fabbiocchi F.; Nazif
T.M.; Guagliumi G.; Meraj P.M.; Alfonso F.; Samady H.; Akasaka T.; Carlson
E.B.; Leesar M.A.; Matsumura M.; Ozan M.O.; Mintz G.S.; Ben-Yehuda O.;
Stone G.W.
Institution
(Ali, Maehara, Nazif, Ben-Yehuda, Stone) New York Presbyterian Hospital
and Columbia University, New York, NY, United States
(Ali, Maehara, Genereux, Nazif, Matsumura, Ozan, Mintz, Ben-Yehuda, Stone)
Cardiovascular Research Foundation, New York, NY, United States
(Shlofmitz) St Francis Hospital, Roslyn, New York, NY, United States
(Fabbiocchi) Centro Cardiologico Monzino Istituto di Ricovero e Cura a
Carattere Scientifico, Milan, Italy
(Guagliumi) Ospedale Papa Giovanni XXIII, Bergamo, Italy
(Meraj) Northwell Health, Manhasset, New York, NY, United States
(Alfonso) Hospital Universitario de La Princesa, Madrid, Spain
(Samady) Emory University Hospital, Atlanta, GA, United States
(Akasaka) Wakayama Medical University, Wakayama, Japan
(Carlson) Eastern Cardiology, Greenville, NC, United States
(Leesar) University of Alabama, Birmingham, AB, United States
Publisher
Lancet Publishing Group
Abstract
Background Percutaneous coronary intervention (PCI) is most commonly
guided by angiography alone. Intravascular ultrasound (IVUS) guidance has
been shown to reduce major adverse cardiovascular events (MACE) after PCI,
principally by resulting in a larger postprocedure lumen than with
angiographic guidance. Optical coherence tomography (OCT) provides higher
resolution imaging than does IVUS, although findings from some studies
suggest that it might lead to smaller luminal diameters after stent
implantation. We sought to establish whether or not a novel OCT-based
stent sizing strategy would result in a minimum stent area similar to or
better than that achieved with IVUS guidance and better than that achieved
with angiography guidance alone. Methods In this randomised controlled
trial, we recruited patients aged 18 years or older undergoing PCI from 29
hospitals in eight countries. Eligible patients had one or more target
lesions located in a native coronary artery with a visually estimated
reference vessel diameter of 2.25-3.50 mm and a length of less than 40 mm.
We excluded patients with left main or ostial right coronary artery
stenoses, bypass graft stenoses, chronic total occlusions, planned
two-stent bifurcations, and in-stent restenosis. Participants were
randomly assigned (1:1:1; with use of an interactive web-based system in
block sizes of three, stratified by site) to OCT guidance, IVUS guidance,
or angiography-guided stent implantation. We did OCT-guided PCI using a
specific protocol to establish stent length, diameter, and expansion
according to reference segment external elastic lamina measurements. All
patients underwent final OCT imaging (operators in the IVUS and
angiography groups were masked to the OCT images). The primary efficacy
endpoint was post-PCI minimum stent area, measured by OCT at a masked
independent core laboratory at completion of enrolment, in all randomly
allocated participants who had primary outcome data. The primary safety
endpoint was procedural MACE. We tested non-inferiority of OCT guidance to
IVUS guidance (with a non-inferiority margin of 1.0 mm²),
superiority of OCT guidance to angiography guidance, and superiority of
OCT guidance to IVUS guidance, in a hierarchical manner. This trial is
registered with ClinicalTrials.gov, number NCT02471586. Findings Between
May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158
[35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415
final OCT acquisitions analysed for the primary endpoint (140 [34%] in the
OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography
group). The final median minimum stent area was 5.79 mm² (IQR
4.54-7.34) with OCT guidance, 5.89 mm² (4.67-7.80) with IVUS
guidance, and 5.49 mm² (4.39-6.59) with angiography guidance.
OCT guidance was non-inferior to IVUS guidance (one-sided 97.5% lower CI
-0.70 mm²; p=0.001), but not superior (p=0.42). OCT guidance
was also not superior to angiography guidance (p=0.12). We noted
procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of
146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT
vs IVUS p=0.37; OCT vs angiography p=0.37). Interpretation OCT-guided PCI
using a specific reference segment external elastic lamina-based stent
optimisation strategy was safe and resulted in similar minimum stent area
to that of IVUS-guided PCI. These data warrant a large-scale randomised
trial to establish whether or not OCT guidance results in superior
clinical outcomes to angiography guidance. Funding St Jude
Medical.<br/>Copyright &#xa9; 2016 Elsevier Ltd

<94>
Accession Number
613271791
Title
Dexmedetomidine for prevention of delirium in elderly patients after
non-cardiac surgery: a randomised, double-blind, placebo-controlled trial.
Source
The Lancet. 388 (10054) (pp 1893-1902), 2016. Date of Publication: 15 Oct
2016.
Author
Su X.; Meng Z.-T.; Wu X.-H.; Cui F.; Li H.-L.; Wang D.-X.; Zhu X.; Zhu
S.-N.; Maze M.; Ma D.
Institution
(Su, Meng, Wu, Cui, Wang) Department of Anaesthesiology and Critical Care
Medicine, Peking University First Hospital, Beijing, China
(Zhu) Department of Biostatistics, Peking University First Hospital,
Beijing, China
(Li, Zhu) Department of Critical Care Medicine, Peking University Third
Hospital, Beijing, China
(Maze) Department of Anesthesia and Perioperative Care, University of
California, San Francisco, CA, United States
(Ma) Section of Anaesthetics, Pain Management and Intensive Care,
Department of Surgery and Cancer, Imperial College London, Chelsea and
Westminster Hospital, London, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background Delirium is a postoperative complication that occurs frequently
in patients older than 65 years, and presages adverse outcomes. We
investigated whether prophylactic low-dose dexmedetomidine, a highly
selective alpha<inf>2</inf> adrenoceptor agonist, could safely decrease
the incidence of delirium in elderly patients after non-cardiac surgery.
Methods We did this randomised, double-blind, placebo-controlled trial in
two tertiary-care hospitals in Beijing, China. We enrolled patients aged
65 years or older, who were admitted to intensive care units after
non-cardiac surgery, with informed consent. We used a computer-generated
randomisation sequence (in a 1:1 ratio) to randomly assign patients to
receive either intravenous dexmedetomidine (0.1 mug/kg per h, from
intensive care unit admission on the day of surgery until 0800 h on
postoperative day 1), or placebo (intravenous normal saline).
Participants, care providers, and investigators were all masked to group
assignment. The primary endpoint was the incidence of delirium, assessed
twice daily with the Confusion Assessment Method for intensive care units
during the first 7 postoperative days. Analyses were done by
intention-to-treat and safety populations. This study is registered with
Chinese Clinical Trial Registry, www.chictr.org.cn, number
ChiCTR-TRC-10000802. Findings Between Aug 17, 2011, and Nov 20, 2013, of
2016 patients assessed, 700 were randomly assigned to receive either
placebo (n=350) or dexmedetomidine (n=350). The incidence of postoperative
delirium was significantly lower in the dexmedetomidine group (32 [9%] of
350 patients) than in the placebo group (79 [23%] of 350 patients; odds
ratio [OR] 0.35, 95% CI 0.22-0.54; p<0.0001). Regarding safety, the
incidence of hypertension was higher with placebo (62 [18%] of 350
patients) than with dexmedetomidine (34 [10%] of 350 patients; 0.50,
0.32-0.78; p=0.002). Tachycardia was also higher in patients given placebo
(48 [14%] of 350 patients) than in patients given dexmedetomidine (23 [7%]
of 350 patients; 0.44, 0.26-0.75; p=0.002). Occurrence of hypotension and
bradycardia did not differ between groups. Interpretation For patients
aged over 65 years who are admitted to the intensive care unit after
non-cardiac surgery, prophylactic low-dose dexmedetomidine significantly
decreases the occurrence of delirium during the first 7 days after
surgery. The therapy is safe. Funding Braun Anaesthesia Scientific
Research Fund and Wu Jieping Medical Foundation, Beijing, China. Study
drugs were manufactured and supplied by Jiangsu Hengrui Medicine Co, Ltd,
Jiangsu, China.<br/>Copyright &#xa9; 2016 Elsevier Ltd

<95>
Accession Number
613261923
Title
Transvenous neurostimulation for central sleep apnoea: a randomised
controlled trial.
Source
The Lancet. 388 (10048) (pp 974-982), 2016. Date of Publication: 03 Sep
2016.
Author
Costanzo M.R.; Ponikowski P.; Javaheri S.; Augostini R.; Goldberg L.;
Holcomb R.; Kao A.; Khayat R.N.; Oldenburg O.; Stellbrink C.; Abraham W.T.
Institution
(Costanzo) Advocate Heart Institute, Naperville, IL, United States
(Ponikowski) Department of Heart Diseases, Medical University, Military
Hospital, Wroclaw, Poland
(Javaheri) Bethesda North Hospital, Cincinnati, OH, United States
(Augostini, Khayat, Abraham) Ohio State University, Columbus, OH, United
States
(Goldberg) University of Pennsylvania, Philadelphia, PA, United States
(Holcomb) Independent Biostatistician, Minneapolis, MN, United States
(Kao) Mid America Heart Institute, Kansas City, MO, United States
(Oldenburg) Bad Oeynhausen Heart and Diabetes Centre, Bad Oeynhausen,
Germany
(Stellbrink) Bielefeld Medical Centre, Bielefeld, Germany
Publisher
Lancet Publishing Group
Abstract
Background Central sleep apnoea is a serious breathing disorder associated
with poor outcomes. The remede system (Respicardia Inc, Minnetonka, MN,
USA) is an implantable device which transvenously stimulates a nerve
causing diaphragmatic contraction similar to normal breathing. We
evaluated the safety and effectiveness of unilateral neurostimulation in
patients with central sleep apnoea. Methods We recruited patients from 31
hospital-based centres in Germany, Poland, and the USA in this
prospective, multicentre, randomised trial. Participants had to have been
medically stable for at least 30 days and have received appropriate
guideline recommended therapy, be aged at least 18 years, be expected to
tolerate study procedures, and willing and able to comply with study
requirements. Eligible patients with an apnoea-hypopnoea index (AHI) of at
least 20 events per h, tested by a polysomnography, underwent device
implantation and were randomly assigned (1:1) by a computer-generated
method stratified by site to either stimulation (treatment) or no
stimulation (control) for 6 months. The primary effectiveness endpoint in
the intention-to-treat population was the comparison of the proportions of
patients in the treatment versus control groups achieving a 50% or greater
AHI reduction from baseline to 6 months, measured by a full-night
polysomnography assessed by masked investigators in a core laboratory. The
primary safety endpoint of 12-month freedom from serious adverse events
related to the procedure, system, or therapy was evaluated in all
patients. This trial is active, but not recruiting, and is registered with
ClinicalTrials.gov (NCT01816776). Findings Between April 17, 2013, and May
28, 2015, we randomly assigned 151 eligible patients to the treatment
(n=73) or control (n=78) groups. In the analysis of the intention-to-treat
population, significantly more patients in the treatment group (35 [51%]
of 68) had an AHI reduction from baseline of 50% or greater at 6 months
than had those in the control group (eight [11%] of 73; difference between
groups 41%, 95% CI 25-54, p<0.0001). 138 (91%) of 151 patients had no
serious-related adverse events at 12 months. Seven (9%) cases of
related-serious adverse events occurred in the control group and six (8%)
cases were reported in the treatment group. Seven patients died (unrelated
to implant, system, or therapy), four deaths (two in treatment group and
two in control group) during the 6-month randomisation period when
neurostimulation was delivered to only the treatment group and was off in
the control group, and three deaths between 6 months and 12 months of
follow-up when all patients received neurostimulation. 27 (37%) of 73
patients in the treatment group reported non-serious therapy-related
discomfort that was resolved with simple system reprogramming in 26 (36%)
patients, but was unresolved in one (1%) patient. Interpretation
Transvenous neurostimulation significantly reduced the severity of central
sleep apnoea, including improvements in sleep metrics, and was well
tolerated. The clinically meaningful effects of the therapy are supported
by the concordant improvements in oxygenation and quality of life, making
transvenous neurostimulation a promising therapeutic approach for central
sleep apnoea. Funding Respicardia Inc.<br/>Copyright &#xa9; 2016 Elsevier
Ltd

<96>
Accession Number
613120301
Title
Early invasive versus non-invasive treatment in patients with
non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of
a prospective, randomised, multicentre study.
Source
The Lancet. 388 (10054) (pp 1903-1911), 2016. Date of Publication: 15 Oct
2016.
Author
Wallentin L.; Lindhagen L.; Arnstrom E.; Husted S.; Janzon M.; Johnsen
S.P.; Kontny F.; Kempf T.; Levin L.-A.; Lindahl B.; Stridsberg M.; Stahle
E.; Venge P.; Wollert K.C.; Swahn E.; Lagerqvist B.
Institution
(Wallentin, Lindahl, Lagerqvist) Department of Medical Sciences, Uppsala
University, Uppsala, Sweden
(Wallentin, Lindhagen, Arnstrom, Lindahl, Lagerqvist) Uppsala Clinical
Research Center, Uppsala University, Uppsala, Sweden
(Stridsberg, Venge) Department of Medical Sciences, Clinical Chemistry,
Uppsala University, Uppsala, Sweden
(Stahle) Department of Surgical Sciences, Thoracic Surgery, Uppsala
University, Uppsala, Sweden
(Husted) Medical Department, Hospital Unit West, Herning/Holstebro,
Denmark
(Janzon, Levin, Swahn) Department of Cardiology and Department of Medical
and Health Sciences, Linkoping University, Linkoping, Sweden
(Janzon, Levin) Division of Health Care Analysis, Department of Medical
and Health Sciences, Center for Medical Technology Assessment, Linkoping
University, Linkoping, Sweden
(Johnsen) Department of Clinical Epidemiology, Aarhus University Hospital,
Aarhus, Denmark
(Kontny) Stavanger University Hospital, Department of Cardiology,
Stavanger, Norway
(Kontny) Drammen Heart Center, Drammen, Norway
(Kempf, Wollert) Department of Cardiology and Angiology, Hannover Medical
School, Hannover, Germany
Publisher
Lancet Publishing Group
Abstract
Background The FRISC-II trial was the first randomised trial to show a
reduction in death or myocardial infarction with an early invasive versus
a non-invasive treatment strategy in patients with non-ST-elevation acute
coronary syndrome. Here we provide a remaining lifetime perspective on the
effects on all cardiovascular events during 15 years' follow-up. Methods
The FRISC-II prospective, randomised, multicentre trial was done at 58
Scandinavian centres in Sweden, Denmark, and Norway. Between June 17,
1996, and Aug 28, 1998, we randomly assigned (1:1) 2457 patients with
non-ST-elevation acute coronary syndrome to an early invasive treatment
strategy, aiming for revascularisation within 7 days, or a non-invasive
strategy, with invasive procedures at recurrent symptoms or severe
exercise-induced ischaemia. Plasma for biomarker analyses was obtained at
randomisation. For long-term outcomes, we linked data with national
health-care registers. The primary endpoint was a composite of death or
myocardial infarction. Outcomes were compared as the average postponement
of the next event, including recurrent events, calculated as the area
between mean cumulative count-of-events curves. Analyses were done by
intention to treat. Findings At a minimum of 15 years' follow-up on Dec
31, 2014, data for survival status and death were available for 2421 (99%)
of the initially recruited 2457 patients, and for other events after 2
years for 2182 (89%) patients. During follow-up, the invasive strategy
postponed death or next myocardial infarction by a mean of 549 days (95%
CI 204-888; p=0.0020) compared with the non-invasive strategy. This effect
was larger in non-smokers (mean gain 809 days, 95% CI 402-1175;
p<inf>interaction</inf>=0.0182), patients with elevated troponin T (778
days, 357-1165; p<inf>interaction</inf>=0.0241), and patients with high
concentrations of growth differentiation factor-15 (1356 days, 507-1650;
p<inf>interaction</inf>=0.0210). The difference was mainly driven by
postponement of new myocardial infarction, whereas the early difference in
mortality alone was not sustained over time. The invasive strategy led to
a mean of 1128 days (95% CI 830-1366) postponement of death or next
readmission to hospital for ischaemic heart disease, which was consistent
in all subgroups (p<0.0001). Interpretation During 15 years of follow-up,
an early invasive treatment strategy postponed the occurrence of death or
next myocardial infarction by an average of 18 months, and the next
readmission to hospital for ischaemic heart disease by 37 months, compared
with a non-invasive strategy in patients with non-ST-elevation acute
coronary syndrome. This remaining lifetime perspective supports that an
early invasive treatment strategy should be the preferred option in most
patients with non-ST-elevation acute coronary syndrome. Funding Swedish
Heart-Lung Foundation, Swedish Foundation for Strategic Research, and
Uppsala Clinical Research Center.<br/>Copyright &#xa9; 2016 Elsevier Ltd

<97>
Accession Number
612973121
Title
Platelet function monitoring to adjust antiplatelet therapy in elderly
patients stented for an acute coronary syndrome (ANTARCTIC): an
open-label, blinded-endpoint, randomised controlled superiority trial.
Source
The Lancet. 388 (10055) (pp 2015-2022), 2016. Date of Publication: 22 Oct
2016.
Author
Cayla G.; Cuisset T.; Silvain J.; Leclercq F.; Manzo-Silberman S.;
Saint-Etienne C.; Delarche N.; Bellemain-Appaix A.; Range G.; El Mahmoud
R.; Carrie D.; Belle L.; Souteyrand G.; Aubry P.; Sabouret P.; du Fretay
X.H.; Beygui F.; Bonnet J.-L.; Lattuca B.; Pouillot C.; Varenne O.; Boueri
Z.; Van Belle E.; Henry P.; Motreff P.; Elhadad S.; Salem J.-E.; Abtan J.;
Rousseau H.; Collet J.-P.; Vicaut E.; Montalescot G.
Institution
(Cayla, Lattuca) ACTION Study Group, Service de Cardiologie, Centre
Hospitalier Universitaire de Nimes, Universite de Montpellier, Nimes,
France
(Cuisset, Bonnet) Department of Cardiology, Centre Hospitalier
Universitaire Timone, Marseille, France
(Cuisset, Bonnet) INSERM UMR1062, INRA UMR1260, Nutrition, Obesity and
Risk of Thrombosis, Faculty of Medicine, Aix-Marseille University,
Marseille, France
(Silvain, Sabouret, Collet, Montalescot) Sorbonne Universite-Paris 06,
ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hopital
Pitie-Salpetriere (AP-HP), Paris, France
(Leclercq) Departement de Cardiologie, Centre Hospitalier Universitaire
Montpellier, Montpellier, France
(Manzo-Silberman, Henry) Service de Cardiologie, Hopital Lariboisiere,
Paris, France
(Saint-Etienne) Service de Cardiologie, Centre Hospitalier Universitaire
Tours, Tours, France
(Delarche) Hopital Francois Mitterrand, Centre Hospitalier de Pau, Pau,
France
(Bellemain-Appaix) ACTION Study Group, Service de Cardiologie, Centre
Hospitalier d'Antibes-Juans-Les-Pins, Antibes, France
(Range) Service de Cardiologie, Les Hopitaux de Chartres, Le Coudray,
Chartres, France
(El Mahmoud) Hopital Ambroise Pare, Boulogne-Billancourt, France
(Carrie) Service de Cardiologie, Centre Hospitalier Universitaire
Toulouse, Toulouse, France
(Belle) Service de Cardiologie, Centre Hospitalier d'Annecy, Annecy,
France
(Souteyrand, Motreff) Service de Cardiologie, Centre Hospitalier
Universitaire Clermont-Ferrand, Clermont-Ferrand, France
(Aubry, du Fretay, Abtan) Service de Cardiologie, Hopital Bichat Claude
Bernard, Paris, France
(Beygui) ACTION Study Group, Service de Cardiologie, Centre Hospitalier
Universitaire de Caen, Caen, France
(Pouillot) Clinique Sainte Clotilde, Saint Denis de La Reunion, La
Reunion, France
(Varenne) Service de Cardiologie, Hopital Cochin, Paris, France
(Boueri) Service de Cardiologie de Bastia, Centre Hospitalier de Bastia,
Bastia, France
(Van Belle) Service de Cardiologie, Centre Hospitalier Universitaire de
Lille, Lille, France
(Elhadad) Centre Hospitalier de Lagny Marne la Vallee, Jossigny, France
(Salem) Department of Pharmacology, CIC-1421, INSERM U1166-ICAN, Hopital
Pitie-Salpetriere (AP-HP), Paris, France
(Rousseau, Vicaut) ACTION Study Group, Unite de Recherche Clinique,
Lariboisiere, Paris, France
Publisher
Lancet Publishing Group
Abstract
Background Elderly patients are at high risk of ischaemic and bleeding
events. Platelet function monitoring offers the possibility to
individualise antiplatelet therapy to improve the therapeutic risk-benefit
ratio. We aimed to assess the effect of platelet function monitoring with
treatment adjustment in elderly patients stented for an acute coronary
syndrome. Methods We did this multicentre, open-label, blinded-endpoint,
randomised controlled superiority study at 35 centres in France. Patients
aged 75 years or older who had undergone coronary stenting for acute
coronary syndrome were randomly assigned (1:1), via a central interactive
voice-response system based on a computer-generated permuted-block
randomisation schedule with randomly selected block sizes, to receive oral
prasugrel 5 mg daily with dose or drug adjustment in case of inadequate
response (monitoring group) or oral prasugrel 5 mg daily with no
monitoring or treatment adjustment (conventional group). Randomisation was
stratified by centre. Platelet function testing was done 14 days after
randomisation and repeated 14 days after treatment adjustment in patients
in the monitoring group. Study investigators and patients were not masked
to treatment allocation, but allocation was concealed from an independent
clinical events committee responsible for endpoint adjudication. The
primary endpoint was a composite of cardiovascular death, myocardial
infarction, stroke, stent thrombosis, urgent revascularisation, and
Bleeding Academic Research Consortium-defined bleeding complications
(types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention
to treat. This trial is registered with ClinicalTrials.gov, number
NCT01538446. Findings Between March 27, 2012, and May 19, 2015, we
randomly assigned 877 patients to the monitoring group (n=442) or the
conventional group (n=435). The primary endpoint occurred in 120 (28%)
patients in the monitoring group compared with 123 (28%) patients in the
conventional group (hazard ratio [HR], 1.003, 95% CI 0.78-1.29; p=0.98).
Rates of bleeding events did not differ significantly between groups.
Interpretation Platelet function monitoring with treatment adjustment did
not improve the clinical outcome of elderly patients treated with coronary
stenting for an acute coronary syndrome. Platelet function testing is
still being used in many centres and international guidelines still
recommend platelet function testing in high-risk situations. Our study
does not support this practice or these recommendations. Funding Eli Lilly
and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and
Fondation Coeur et Recherche.<br/>Copyright &#xa9; 2016 Elsevier Ltd

<98>
Accession Number
613651342
Title
Percutaneous coronary angioplasty versus coronary artery bypass grafting
in treatment of unprotected left main stenosis (NOBLE): a prospective,
randomised, open-label, non-inferiority trial.
Source
The Lancet. 388 (10061) (pp 2743-2752), 2016. Date of Publication: 03 Dec
2016.
Author
Makikallio T.; Holm N.R.; Lindsay M.; Spence M.S.; Erglis A.; Menown
I.B.A.; Trovik T.; Eskola M.; Romppanen H.; Kellerth T.; Ravkilde J.;
Jensen L.O.; Kalinauskas G.; Linder R.B.A.; Pentikainen M.; Hervold A.;
Banning A.; Zaman A.; Cotton J.; Eriksen E.; Margus S.; Sorensen H.T.;
Nielsen P.H.; Niemela M.; Kervinen K.; Lassen J.F.; Maeng M.; Oldroyd K.;
Berg G.; Walsh S.J.; Hanratty C.G.; Kumsars I.; Stradins P.; Steigen T.K.;
Frobert O.; Graham A.N.J.; Endresen P.C.; Corbascio M.; Kajander O.;
Trivedi U.; Hartikainen J.; Anttila V.; Hildick-Smith D.; Thuesen L.;
Christiansen E.H.
Institution
(Makikallio, Niemela, Kervinen) Department of Cardiology, Oulu University
Hospital, Oulu, Finland
(Holm, Lassen, Maeng, Christiansen) Department of Cardiology, Aarhus
University Hospital, Skejby, Aarhus, Denmark
(Lindsay, Oldroyd, Berg) Department of Cardiology, Golden Jubilee National
Hospital, Clydebank, United Kingdom
(Spence, Walsh, Hanratty, Graham) Belfast Heart Centre, Belfast Trust,
Belfast, Ireland
(Erglis, Kumsars, Stradins) Latvia Centre of Cardiology, Paul Stradins
Clinical Hospital, Riga, Latvia
(Menown) Craigavon Cardiac Centre, Craigavon, Ireland
(Trovik, Steigen) Department of Cardiology, University of Northern Norway,
Tromso, Norway
(Endresen) Department of Cardiovascular Surgery, University of Northern
Norway, Tromso, Norway
(Eskola, Kajander) Heart Hospital, Tampere University Hospital, Tampere,
Finland
(Romppanen, Hartikainen) Heart Center, Kuopio University Hospital, Kuopio,
Finland
(Kellerth, Frobert) Department of Cardiology, Orebro University Hospital,
Orebro, Sweden
(Ravkilde, Thuesen) Department of Cardiology, Aalborg University Hospital,
Aalborg, Denmark
(Jensen) Department of Cardiology, Odense University Hospital, Odense,
Denmark
(Kalinauskas) Department of Cardiology, Vilnius University Hospital,
Vilnius, Lithuania
(Linder) Department of Cardiology, Danderyd Hospital, Stockholm, Sweden
(Pentikainen) Heart and Lung Center, Helsinki University Hospital,
Helsinki, Finland
(Hervold) Department of Cardiology, Oslo University Hospital,
Rikshospitalet, Oslo, Norway
(Banning) Oxford Heart Centre, Oxford, United Kingdom
(Zaman) Department of Cardiology, Freeman Hospital and Institute of
Cellular Medicine, Newcastle, United Kingdom
(Cotton) Heart and Lung Centre, New Cross Hospital, Wolverhampton, United
Kingdom
(Eriksen) Department of Cardiology, Haukeland University Hospital, Bergen,
Norway
(Margus) Department of Cardiology, East Tallinn Hospital, Tallinn, Estonia
(Sorensen) Department of Clinical Epidemiology, Aarhus University
Hospital, Aarhus, Denmark
(Sorensen) Department of Health Research and Policy (Epidemiology),
Stanford University, Stanford, CA, United States
(Nielsen) Department of Cardiac Surgery, Aarhus University Hospital,
Skejby, Aarhus, Denmark
(Corbascio) Department of Cardiology, Karolinska University Hospital,
Huddinge, Stockholm, Sweden
(Anttila) Department of Cardiac Surgery, Oulu University Hospital, Finland
(Trivedi, Hildick-Smith) Sussex Cardiac Centre, Brighton and Sussex
University Hospital, Brighton, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background Coronary artery bypass grafting (CABG) is the standard
treatment for revascularisation in patients with left main coronary artery
disease, but use of percutaneous coronary intervention (PCI) for this
indication is increasing. We aimed to compare PCI and CABG for treatment
of left main coronary artery disease. Methods In this prospective,
randomised, open-label, non-inferiority trial, patients with left main
coronary artery disease were enrolled in 36 centres in northern Europe and
randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable
angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial
infarction. Exclusion criteria were ST-elevation myocardial infarction
within 24 h, being considered too high risk for CABG or PCI, or expected
survival of less than 1 year. The primary endpoint was major adverse
cardiac or cerebrovascular events (MACCE), a composite of all-cause
mortality, non-procedural myocardial infarction, any repeat coronary
revascularisation, and stroke. Non-inferiority of PCI to CABG required the
lower end of the 95% CI not to exceed a hazard ratio (HR) of 1.35 after up
to 5 years of follow-up. The intention-to-treat principle was used in the
analysis if not specified otherwise. This trial is registered with
ClinicalTrials.gov identifier, number NCT01496651. Findings Between Dec 9,
2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI
and 603 to CABG, and 592 in each group entered analysis by intention to
treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121
events) and 19% for CABG (81 events), HR 1.48 (95% CI 1.11-1.96),
exceeding the limit for non-inferiority, and CABG was significantly better
than PCI (p=0.0066). As-treated estimates were 28% versus 19% (1.55,
1.18-2.04, p=0.0015). Comparing PCI with CABG, 5 year estimates were 12%
versus 9% (1.07, 0.67-1.72, p=0.77) for all-cause mortality, 7% versus 2%
(2.88, 1.40-5.90, p=0.0040) for non-procedural myocardial infarction, 16%
versus 10% (1.50, 1.04-2.17, p=0.032) for any revascularisation, and 5%
versus 2% (2.25, 0.93-5.48, p=0.073) for stroke. Interpretation The
findings of this study suggest that CABG might be better than PCI for
treatment of left main stem coronary artery disease. Funding Biosensors,
Aarhus University Hospital, and participating sites.<br/>Copyright &#xa9;
2016 Elsevier Ltd

<99>
Accession Number
607400485
Title
Clinical outcomes in patients with ST-segment elevation myocardial
infarction treated with everolimus-eluting stents versus bare-metal stents
(EXAMINATION): 5-year results of a randomised trial.
Source
The Lancet. 387 (10016) (pp 357-366), 2016. Date of Publication: 23 Jan
2016.
Author
Sabate M.; Brugaletta S.; Cequier A.; Iniguez A.; Serra A.;
Jimenez-Quevedo P.; Mainar V.; Campo G.; Tespili M.; Den Heijer P.;
Bethencourt A.; Vazquez N.; Van Es G.A.; Backx B.; Valgimigli M.; Serruys
P.W.
Institution
(Sabate, Brugaletta) University Hospital Clinic, Institut d'Investigacions
Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
(Cequier) University Hospital of Bellvitge, Barcelona, Spain
(Iniguez) Hospital Do Meixoeiro, Vigo, Spain
(Serra) University Hospital of Sant Pau, Barcelona, Spain
(Jimenez-Quevedo) University Hospital San Carlos, Madrid, Spain
(Mainar) Hospital General of Alicante, Alicante, Spain
(Campo) University Hospital Ferrara, Ferrara, Italy
(Tespili) University Hospital Bolognini Seriate, Bergamo, Italy
(Den Heijer) Amphia Ziekenhuis, Breda, Netherlands
(Bethencourt) Hospital Son Espases, Palma de Mallorca, Spain
(Vazquez) Hospital Juan Canalejo, A Coruna, Spain
(Van Es, Backx) Cardialysis, Rotterdam, Netherlands
(Valgimigli) Erasmus MC, Rotterdam, Netherlands
(Valgimigli) University Hospital of Bern, Inselhospital, Bern, Switzerland
(Serruys) International Centre of Circulatory Health, Imperial College
London, London, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Summary Background Data for the safety and efficacy of new-generation
drug-eluting stents at long-term follow-up, and specifically in patients
with ST-segment elevation myocardial infarction, are scarce. In the
EXAMINATION trial, we compared everolimus-eluting stents (EES) with
bare-metal stents (BMS) in an all-comer population with ST-segment
elevation myocardial infarction. In this study, we assessed the 5-year
outcomes of the population in the EXAMINATION trial. Methods In the
multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands,
patients with ST-segment elevation myocardial infarction were randomly
assigned in a 1:1 ratio to receive EES or BMS. The random allocation
schedule was computer-generated and central randomisation (by telephone)
was used to allocate patients in blocks of four or six, stratified by
centre. Patients were masked to treatment assignment. At 5 years, we
assessed the combined patient-oriented outcome of all-cause death, any
myocardial infarction, or any revascularisation. Analysis was by intention
to treat. This trial is registered with ClinicalTrials.gov, number
NCT00828087. Findings 1498 patients were randomly assigned to receive
either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up
data were obtained for 731 patients treated with EES and 727 treated with
BMS (97% of both groups). The patient-oriented endpoint occurred in 159
(21%) patients in the EES group versus 192 (26%) in the BMS group (hazard
ratio 0.80, 95% CI 0.65-0.98; p=0.033). This difference was mainly driven
by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0.72,
0.52-0.10; p=0.047). Interpretation Our findings should be taken as a
point of reference for the assessment of new bioresorbable polymer-based
metallic stents or bioresorbable scaffolds in patients with ST-segment
elevation myocardial infarction. Funding Spanish Heart
Foundation.<br/>Copyright &#xa9; 2016 Elsevier Ltd.

<100>
Accession Number
607143255
Title
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes
after percutaneous coronary intervention (REGULATE-PCI): A randomised
clinical trial.
Source
The Lancet. 387 (10016) (pp 349-356), 2016. Date of Publication: 23 Jan
2016.
Author
Lincoff A.M.; Mehran R.; Povsic T.J.; Zelenkofske S.L.; Huang Z.;
Armstrong P.W.; Steg P.G.; Bode C.; Cohen M.G.; Buller C.; Laanmets P.;
Valgimigli M.; Marandi T.; Fridrich V.; Cantor W.J.; Merkely B.;
Lopez-Sendon J.; Cornel J.H.; Kasprzak J.D.; Aschermann M.; Guetta V.;
Morais J.; Sinnaeve P.R.; Huber K.; Stables R.; Sellers M.A.; Borgman M.;
Glenn L.; Levinson A.I.; Lopes R.D.; Hasselblad V.; Becker R.C.; Alexander
J.H.
Institution
(Lincoff, Borgman) Cleveland Clinic Coordinating Center for Clinical
Research (C5Research), Department of Cardiovascular Medicine, Cleveland
Clinic, Cleveland, OH 44195, United States
(Mehran) Mount Sinai School of Medicine, New York, NY, United States
(Povsic, Huang, Sellers, Lopes, Hasselblad, Alexander) Duke Clinical
Research Institute, Duke Medicine, Durham, NC, United States
(Zelenkofske, Glenn) Regado Biosciences, Basking Ridge, NJ, United States
(Armstrong) Canadian VIGOUR Centre, University of Alberta, Edmonton, AB,
Canada
(Steg) Universite Paris-Diderot, Sorbonne Paris Cite, Paris, France
(Bode) University of Freiburg, Freiburg, Germany
(Cohen) University of Miami, Miller School of Medicine, Miami, FL, United
States
(Buller) St Michael's Hospital, Toronto, ON, Canada
(Laanmets, Marandi) North Estonia Medical Centre, Tallinn, Estonia
(Valgimigli) University Hospital of Ferrara, Institute of Cardiology,
Ferrara, Italy
(Fridrich) National Institute of Cardiovascular Diseases, Bratislava,
Slovakia
(Cantor) Southlake Regional Health Centre, Newmarket, ON, Canada
(Merkely) Semmelweis University Heart, Vascular Center, Budapest, Hungary
(Lopez-Sendon) Hospital Universitario la Paz, IdiPaz, Madrid, Spain
(Cornel) Medical Center Alkmaar, Alkmaar, Netherlands
(Kasprzak) Medical University of Lodz, Bieganski Hospital, Lodz, Poland
(Aschermann) General University Hospital, Prague, Czechia
(Guetta) Heart Institute Sheba Medical Center, Tel Aviv University, Tel
Hashomer, Israel
(Morais) Santo Andre's Hospital, Leiria, Portugal
(Sinnaeve) University Hospitals Leuven, Campus Gasthuisberg, Leuven,
Belgium
(Huber) Wilhelminen Hospital, Vienna, Austria
(Stables) Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
(Levinson) Perelman School of Medicine, University of Pennsylvania,
Philadelphia, PA, United States
(Becker) University of Cincinnati, College of Medicine, Cincinnati, OH,
United States
Publisher
Lancet Publishing Group
Abstract
Summary Background REG1 is a novel anticoagulation system consisting of
pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and
anivamersen, a complementary sequence reversal oligonucleotide. We tested
the hypothesis that near complete inhibition of factor IXa with
pegnivacogin during percutaneous coronary intervention, followed by
partial reversal with anivamersen, would reduce ischaemic events compared
with bivalirudin, without increasing bleeding. Methods We did a
randomised, open-label, active-controlled, multicentre, superiority trial
to compare REG1 with bivalirudin at 225 hospitals in North America and
Europe. We planned to randomly allocate 13200 patients undergoing
percutaneous coronary intervention in a 1:1 ratio to either REG1
(pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80%
reversal with anivamersen after percutaneous coronary intervention) or
bivalirudin. Exclusion criteria included ST segment elevation myocardial
infarction within 48 h. The primary efficacy endpoint was the composite of
all-cause death, myocardial infarction, stroke, and unplanned target
lesion revascularisation by day 3 after randomisation. The principal
safety endpoint was major bleeding. Analysis was by intention to treat.
This trial is registered at ClinicalTrials.gov, identifier NCT01848106.
The trial was terminated early after enrolment of 3232 patients due to
severe allergic reactions. Findings 1616 patients were allocated REG1 and
1616 were assigned bivalirudin, of whom 1605 and 1601 patients,
respectively, received the assigned treatment. Severe allergic reactions
were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%)
of 1601 patients treated with bivalirudin. The composite primary endpoint
did not differ between groups, with 108 (7%) of 1616 patients assigned
REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary
endpoint event (odds ratio [OR] 1.05, 95% CI 0.80-1.39; p=0.72). Major
bleeding was similar between treatment groups (seven [<1%] of 1605
receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3.49, 95%
CI 0.73-16.82; p=0.10), but major or minor bleeding was increased with
REG1 (104 [6%] vs 65 [4%]; 1.64, 1.19-2.25; p=0.002). Interpretation The
reversible factor IXa inhibitor REG1, as currently formulated, is
associated with severe allergic reactions. Although statistical power was
limited because of early termination, there was no evidence that REG1
reduced ischaemic events or bleeding compared with bivalirudin. Funding
Regado Biosciences Inc.<br/>Copyright &#xa9; 2016 Elsevier Ltd.

<101>
Accession Number
607129815
Title
Everolimus-eluting bioresorbable vascular scaffolds versus
everolimus-eluting metallic stents: A meta-analysis of randomised
controlled trials.
Source
The Lancet. 387 (10018) (pp 537-544), 2016. Date of Publication: 06 Feb
2016.
Author
Cassese S.; Byrne R.A.; Ndrepepa G.; Kufner S.; Wiebe J.; Repp J.;
Schunkert H.; Fusaro M.; Kimura T.; Kastrati A.
Institution
(Cassese, Byrne, Ndrepepa, Kufner, Wiebe, Repp, Schunkert, Fusaro,
Kastrati) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munich 80636, Germany
(Schunkert, Kastrati) DZHK (German Centre for Cardiovascular Research),
Partner Site Munich Heart Alliance, Munich, Germany
(Kimura) Department of Cardiovascular Medicine, Kyoto University Hospital,
Kyoto, Japan
Publisher
Lancet Publishing Group
Abstract
Background Bioresorbable coronary stents might improve outcomes of
patients treated with percutaneous coronary interventions. The
everolimus-eluting bioresorbable vascular scaffold is the most studied of
these stent platforms; however, its performance versus everolimus-eluting
metallic stents remains poorly defined. We aimed to assess the efficacy
and safety of everolimus-eluting bioresorbable vascular scaffolds versus
everolimus-eluting metallic stents in patients with ischaemic heart
disease treated with percutaneous revascularisation. Methods We searched
Medline, Embase, the Cochrane Central Register of Controlled Trials
(CENTRAL), scientific sessions abstracts, and relevant websites for
randomised trials investigating everolimus-eluting bioresorbable vascular
scaffolds versus everolimus-eluting metallic stents published or posted
between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was
target lesion revascularisation and the primary safety outcome was
definite or probable stent (scaffold) thrombosis. Secondary outcomes were
target lesion failure (the composite of cardiac death, target-vessel
myocardial infarction, or ischaemia-driven target lesion
revascularisation), myocardial infarction, death, and in-device late lumen
loss. We derived odds ratios (ORs) and weighted mean differences with 95%
CIs, and calculated the risk estimates for the main outcomes according to
a random-effects model. This study is registered with PROSPERO, number
CRD42015026374. Findings We included six trials, comprising data for 3738
patients randomised to receive percutaneous coronary intervention with
either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or
an everolimus-eluting metallic stent (n=1401). Median follow-up was 12
months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds
had a similar risk of target lesion revascularisation (OR 0.97 [95% CI
0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21),
myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95
[0.45-2.00]; p=0.89) as those treated with metallic stents. Patients
treated with a bioresorbable vascular scaffold had a higher risk of
definite or probable stent thrombosis than those treated with a metallic
stent (OR 1.99 [95% CI 1.00-3.98]; p=0.05), with the highest risk between
1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions
treated with a bioresorbable vascular scaffold had greater in-device late
lumen loss than those treated with a metallic stent (weighted mean
difference 0.08 [95% CI 0.05-0.12]; p<0.0001). Interpretation Compared
with everolimus-eluting metallic stents, everolimus-eluting bioresorbable
vascular scaffolds had similar rates of repeat revascularisation at 1 year
of follow-up, despite inferior mid-term angiographic performance. However,
patients treated with a bioresorbable vascular scaffold had an increased
risk of subacute stent thrombosis. Studies with extended follow-up in a
larger number of patients are needed to fully assess the long-term
advantages of everolimus-eluting bioresorbable vascular scaffolds. Funding
None.<br/>Copyright &#xa9; 2016 Elsevier Ltd.

<102>
Accession Number
607407123
Title
Ranolazine in patients with incomplete revascularisation after
percutaneous coronary intervention (RIVER-PCI): A multicentre, randomised,
double-blind, placebo-controlled trial.
Source
The Lancet. 387 (10014) (pp 136-145), 2016. Date of Publication: 09 Jan
2016.
Author
Weisz G.; Genereux P.; Iniguez A.; Zurakowski A.; Shechter M.; Alexander
K.P.; Dressler O.; Osmukhina A.; James S.; Ohman E.M.; Ben-Yehuda O.;
Farzaneh-Far R.; Stone G.W.
Institution
(Weisz) Department of Cardiology, Shaare Zedek Medical Center, Jerusalem
91031, Israel
(Weisz) New York Presbyterian Hospital, Columbia University Medical
Center, New York, NY, United States
(Stone) Cardiovascular Research Foundation, New York, NY, United States
(Weisz, Genereux, Dressler, Ben-Yehuda, Stone) Hopital du Sacre-Coeur de
Montreal, Universite de Montreal, Montreal, QC, Canada
(Genereux) Hospital de Meixoeiro, Vigo, Spain
(Iniguez) American Heart of Poland SA, Katowice, Poland
(Zurakowski) Chaim Sheba Medical Center, Tel Hashomer, Israel
(Shechter) Duke Clinical Research Institute, Duke University, Durham, NC,
United States
(Alexander, Ohman) Gilead Sciences, Foster City, CA, United States
(Osmukhina, James, Farzaneh-Far) Department of Medical Sciences,
Cardiology, Uppsala University, Uppsala, Sweden
Publisher
Lancet Publishing Group
Abstract
Background Incomplete revascularisation is common after percutaneous
coronary intervention and is associated with increased mortality and
adverse cardiovascular events. We aimed to assess whether adjunctive
anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis
of patients with incomplete revascularisation after percutaneous coronary
intervention. Methods We performed this multicentre, randomised,
parallel-group, double-blind, placebo-controlled, event-driven trial at
245 centres in 15 countries in Europe, Israel, Russia, and the USA.
Patients (aged <=18 years) with a history of chronic angina with
incomplete revascularisation after percutaneous coronary intervention
(defined as one or more lesions with <=50% diameter stenosis in a coronary
artery <=2 mm diameter) were randomly assigned (1:1), via an interactive
web-based block randomisation system (block sizes of ten), to receive
either twice-daily oral ranolazine 1000 mg or matching placebo.
Randomisation was stratified by diabetes history (presence vs absence) and
acute coronary syndrome presentation (acute coronary syndrome vs non-acute
coronary syndrome). Study investigators, including all research teams, and
patients were masked to treatment allocation. The primary endpoint was
time to first occurrence of ischaemia-driven revascularisation or
ischaemia-driven hospitalisation without revascularisation. Analysis was
by intention to treat. This study is registered at ClinicalTrials.gov,
number NCT01442038. Findings Between Nov 3, 2011, and May 27, 2013, we
randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo
(n=1319); 2604 (98%) patients comprised the full analysis set. After a
median follow-up of 643 days (IQR 575-758), the composite primary endpoint
occurred in 345 (26%) patients assigned to ranolazine and 364 (28%)
patients assigned to placebo (hazard ratio 0.95, 95% CI 0.82-1.10;
p=0.48). Incidence of ischaemia-driven revascularisation and
ischaemia-driven hospitalisation did not differ significantly between
groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients
in the placebo group discontinued study drug because of an adverse event
(p=0.04). Interpretation Ranolazine did not reduce the composite rate of
ischaemia-driven revascularisation or hospitalisation without
revascularisation in patients with a history of chronic angina who had
incomplete revascularisation after percutaneous coronary intervention.
Further studies are warranted to establish whether other treatment could
be effective in improving the prognosis of high-risk patients in this
population. Funding Gilead Sciences, Menarini.<br/>Copyright &#xa9; 2016
Elsevier Ltd.

<103>
Accession Number
606357917
Title
Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): A
randomised, double-blind, placebo-controlled trial.
Source
The Lancet. 386 (10000) (pp 1243-1253), 2015. Date of Publication: 26 Sep
2015.
Author
Whitlock R.P.; Devereaux P.J.; Teoh K.H.; Lamy A.; Vincent J.; Pogue J.;
Paparella D.; Sessler D.I.; Karthikeyan G.; Villar J.C.; Zuo Y.; Avezum
A.; Quantz M.; Tagarakis G.I.; Shah P.J.; Abbasi S.H.; Zheng H.; Pettit
S.; Chrolavicius S.; Yusuf S.
Institution
(Whitlock, Devereaux, Lamy, Vincent, Pogue, Pettit, Chrolavicius, Yusuf)
Population Health Research Institute, Hamilton Health Sciences and
McMaster University, Hamilton, ON L8L 2X2, Canada
(Whitlock, Lamy) Department of Surgery, McMaster University, Hamilton, ON,
Canada
(Whitlock, Devereaux, Lamy) Department of Clinical Epidemiology and
Biostatistics, McMaster University, Hamilton, ON, Canada
(Devereaux, Yusuf) Department of Medicine, McMaster University, Hamilton,
ON, Canada
(Teoh) Department of Surgery, Southlake Regional Health Centre, Newmarket,
ON, Canada
(Paparella) University of Bari Aldo Moro, Bari, Italy
(Sessler) Department of Outcomes Research, Cleveland Clinic, Cleveland,
OH, United States
(Karthikeyan) All India Institute of Medical Sciences, New Delhi, India
(Villar) Fundacion Cardio Infantil, Instituto de Cardiologia, Bogota,
Colombia
(Zuo) Department of Anesthesiology, West China Hospital, Sichuan
University, Chengdu, China
(Avezum) Divisao de Pesquisa, Instituto Dante Pazzanese de Cardiologia,
Sao Paulo, Brazil
(Quantz) London Health Sciences Centre, London, ON, Canada
(Tagarakis) Department of Cardiovascular and Thoracic Surgery, University
of Thessaly, Larissa, Greece
(Shah) Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD,
Australia
(Abbasi) Tehran Heart Centre, Tehran University of Medical Sciences,
Tehran, Iran, Islamic Republic of
(Zheng) First Teaching Hospital, Xinjiang Medical University, Urumqi,
China
Publisher
Lancet Publishing Group
Abstract
Background Cardiopulmonary bypass initiates a systemic inflammatory
response syndrome that is associated with postoperative morbidity and
mortality. Steroids suppress inflammatory responses and might improve
outcomes in patients at high risk of morbidity and mortality undergoing
cardiopulmonary bypass. We aimed to assess the effects of steroids in
patients at high risk of morbidity and mortality undergoing
cardiopulmonary bypass. Methods The Steroids In caRdiac Surgery (SIRS)
study is a double-blind, randomised, controlled trial. We used a central
computerised phone or interactive web system to randomly assign (1:1)
patients at high risk of morbidity and mortality from 80 hospital or
cardiac surgery centres in 18 countries undergoing cardiac surgery with
the use of cardiopulmonary bypass to receive either methylprednisolone
(250 mg at anaesthetic induction and 250 mg at initiation of
cardiopulmonary bypass) or placebo. Patients were assigned with block
randomisation with random block sizes of 2, 4, or 6 and stratified by
centre. Patients aged 18 years or older were eligible if they had a
European System for Cardiac Operative Risk Evaluation of at least 6.
Patients were excluded if they were taking or expected to receive systemic
steroids in the immediate postoperative period or had a history of
bacterial or fungal infection in the preceding 30 days. Patients,
caregivers, and those assessing outcomes were masked to allocation. The
primary outcomes were 30-day mortality and a composite of death and major
morbidity (ie, myocardial injury, stroke, renal failure, or respiratory
failure) within 30 days, both analysed by intention to treat. Safety
outcomes were also analysed by intention to treat. This study is
registered with ClinicalTrials.gov, number NCT00427388. Findings Patients
were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day
data was available for all 7507 patients randomly assigned to
methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone,
compared with placebo, did not reduce the risk of death at 30 days (154
[4%] vs 177 [5%] patients; relative risk [RR] 0.87, 95% CI 0.70-1.07,
p=0.19) or the risk of death or major morbidity (909 [24%] vs 885 [24%];
RR 1.03, 95% CI 0.95-1.11, p=0.52). The most common safety outcomes in the
methylprednisolone and placebo group were infection (465 [12%] vs 493
[13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295
[8%] vs 289 [8%]). Interpretation Methylprednisolone did not have a
significant effect on mortality or major morbidity after cardiac surgery
with cardiopulmonary bypass. The SIRS trial does not support the routine
use of methylprednisolone for patients undergoing cardiopulmonary bypass.
Funding Canadian Institutes of Health Research.<br/>Copyright &#xa9; 2015
Elsevier Ltd.

<104>
Accession Number
605511796
Title
Complete revascularisation versus treatment of the culprit lesion only in
patients with ST-segment elevation myocardial infarction and multivessel
disease (DANAMI-3 - PRIMULTI): An open-label, randomised controlled trial.
Source
The Lancet. 386 (9994) (pp 665-671), 2015. Date of Publication: 15 Aug
2015.
Author
Engstrom T.; Kelbaek H.; Helqvist S.; Hofsten D.E.; Klovgaard L.; Holmvang
L.; Jorgensen E.; Pedersen F.; Saunamaki K.; Clemmensen P.; De Backer O.;
Ravkilde J.; Tilsted H.-H.; Villadsen A.B.; Aaroe J.; Jensen S.E.;
Raungaard B.; Kober L.
Institution
(Engstrom, Kelbaek, Helqvist, Hofsten, Klovgaard, Holmvang, Jorgensen,
Pedersen, Saunamaki, Clemmensen, De Backer, Kober) Department of
Cardiology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
(Ravkilde, Tilsted, Villadsen, Aaroe, Jensen, Raungaard) Department of
Cardiology, Aalborg University Hospital, Aalborg, Denmark
(Kelbaek) Department of Cardiology, Roskilde Hospital, Roskilde DK-4000,
Denmark
Publisher
Lancet Publishing Group
Abstract
Summary Background Patients with acute ST-segment elevation myocardial
infarction (STEMI) and multivessel coronary disease have a worse prognosis
compared with individuals with single-vessel disease. We aimed to study
the clinical outcome of patients with STEMI treated with fractional flow
reserve (FFR)-guided complete revascularisation versus treatment of the
infarct-related artery only. Methods We undertook an open-label,
randomised controlled trial at two university hospitals in Denmark.
Patients presenting with STEMI who had one or more clinically significant
coronary stenosis in addition to the lesion in the infarct-related artery
were included. After successful percutaneous coronary intervention (PCI)
of the infarct-related artery, patients were randomly allocated (in a 1:1
ratio) either no further invasive treatment or complete FFR-guided
revascularisation before discharge. Randomisation was done electronically
via a web-based system in permuted blocks of varying size by the clinician
who did the primary PCI. All patients received best medical treatment. The
primary endpoint was a composite of all-cause mortality, non-fatal
reinfarction, and ischaemia-driven revascularisation of lesions in
non-infarct-related arteries and was assessed when the last enrolled
patient had been followed up for 1 year. Analysis was on an
intention-to-treat basis. This trial is registered with
ClinicalTrials.gov, number NCT01960933. Findings From March, 2011, to
February, 2014, we enrolled 627 patients to the trial; 313 were allocated
no further invasive treatment after primary PCI of the infarct-related
artery only and 314 were assigned complete revascularisation guided by FFR
values. Median follow-up was 27 months (range 12-44 months). Events
comprising the primary endpoint were recorded in 68 (22%) patients who had
PCI of the infarct-related artery only and in 40 (13%) patients who had
complete revascularisation (hazard ratio 0.56, 95% CI 0.38-0.83; p=0.004).
Interpretation In patients with STEMI and multivessel disease, complete
revascularisation guided by FFR measurements significantly reduces the
risk of future events compared with no further invasive intervention after
primary PCI. This effect is driven by significantly fewer repeat
revascularisations, because all-cause mortality and non-fatal reinfarction
did not differ between groups. Thus, to avoid repeat revascularisation,
patients can safely have all their lesions treated during the index
admission. Future studies should clarify whether complete
revascularisation should be done acutely during the index procedure or at
later time and whether it has an effect on hard endpoints. Funding Danish
Agency for Science, Technology and Innovation and Danish Council for
Strategic Research.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<105>
Accession Number
601131269
Title
A bioresorbable everolimus-eluting scaffold versus a metallic
everolimus-eluting stent for ischaemic heart disease caused by de-novo
native coronary artery lesions (ABSORB II): An interim 1-year analysis of
clinical and procedural secondary outcomes from a randomised controlled
trial.
Source
The Lancet. 385 (9962) (pp 43-54), 2015. Date of Publication: 03 Jan 2015.
Author
Serruys P.W.; Chevalier B.; Dudek D.; Cequier A.; Carrie D.; Iniguez A.;
Dominici M.; Van Der Schaaf R.J.; Haude M.; Wasungu L.; Veldhof S.; Peng
L.; Staehr P.; Grundeken M.J.; Ishibashi Y.; Garcia-Garcia H.M.; Onuma Y.
Institution
(Serruys) International Centre for Cardiovascular Health, Imperial
College, London, United Kingdom
(Chevalier) Institut Jacques Cartier, Massy, France
(Dudek) Jagiellonian University, Department of Cardiology and Cardio
Vascular Interventions, University Hospital, Krakow, Poland
(Cequier) Bellvitge University Hospital, Barcelona, Spain
(Carrie) Hopital de Rangueil, Toulouse, France
(Iniguez) Hospital de Meixoeiro, Vigo, Spain
(Dominici) S Maria University Hospital, Terni, Italy
(Van Der Schaaf) OLVG, Amsterdam, Netherlands
(Haude) Stadtisches Kliniken Neuss Lukaskrankenhaus GmbH, Neuss, Germany
(Wasungu, Veldhof) Abbott Vascular, Diegem, Belgium
(Peng, Staehr) Abbott Vascular, Santa Clara, CA, United States
(Grundeken) Academic Medical Centre, Amsterdam, Netherlands
(Ishibashi, Garcia-Garcia, Onuma) Erasmus MC, Rotterdam, Netherlands
(Garcia-Garcia, Onuma) Cardialysis BV, Rotterdam, Netherlands
Publisher
Lancet Publishing Group
Abstract
Background Despite rapid dissemination of an everolimus-eluting
bioresorbable scaffold for treatment for coronary artery disease, no data
from comparisons with its metallic stent counterpart are available. In a
randomised controlled trial we aimed to compare an everolimus-eluting
bioresorbable scaffold with an everolimus-eluting metallic stent. Here we
report secondary clinical and procedural outcomes after 1 year of
follow-up. Methods In a single-blind, multicentre, randomised trial, we
enrolled eligible patients aged 18-85 years with evidence of myocardial
ischaemia and one or two de-novo native lesions in different epicardial
vessels. We randomly assigned patients in a 2:1 ratio to receive treatment
with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott
Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting
metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA).
Randomisation was stratified by diabetes status and number of planned
target lesions. The co-primary endpoints of this study are vasomotion
(change in mean lumen diameter before and after nitrate administration at
3 years) and difference between minimum lumen diameter (after nitrate
administration) after the index procedure and at 3 years. Secondary
endpoints were procedural performance assessed by quantitative angiography
and intravascular ultrasound; composite clinical endpoints based on death,
myocardial infarction, and coronary revascularisation; device and
procedural success; and angina status assessed by the Seattle Angina
Questionnaire and exercise testing at 6 and 12 months. Cumulative angina
rate based on adverse event reporting was analysed post hoc. This trial is
registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov
28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned
them to the bioresorbable scaffold group (335 patients, 364 lesions) or
the metallic stent group (166 patients, 182 lesions). Dilatation pressure
and balloon diameter at the highest pressure during implantation or
postdilatation were higher and larger in the metallic stent group, whereas
the acute recoil post implantation was similar (0.19 mm for both, p=0.85).
Acute lumen gain was lower for the bioresorbable scaffold by quantitative
coronary angiography (1.15 mm vs 1.46 mm, p<0.0001) and quantitative
intravascular ultrasound (2.85 mm² vs 3.60 mm²,
p<0.0001), resulting in a smaller lumen diameter or area post procedure.
At 1 year, however, cumulative rates of first new or worsening angina from
adverse event reporting were lower (72 patients [22%] in the bioresorbable
scaffold group vs 50 [30%] in the metallic stent group, p=0.04), whereas
performance during maximum exercise and angina status by SAQ were similar.
The 1-year composite device orientated endpoint was similar between the
bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five
patients [3%], p=0.35). Three patients in the bioresorbable scaffold group
had definite or probable scaffold thromboses (one definite acute, one
definite sub-acute, and one probable late), compared with no patients in
the metallic stent group. There were 17 (5%) major cardiac adverse events
in the bioresorbable scaffold group compared with five (3%) events in the
metallic stent group, with the most common adverse events being myocardial
infarction (15 cases [4%] vs two cases [1%], respectively) and clinically
indicated target-lesion revascularisation (four cases [1%] vs three cases
[2%], respectively). Interpretation The everolimus-eluting bioresorbable
scaffold showed similar 1-year composite secondary clinical outcomes to
the everolimus-eluting metallic stent. Funding Abbott
Vascular.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<106>
Accession Number
603047075
Title
Radial versus femoral access in patients with acute coronary syndromes
undergoing invasive management: A randomised multicentre trial.
Source
The Lancet. 385 (9986) (pp 2465-2476), 2015. Date of Publication: 20 Jun
2015.
Author
Valgimigli M.; Gagnor A.; Calabro P.; Frigoli E.; Leonardi S.; Zaro T.;
Rubartelli P.; Briguori C.; Ando G.; Repetto A.; Limbruno U.; Cortese B.;
Sganzerla P.; Lupi A.; Galli M.; Colangelo S.; Ierna S.; Ausiello A.;
Presbitero P.; Sardella G.; Varbella F.; Esposito G.; Santarelli A.;
Tresoldi S.; Nazzaro M.; Zingarelli A.; De Cesare N.; Rigattieri S.; Tosi
P.; Palmieri C.; Brugaletta S.; Rao S.V.; Heg D.; Rothenbuhler M.; Vranckx
P.; Juni P.
Institution
(Valgimigli) Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
(Gagnor, Frigoli, Varbella) Cardiology Unit, ASL Torino 3, Ospedali
Riuniti di Rivoli, Turin, Italy
(Calabro) Division of Cardiology, Second University of Naples, Department
of Cardiothoracic Sciences, Naples, Italy
(Frigoli) EUSTRATEGY Association, Forli', Italy
(Leonardi, Repetto) UOC Cardiologia, Fondazione IRCCS Policlinico San
Matteo, Dipartimento CardioToracoVascolare, Pavia, Italy
(Zaro) A.O. Ospedale Civile di Vimercate (MB), Vimercate, Italy
(Rubartelli) Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa,
Italy
(Briguori) Clinica Mediterranea, Naples, Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico Gaetano Martino,
University of Messina, Messina, Italy
(Limbruno) UO Cardiologia, ASL 9 Grosseto, Grosseto, Italy
(Cortese) Ospedale Fate Bene Fratelli, Milan, Italy
(Sganzerla) AO Ospedale Treviglio-Caravaggio, Treviglio, BG, Italy
(Lupi) University Hospital Maggiore della Carita, Novara, Italy
(Galli) Ospedaliera sant'Anna, Como, Italy
(Colangelo) San Giovanni Bosco Hospital, Turin, Italy
(Ierna) Ospedale Sirai - Carbonia, Carbonia, Italy
(Ausiello) Casa di Cura Villa Verde, Taranto, Italy
(Presbitero) IRCCS Humanitas, Rozzano, Italy
(Sardella) Department of Cardiovascular, Policlinico Umberto i Sapienza
University of Rome, Respiratory, Nephrologic, Anesthesiologic and
Geriatric Sciences, Rome, Italy
(Esposito) Division of Cardiology, Department of Advanced Biomedical
Sciences, Federico II University of Naples, Naples, Italy
(Santarelli) Cardiovascular Department, Infermi Hospital, Rimini, Italy
(Tresoldi) A.O. Ospedale di Desio (MB), Desio, Italy
(Nazzaro) San Camillo-Forlanini, Rome, Italy
(Zingarelli) IRCCS AOU San Martino, Genoa, Italy
(De Cesare) Policlinico San Marco, Zingonia, Italy
(Rigattieri) Interventional Cardiology Sandro Pertini Hospital, Rome,
Italy
(Tosi) Mater Salutis Hospital-Legnago, Verona, Italy
(Palmieri) Ospedale Pasquinucci, Massa, Italy
(Brugaletta) Hospital Clinic, Department of Cardiology, University of
Barcelona, Barcelona, Spain
(Rao) Duke Clinical Research Institute, Durham, NC, United States
(Vranckx) Department of Cardiology and Critical Care Medicine, Jessa
Ziekenhuis, Hartcentrum Hasselt, Hasselt, Belgium
(Heg, Rothenbuhler, Juni) Clinical Trials Unit, University of Bern, Bern,
Switzerland
(Juni) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Heg) Institute of Social and Preventive Medicine, University of Bern,
Bern, Switzerland
Publisher
Lancet Publishing Group
Abstract
Summary Background It is unclear whether radial compared with femoral
access improves outcomes in unselected patients with acute coronary
syndromes undergoing invasive management. Methods We did a randomised,
multicentre, superiority trial comparing transradial against transfemoral
access in patients with acute coronary syndrome with or without ST-segment
elevation myocardial infarction who were about to undergo coronary
angiography and percutaneous coronary intervention. Patients were randomly
allocated (1:1) to radial or femoral access with a web-based system. The
randomisation sequence was computer generated, blocked, and stratified by
use of ticagrelor or prasugrel, type of acute coronary syndrome
(ST-segment elevation myocardial infarction, troponin positive or
negative, non-ST-segment elevation acute coronary syndrome), and
anticipated use of immediate percutaneous coronary intervention. Outcome
assessors were masked to treatment allocation. The 30-day coprimary
outcomes were major adverse cardiovascular events, defined as death,
myocardial infarction, or stroke, and net adverse clinical events, defined
as major adverse cardiovascular events or Bleeding Academic Research
Consortium (BARC) major bleeding unrelated to coronary artery bypass graft
surgery. The analysis was by intention to treat. The two-sided alpha was
prespecified at 0.025. The trial is registered at ClinicalTrials.gov,
number NCT01433627. Findings We randomly assigned 8404 patients with acute
coronary syndrome, with or without ST-segment elevation, to radial (4197)
or femoral (4207) access for coronary angiography and percutaneous
coronary intervention. 369 (8.8%) patients with radial access had major
adverse cardiovascular events, compared with 429 (10.3%) patients with
femoral access (rate ratio [RR] 0.85, 95% CI 0.74-0.99; p=0.0307),
non-significant at alpha of 0.025. 410 (9.8%) patients with radial access
had net adverse clinical events compared with 486 (11.7%) patients with
femoral access (0.83, 95% CI 0.73-0.96; p=0.0092). The difference was
driven by BARC major bleeding unrelated to coronary artery bypass graft
surgery (1.6% vs 2.3%, RR 0.67, 95% CI 0.49-0.92; p=0.013) and all-cause
mortality (1.6% vs 2.2%, RR 0.72, 95% CI 0.53-0.99; p=0.045).
Interpretation In patients with acute coronary syndrome undergoing
invasive management, radial as compared with femoral access reduces net
adverse clinical events, through a reduction in major bleeding and
all-cause mortality. Funding The Medicines Company and
Terumo.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<107>
Accession Number
602990849
Title
5-year outcomes of transcatheter aortic valve replacement compared with
standard treatment for patients with inoperable aortic stenosis (PARTNER
1): A randomised controlled trial.
Source
The Lancet. 385 (9986) (pp 2485-2491), 2015. Date of Publication: 20 Jun
2015.
Author
Kapadia S.R.; Leon M.B.; Makkar R.R.; Tuzcu E.M.; Svensson L.G.; Kodali
S.; Webb J.G.; Mack M.J.; Douglas P.S.; Thourani V.H.; Babaliaros V.C.;
Herrmann H.C.; Szeto W.Y.; Pichard A.D.; Williams M.R.; Fontana G.P.;
Miller D.C.; Anderson W.N.; Smith C.R.; Akin J.J.; Davidson M.J.
Institution
(Kapadia, Tuzcu, Svensson) Cleveland Clinic, Cleveland, OH, United States
(Leon, Kodali, Smith) Columbia University Medical Center, New York
Presbyterian Hospital, New York, NY, United States
(Makkar, Webb) Cedars Sinai Medical Center, Los Angeles, CA, United States
(Mack) St Paul's Hospital, Vancouver, BC, Canada
(Douglas) Baylor Scott and White Health, Plano, TX, United States
(Thourani, Babaliaros) Duke Clinical Research Institute, Duke University
Medical Center, Durham, NC, United States
(Herrmann, Szeto) Emory University, School of Medicine, Atlanta, GA,
United States
(Pichard) University of Pennsylvania, Philadelphia, PA, United States
(Williams) Medstar Washington Hospital Center, Washington, DC, United
States
(Fontana) NYU Langone Medical Center, New York, NY, United States
(Miller) Lenox Hill Hospital, New York, NY, United States
(Anderson) Stanford University School of Medicine, Falk CV Research
Center, Department of Cardiovascular Surgery, Stanford, CA, United States
(Anderson) Independent Consultant, Lake Forest, CA, United States
Publisher
Lancet Publishing Group
Abstract
Summary Background Based on the early results of the Placement of Aortic
Transcatheter Valves (PARTNER) trial, transcatheter aortic valve
replacement (TAVR) is an accepted treatment for patients with severe
aortic stenosis who are not suitable for surgery. However, little
information is available about the late clinical outcomes in such
patients. Methods We did this randomised controlled trial at 21
experienced valve centres in Canada, Germany, and the USA. We enrolled
patients with severe symptomatic inoperable aortic stenosis and randomly
assigned (1:1) them to transfemoral TAVR or to standard treatment, which
often included balloon aortic valvuloplasty. Patients and their treating
physicians were not masked to treatment allocation. The randomisation was
done centrally, and sites learned of the assignment only after a patient
had been screened, consented, and entered into the database. The primary
outcome of the trial was all-cause mortality at 1 year in the
intention-to-treat population, here we present the prespecified findings
after 5 years. This study is registered with ClinicalTrials.gov, number
NCT00530894. Findings We screened 3015 patients, of whom 358 were enrolled
(mean age 83 years, Society of Thoracic Surgeons Predicted Risk of
Mortality 11.7%, 54% female). 179 were assigned to TAVR treatment and 179
were assigned to standard treatment. 20 patients crossed over from the
standard treatment group and ten withdrew from study, leaving only six
patients at 5 years, of whom five had aortic valve replacement treatment
outside of the study. The risk of all-cause mortality at 5 years was 71.8%
in the TAVR group versus 93.6% in the standard treatment group (hazard
ratio 0.50, 95% CI 0.39-0.65; p<0.0001). At 5 years, 42 (86%) of 49
survivors in the TAVR group had New York Heart Association class 1 or 2
symptoms compared with three (60%) of five in the standard treatment
group. Echocardiography after TAVR showed durable haemodynamic benefit
(aortic valve area 1.52 cm² at 5 years, mean gradient 10.6 mm
Hg at 5 years), with no evidence of structural valve deterioration.
Interpretation TAVR is more beneficial than standard treatment for
treatment of inoperable aortic stenosis. TAVR should be strongly
considered for patients who are not surgical candidates for aortic valve
replacement to improve their survival and functional status. Appropriate
selection of patients will help to maximise the benefit of TAVR and reduce
mortality from severe comorbidities. Funding Edwards
Lifesciences.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<108>
Accession Number
602990835
Title
5-year outcomes of transcatheter aortic valve replacement or surgical
aortic valve replacement for high surgical risk patients with aortic
stenosis (PARTNER 1): A randomised controlled trial.
Source
The Lancet. 385 (9986) (pp 2477-2484), 2015. Date of Publication: 20 Jun
2015.
Author
Mack M.J.; Leon M.B.; Smith C.R.; Miller D.C.; Moses J.W.; Tuzcu E.M.;
Webb J.G.; Douglas P.S.; Anderson W.N.; Blackstone E.H.; Kodali S.K.;
Makkar R.R.; Fontana G.P.; Kapadia S.; Bavaria J.; Hahn R.T.; Thourani
V.H.; Babaliaros V.; Pichard A.; Herrmann H.C.; Brown D.L.; Williams M.;
Davidson M.J.; Svensson L.G.; Akin J.
Institution
(Mack, Kapadia) Baylor Scott and White Health, Plano, TX, United States
(Leon, Smith, Moses, Kodali, Hahn) Columbia University Medical Center, New
York Presbyterian Hospital, New York, NY, United States
(Miller) Stanford University School of Medicine, Falk CV Research Center,
Department of Cardiovascular Surgery, Stanford, CA, United States
(Tuzcu, Blackstone, Kapadia, Svensson) Cleveland Clinic, Cleveland, OH,
United States
(Webb) St Paul's Hospital, Vancouver, BC, Canada
(Douglas) Duke Clinical Research Institute, Duke University Medical
Center, Durham, NC, United States
(Makkar) Cedars Sinai Medical Center, Los Angeles, CA, United States
(Fontana) Lenox Hill Hospital, New York, NY, United States
(Bavaria) University of Pennsylvania, Philadelphia, PA, United States
(Herrmann) Emory University School of Medicine, Atlanta, GA, United States
(Thourani, Babaliaros) Medstar Washington Hospital Center, Washington, DC,
United States
(Pichard) Heart Hospital, Plano, TX, United States
(Brown) NYU Langone Medical Center, New York, NY, United States
(Williams) Brigham and Women's Hospital, Boston, MA, United States
(Anderson, Davidson) Independent Consultant, Lake Forest, CA, United
States
Publisher
Lancet Publishing Group
Abstract
Summary Background The Placement of Aortic Transcatheter Valves (PARTNER)
trial showed that mortality at 1 year, 2 years, and 3 years is much the
same with transcatheter aortic valve replacement (TAVR) or surgical aortic
valve replacement (SAVR) for high-risk patients with aortic stenosis. We
report here the 5-year outcomes. Methods We did this randomised controlled
trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23).
We used a computer-generated randomisation sequence to randomly assign
high-risk patients with severe aortic stenosis to either SAVR or TAVR with
a balloon-expandable bovine pericardial tissue valve by either a
transfemoral or transapical approach. Patients and their treating
physicians were not masked to treatment allocation. The primary outcome of
the trial was all-cause mortality in the intention-to-treat population at
1 year, we present here predefined outcomes at 5 years. The study is
registered with ClinicalTrials.gov, number NCT00530894. Findings We
screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR,
351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted
Risk of Mortality score was 11.7%. At 5 years, risk of death was 67.8% in
the TAVR group compared with 62.4% in the SAVR group (hazard ratio 1.04,
95% CI 0.86-1.24; p=0.76). We recorded no structural valve deterioration
requiring surgical valve replacement in either group. Moderate or severe
aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR
group and two (1%) of 228 in the SAVR group (p<0.0001), and was associated
with increased 5-year risk of mortality in the TAVR group (72.4% for
moderate or severe aortic regurgitation vs 56.6% for those with mild
aortic regurgitation or less; p=0.003). Interpretation Our findings show
that TAVR as an alternative to surgery for patients with high surgical
risk results in similar clinical outcomes. Funding Edwards
Lifesciences.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<109>
Accession Number
602903197
Title
Heart failure and mortality outcomes in patients with type 2 diabetes
taking alogliptin versus placebo in EXAMINE: A multicentre, randomised,
double-blind trial.
Source
The Lancet. 385 (9982) (pp 2067-2076), 2015. Date of Publication: 23 May
2015.
Author
Zannad F.; Cannon C.P.; Cushman W.C.; Bakris G.L.; Menon V.; Perez A.T.;
Fleck P.R.; Mehta C.R.; Kupfer S.; Wilson C.; Lam H.; White W.B.
Institution
(Zannad) Institut Lorrain du Coeur et des Vaisseaux, Universite de
Lorraine and CHU, Centre d'Investigation Clinique Inserm,
Vandoeuvre-Les-Nancy, France
(Cannon) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
(Cushman) University of Tennessee, College of Medicine, Memphis Veterans
Affairs Medical Center, Memphis, TN, United States
(Bakris) University of Chicago Pritzker School of Medicine, Chicago, IL,
United States
(Menon) Cleveland Clinic Foundation, Cleveland, OH, United States
(Perez, Fleck, Kupfer, Wilson, Lam) Takeda Development Center Americas,
Deerfield, IL, United States
(Mehta) Harvard School of Public Health, Boston, MA, United States
(White) Calhoun Cardiology Center, University of Connecticut School of
Medicine, Farmington, CT, United States
Publisher
Lancet Publishing Group
Abstract
Background The EXAMINE trial showed non-inferiority of the DPP-4 inhibitor
alogliptin to placebo on major adverse cardiac event (MACE) rates in
patients with type 2 diabetes and recent acute coronary syndromes.
Concerns about excessive rates of in-hospital heart failure in another
DPP-4 inhibitor trial have been reported. We therefore assessed hospital
admission for heart failure in the EXAMINE trial. Methods Patients with
type 2 diabetes and an acute coronary syndrome event in the previous 15-90
days were randomly assigned alogliptin or placebo plus standard treatment
for diabetes and cardiovascular disease prevention. The prespecified
exploratory extended MACE endpoint was all-cause mortality, non-fatal
myocardial infarction, non-fatal stroke, urgent revascularisation due to
unstable angina, and hospital admission for heart failure. The post-hoc
analyses were of cardiovascular death and hospital admission for heart
failure, assessed by history of heart failure and brain natriuretic
peptide (BNP) concentration at baseline. We also assessed changes in
N-terminal pro-BNP (NT-pro-BNP) from baseline to 6 months. This study is
registered with ClinicalTrials.gov, number NCT00968708. Findings 5380
patients were assigned to alogliptin (n=2701) or placebo (n=2679) and
followed up for a median of 533 days (IQR 280-751). The exploratory
extended MACE endpoint was seen in 433 (16.0%) patients assigned to
alogliptin and in 441 (16.5%) assigned to placebo (hazard ratio [HR] 0.98,
95% CI 0.86-1.12). Hospital admission for heart failure was the first
event in 85 (3.1%) patients taking alogliptin compared with 79 (2.9%)
taking placebo (HR 1.07, 95% CI 0.79-1.46). Alogliptin had no effect on
composite events of cardiovascular death and hospital admission for heart
failure in the post hoc analysis (HR 1.00, 95% CI 0.82-1.21) and results
did not differ by baseline BNP concentration. NT-pro-BNP concentrations
decreased significantly and similarly in the two groups. Interpretation In
patients with type 2 diabetes and recent acute coronary syndromes,
alogliptin did not increase the risk of heart failure outcomes. Funding
Takeda Development Center Americas.<br/>Copyright &#xa9; 2015 Elsevier
Ltd.

<110>
Accession Number
605281373
Title
Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED
II): A prospective, open-label, multicentre, randomised non-inferiority
trial.
Source
The Lancet. 385 (9987) (pp 2577-2584), 2015. Date of Publication: 27 Jun
2015.
Author
Ardehali A.; Esmailian F.; Deng M.; Soltesz E.; Hsich E.; Naka Y.; Mancini
D.; Camacho M.; Zucker M.; Leprince P.; Padera R.; Kobashigawa J.
Institution
(Ardehali, Deng) UCLA Medical Center, Division of Cardiac Surgery, Los
Angeles, CA 90049, United States
(Esmailian, Kobashigawa) Cedars-Sinai Heart Institute, Los Angeles, CA,
United States
(Soltesz, Hsich) Cleveland Clinic Foundation, Cleveland, OH, United States
(Naka, Mancini) Columbia University Medical Center, New York, NY, United
States
(Camacho, Zucker) St Barnabas Heart Center, Newark Beth Israel Medical
Center, Newark, NJ, United States
(Leprince) Hopital de la Pitie-Salpetriere, Paris, France
(Padera) Brigham and Women's Hospital, Boston, MA, United States
Publisher
Lancet Publishing Group
Abstract
Background The Organ Care System is the only clinical platform for ex-vivo
perfusion of human donor hearts. The system preserves the donor heart in a
warm beating state during transport from the donor hospital to the
recipient hospital. We aimed to assess the clinical outcomes of the Organ
Care System compared with standard cold storage of human donor hearts for
transplantation. Methods We did this prospective, open-label, multicentre,
randomised non-inferiority trial at ten heart-transplant centres in the
USA and Europe. Eligible heart-transplant candidates (aged >18 years) were
randomly assigned (1:1) to receive donor hearts preserved with either the
Organ Care System or standard cold storage. Participants, investigators,
and medical staff were not masked to group assignment. The primary
endpoint was 30 day patient and graft survival, with a 10% non-inferiority
margin. We did analyses in the intention-to-treat, as-treated, and
per-protocol populations. This trial is registered with
ClinicalTrials.gov, number NCT00855712. Findings Between June 29, 2010,
and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care
System group (n=67) or the standard cold storage group (n=63). 30 day
patient and graft survival rates were 94% (n=63) in the Organ Care System
group and 97% (n=61) in the standard cold storage group (difference 2.8%,
one-sided 95% upper confidence bound 8.8; p=0.45). Eight (13%) patients in
the Organ Care System group and nine (14%) patients in the standard cold
storage group had cardiac-related serious adverse events. Interpretation
Heart transplantation using donor hearts adequately preserved with the
Organ Care System or with standard cold storage yield similar short-term
clinical outcomes. The metabolic assessment capability of the Organ Care
System needs further study. Funding TransMedics.<br/>Copyright &#xa9; 2015
Elsevier Ltd.

<111>
Accession Number
601554983
Title
Efficacy and safety of LDL-lowering therapy among men and women:
Meta-analysis of individual data from 174 000 participants in 27
randomised trials.
Source
The Lancet. 385 (9976) (pp 1397-1405), 2015. Date of Publication: 01 Jan
2015.
Author
Fulcher J.; O'Connell R.; Voysey M.; Emberson J.; Blackwell L.; Mihaylova
B.; Simes J.; Collins R.; Kirby A.; Colhoun H.; Braunwald E.; La Rosa J.;
Pedersen T.R.; Tonkin A.; Davis B.; Sleight P.; Franzosi M.G.; Baigent C.;
Keech A.; De Lemos J.; Blazing M.; Murphy S.; Downs J.R.; Gotto A.;
Clearfield M.; Holdaas H.; Gordon D.; Koren M.; Dahlof B.; Poulter N.;
Sever P.; Knopp R.H.; Fellstrom B.; Jardine A.; Schmieder R.; Zannad F.;
Goldbourt U.; Kaplinsky E.; Betteridge D.J.; Durrington P.N.; Hitman G.A.;
Fuller J.; Neil A.; Wanner C.; Krane V.; Sacks F.; Moye L.; Pfeffer M.;
Hawkins C.M.; Kjekshus J.; Wedel H.; Wikstrand J.; Barter P.; Tavazzi L.;
Maggioni A.; Marchioli R.; Tognoni G.; Bloomfield H.; Robins S.; Armitage
J.; Parish S.; Peto R.; Ridker P.M.; Holman R.; Meade T.; MacMahon S.;
Marschner I.; Shaw J.; Serruys P.W.; Nakamura H.; Knatterud G.; Furberg
C.; Byington R.; Macfarlane P.; Ford I.; Murphy M.; Marschner I.C.; Blauw
G.J.; Packard C.; Shepherd J.; Wilhelmsen L.; Cannon C.; Bowman L.;
Landray M.; Rossouw J.; Probstfield J.; Cobbe S.; Flather M.; Kastelein
J.; Newman C.; Shear C.; Tobert J.; Varigos J.; White H.; Yusuf S.; Barnes
E.H.; Herrington W.G.; Holland L.E.; Reith C.
Institution
(Simes, Kirby, Keech, Marschner, Barnes) CTC, University of Sydney,
Australia
(Emberson, Blackwell, Mihaylova, Collins, Baigent, Herrington, Holland,
Reith) CTSU, University of Oxford, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background: Whether statin therapy is as effective in women as in men is
debated, especially for primary prevention. We undertook a meta-analysis
of statin trials in the Cholesterol Treatment Trialists' (CTT)
Collaboration database to compare the effects of statin therapy between
women and men. <br/>Method(s): We performed meta-analyses on data from 22
trials of statin therapy versus control (n=134 537) and five trials of
more-intensive versus less-intensive statin therapy (n=39 612). Effects on
major vascular events, major coronary events, stroke, coronary
revascularisation and mortality were weighted per 1.0 mmol/L reduction in
LDL cholesterol and effects in men and women compared with a Cox model
that adjusted for non-sex differences. For subgroup analyses, we used 99%
CIs to make allowance for the multiplicity of comparisons. Findings 46 675
(27%) of 174 149 randomly assigned participants were women. Allocation to
a statin had similar absolute effects on 1 year lipid concentrations in
both men and women (LDL cholesterol reduced by about 1.1 mmol/L in statin
vs control trials and roughly 0.5 mmol/L for more-intensive vs
less-intensive therapy). Women were generally at lower cardiovascular risk
than were men in these trials. The proportional reductions per 1.0 mmol/L
reduction in LDL cholesterol in major vascular events were similar overall
for women (rate ratio [RR] 0.84, 99% CI 0.78-0.91) and men (RR 0.78, 99%
CI 0.75-0.81, adjusted p value for heterogeneity by sex=0.33) and also for
those women and men at less than 10% predicted 5 year absolute
cardiovascular risk (adjusted heterogeneity p=0.11). Likewise, the
proportional reductions in major coronary events, coronary
revascularisation, and stroke did not differ significantly by sex. No
adverse effect on rates of cancer incidence or non-cardiovascular
mortality was noted for either sex. These net benefits translated into
all-cause mortality reductions with statin therapy for both women (RR
0.91, 99% CI 0.84-0.99) and men (RR 0.90, 99% CI 0.86-0.95; adjusted
heterogeneity p=0.43). Interpretation In men and women at an equivalent
risk of cardiovascular disease, statin therapy is of similar effectiveness
for the prevention of major vascular events.

<112>
Accession Number
604965368
Title
Bronchoscopic lung volume reduction with endobronchial valves for patients
with heterogeneous emphysema and intact interlobar fissures (the
BeLieVeR-HIFi study): A randomised controlled trial.
Source
The Lancet. 386 (9998) (pp 1066-1073), 2015. Date of Publication: 12 Sep
2015.
Author
Davey C.; Zoumot Z.; Jordan S.; McNulty W.H.; Carr D.H.; Hind M.D.;
Hansell D.M.; Rubens M.B.; Banya W.; Polkey M.I.; Shah P.L.; Hopkinson
N.S.
Institution
(Davey, Zoumot, Jordan, McNulty, Carr, Hind, Hansell, Rubens, Banya,
Polkey, Shah, Hopkinson) NIHR Respiratory Disease, Biomedical Research
Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College
London, London, United Kingdom
Publisher
Lancet Publishing Group
Abstract
Background Lung volume reduction surgery improves survival in selected
patients with emphysema, and has generated interest in bronchoscopic
approaches that might achieve the same effect with less morbidity and
mortality. Previous trials with endobronchial valves have yielded modest
group benefits because when collateral ventilation is present it prevents
lobar atelectasis. Methods We did a single-centre, double-blind
sham-controlled trial in patients with both heterogeneous emphysema and a
target lobe with intact interlobar fissures on CT of the thorax. We
enrolled stable outpatients with chronic obstructive pulmonary disease who
had a forced expiratory volume in 1 s (FEV<inf>1</inf>) of less than 50%
predicted, significant hyperinflation (total lung capacity >100% and
residual volume >150%), a restricted exercise capacity (6 min walking
distance <450 m), and substantial breathlessness (MRC dyspnoea score 3).
Participants were randomised (1:1) by computer-generated sequence to
receive either valves placed to achieve unilateral lobar occlusion
(bronchoscopic lung volume reduction) or a bronchoscopy with sham valve
placement (control). Patients and researchers were masked to treatment
allocation. The study was powered to detect a 15% improvement in the
primary endpoint, the FEV<inf>1</inf> 3 months after the procedure.
Analysis was on an intention-to-treat basis. The trial is registered at
controlled-trials.com, ISRCTN04761234. Findings 50 patients (62% male,
FEV<inf>1</inf> [% predicted] mean 31.7% [SD 10.2]) were enrolled to
receive valves (n=25) or sham valve placement (control, n=25) between
March 1, 2012, and Sept 30, 2013. In the bronchoscopic lung volume
reduction group, FEV<inf>1</inf> increased by a median 8.77% (IQR
2.27-35.85) versus 2.88% (0-8.51) in the control group (Mann-Whitney
p=0.0326). There were two deaths in the bronchoscopic lung volume
reduction group and one control patient was unable to attend for follow-up
assessment because of a prolonged pneumothorax. Interpretation Unilateral
lobar occlusion with endobronchial valves in patients with heterogeneous
emphysema and intact interlobar fissures produces significant improvements
in lung function. There is a risk of significant complications and further
trials are needed that compare valve placement with lung volume reduction
surgery. Funding Efficacy and Mechanism Evaluation Programme, funded by
the Medical Research Council (MRC) and managed by the National Institute
for Health Research (NIHR) on behalf of the MRC-NIHR
partnership.<br/>Copyright &#xa9; 2015 Elsevier Ltd.

<113>
Accession Number
608383546
Title
Prognosis following acute coronary syndromes according to prior coronary
artery bypass grafting: Meta-analysis.
Source
European Heart Journal: Acute Cardiovascular Care. 4 (6) (pp 518-527),
2015. Date of Publication: December 2015.
Author
Teixeira R.; Vieira M.J.; Ribeiro M.A.; Goncalves L.; Gersh B.J.
Institution
(Teixeira, Ribeiro) Departamento de Medicina, Servico de Cardiologia,
Hospital Beatriz Angelo, Loures, Portugal
(Teixeira, Vieira, Goncalves) Universidade de Coimbra, Coimbra, Portugal
(Goncalves) Servico de Cardiologia, Centro Hospitalar e Universitario de
Coimbra, Hospital Geral, Coimbra, Portugal
(Gersh) Division of Cardiovascular Disease and Internal Medicine, Mayo
Clinic, Rochester, United States
Publisher
SAGE Publications Inc.
Abstract
Purpose: Conduct a meta-analysis to study the prognostic influence of a
previous coronary artery bypass grafting (CABG) in patients admitted for
an acute coronary syndrome (ACS). <br/>Method(s): A systematic review of
the literature was performed using electronic reference databases through
January 2013 (MEDLINE, Cochrane Library, Web of Knowledge, Google Scholar
and references cited in other studies). Studies in which ACS outcomes with
a previous history of CABG were compared with ACS outcomes with no history
of previous CABG were considered for inclusion. The main endpoints of
interest were mortality and non-fatal acute myocardial infarction. Data
was aggregated at three follow-up times using random-effects meta-analysis
models. <br/>Result(s): Twenty-four studies were included which provided
387,181 patients for analysis. Previous CABG ACS patients were older, more
diabetic and had a more frequent history of a previous myocardial
infarction. Pooled in-hospital mortality was higher for the previous CABG
ACS patients (OR 1.22 [1.04-1.44], p<0.01, I² 88%). The pooled
adjusted OR showed no significant differences for the two groups (adjusted
OR 1.13 [0.93-1.37], p=0.22, I² 92%). Previous CABG ACS patient
had a higher pooled 30-day mortality (OR 1.28 [1.05-1.55], p=0.02,
I² 74%); a higher non-adjusted (OR 1.61 [1.38-1.88], p<0.01,
I² 70%) and adjusted (adjusted OR 1.37 [1.15-1.65], p<0.01,
I² 0%) long-term mortality. Both the in-hospital and the
long-term re-infarction rates were higher for the previous CABG ACS
patients. <br/>Conclusion(s): According to our data, ACS patients with
previous CABG history had a higher risk for short- and longterm adverse
events.<br/>Copyright &#xa9; The European Society of Cardiology 2014.

<114>
Accession Number
600767570
Title
Ultrathin strut biodegradable polymer sirolimus-eluting stent versus
durable polymer everolimus-eluting stent for percutaneous coronary
revascularisation (BIOSCIENCE): A randomised, single-blind,
non-inferiority trial.
Source
The Lancet. 384 (9960) (pp 2111-2122), 2014. Date of Publication: 13 Dec
2014.
Author
Pilgrim T.; Heg D.; Roffi M.; Tuller D.; Muller O.; Vuilliomenet A.; Cook
S.; Weilenmann D.; Kaiser C.; Jamshidi P.; Fahrni T.; Moschovitis A.;
Noble S.; Eberli F.R.; Wenaweser P.; Juni P.; Windecker S.
Institution
(Pilgrim, Fahrni, Moschovitis, Wenaweser, Windecker) Department of
Cardiology, Swiss Cardiovascular Center, University Hospital, Bern 3010,
Switzerland
(Roffi, Noble) Department of Cardiology, University Hospital, Geneva,
Switzerland
(Tuller, Eberli) Department of Cardiology, Triemlispital, Zurich,
Switzerland
(Muller) Department of Cardiology, University Hospital, Lausanne,
Switzerland
(Vuilliomenet) Department of Cardiology, Kantonsspital, Aarau, Switzerland
(Cook) Department of Cardiology, University Hospital, Fribourg,
Switzerland
(Weilenmann) Department of Cardiology, Kantonsspital, St Gallen,
Switzerland
(Kaiser) Department of Cardiology, University Hospital, Basel, Switzerland
(Jamshidi) Department of Cardiology, Kantonsspital, Luzern, Switzerland
(Heg, Juni) Institute of Social and Preventive Medicine, Clinical Trials
Unit, Bern University Hospital, Bern, Switzerland
Publisher
Lancet Publishing Group
Abstract
Background Refinements in stent design affecting strut thickness, surface
polymer, and drug release have improved clinical outcomes of drug-eluting
stents. We aimed to compare the safety and efficacy of a novel, ultrathin
strut cobalt-chromium stent releasing sirolimus from a biodegradable
polymer with a thin strut durable polymer everolimus-eluting stent.
Methods We did a randomised, single-blind, non-inferiority trial with
minimum exclusion criteria at nine hospitals in Switzerland. We randomly
assigned (1:1) patients aged 18 years or older with chronic stable
coronary artery disease or acute coronary syndromes undergoing
percutaneous coronary intervention to treatment with biodegradable polymer
sirolimus-eluting stents or durable polymer everolimus-eluting stents.
Randomisation was via a central web-based system and stratified by centre
and presence of ST segment elevation myocardial infarction. Patients and
outcome assessors were masked to treatment allocation, but treating
physicians were not. The primary endpoint, target lesion failure, was a
composite of cardiac death, target vessel myocardial infarction, and
clinically-indicated target lesion revascularisation at 12 months. A
margin of 3.5% was defined for non-inferiority of the biodegradable
polymer sirolimus-eluting stent compared with the durable polymer
everolimus-eluting stent. Analysis was by intention to treat. The trial is
registered with ClinicalTrials.gov, number NCT01443104.
Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119
patients with 3139 lesions to treatment with sirolimus-eluting stents
(1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients,
1545 lesions). 407 (19%) patients presented with ST-segment elevation
myocardial infarction. Target lesion failure with biodegradable polymer
sirolimus-eluting stents (69 cases; 6.5%) was non-inferior to durable
polymer everolimus-eluting stents (70 cases; 6.6%) at 12 months (absolute
risk difference -0.14%, upper limit of one-sided 95% CI 1.97%, p for
non-inferiority <0.0004). No significant differences were noted in rates
of definite stent thrombosis (9 [0.9%] vs 4 [0.4%], rate ratio [RR] 2.26,
95% CI 0.70-7.33, p=0.16). In pre-specified stratified analyses of the
primary endpoint, biodegradable polymer sirolimus-eluting stents were
associated with improved outcome compared with durable polymer
everolimus-eluting stents in the subgroup of patients with ST-segment
elevation myocardial infarction (7 [3.3%] vs 17 [8.7%], RR 0.38, 95% CI
0.16-0.91, p=0.024, p for interaction=0.014).
Interpretation In a patient population with minimum exclusion criteria and
high adherence to dual antiplatelet therapy, biodegradable polymer
sirolimus-eluting stents were non-inferior to durable polymer
everolimus-eluting stents for the combined safety and efficacy outcome
target lesion failure at 12 months. The noted benefit in the subgroup of
patients with ST-segment elevation myocardial infarction needs further
study.
Funding Clinical Trials Unit, University of Bern, and Biotronik, Bulach,
Switzerland.<br/>Copyright &#xa9; 2014 Elsevier Ltd.

<115>
Accession Number
2007145670
Title
Sensitivity of lung ultrasound for the detection of pneumothorax one day
after pulmonary resection-a prospective observational study.
Source
European Surgery - Acta Chirurgica Austriaca. 53 (1) (pp 23-28), 2021.
Date of Publication: February 2021.
Author
Galetin T.; Schieren M.; Marks B.; Defosse J.; Stoelben E.
Institution
(Galetin, Stoelben) Lung Clinic, Thoracic Surgery, Medical Centre
Cologne-Merheim, University Witten/Herdecke, Ostmerheimer Str. 200,
Cologne 51109, Germany
(Schieren, Defosse) Department of Anaesthesiology and Intensive Care
Medicine, Medical Centre Cologne-Merheim, University Witten/Herdecke,
Cologne, Germany
(Marks) Department of Radiology, Medical Centre Cologne-Merheim,
University Witten/Herdecke, Cologne, Germany
Publisher
Springer
Abstract
Background: Chest X-ray (CXR) after thoracic surgery contributes to
patient discomfort and costs and is of limited therapeutic value. Lung
ultrasound (LU) for pneumothorax may be an alternative to CXR, but
diagnostic accuracy data are heterogeneous and biased by insufficient
sonographic technique and patient selection. Reported sensitivities range
from 0.21 to 1.0. We evaluated the sensitivity of LU on the first day
after thoracic surgery under routine conditions. <br/>Method(s): We
performed a prospective observational study (trial-ID DRKS00014557).
Consecutive patients undergoing lung resection received standardized LU in
addition to routine CXR on the first postoperative day. Ultrasound
examiner and radiologist were blinded to corresponding X-ray and
ultrasound findings. CXR was used as reference to determine diagnostic
test performance of ultrasound. The conformity of sonography- and
routine-based therapeutic decisions was evaluated. <br/>Result(s): A total
of 68 patients were examined. The mean duration of ultrasound was 145+/-
64s. CXR identified 23 patients with pneumothorax with a mean
apex-to-cupola size of 1.5+/- 1.0cm. Ultrasound detected 18 patients with
pneumothorax. The computed sensitivity of LU was 0.48 (95% confidence
interval [0.36; 0.60]). Specificity was between 0.81 and 1.0, the negative
predictive value 0.76 [0.66; 0.86]. The sensitivity of CXR was 0.56 [0.44;
0.68]. Air leakage via chest tube correlated weakly with CXR (spearman's
rho= 0.26) and moderately with LU (rho= 0.43). The conformity between
sonographically based recommendations and the actual therapy based on
routine diagnostics was 96%. <br/>Conclusion(s): Sensitivity of ultrasound
for pneumothorax detection nearly reached CXR and resulted in equally safe
patient management. Our data can serve as a pilot study for upcoming
larger-scaled controlled trials.<br/>Copyright &#xa9; 2020, The Author(s).

<116>
Accession Number
2007982893
Title
Postoperative Atrial Fibrillation After Cardiac Surgery: A Systematic
Review and Meta-Analysis.
Source
Annals of Thoracic Surgery. 111 (2) (pp 544-554), 2021. Date of
Publication: February 2021.
Author
Eikelboom R.; Sanjanwala R.; Le M.-L.; Yamashita M.H.; Arora R.C.
Institution
(Eikelboom, Yamashita, Arora) Max Rady College of Medicine, University of
Manitoba, Winnipeg, Canada
(Sanjanwala, Yamashita, Arora) Cardiac Sciences Program, St. Boniface
Hospital, Winnipeg, MB, Canada
(Le) Libraries, University of Manitoba, Winnipeg, MB, Canada
(Yamashita, Arora) Institute of Cardiovascular Sciences, St. Boniface
Hospital Research Centre, Winnipeg, MB, Canada
Publisher
Elsevier Inc.
Abstract
Background: Postoperative atrial fibrillation (POAF) after cardiac surgery
is associated with longer hospital stay and increased in-hospital death
and stroke, but its long-term implications remain incompletely understood.
A systematic literature review was undertaken to investigate the impact of
POAF on long-term death and stroke in adult patients who undergo cardiac
operations. <br/>Method(s): Electronic databases (Cochrane, Embase, Ovid
MEDLINE, and PubMed) were queried from inception to October 2018. Included
studies compared long-term outcomes after cardiac operations in patients
with and without POAF. Adjusted and unadjusted meta-analyses examined
death, stroke, and major adverse cardiac and cerebrovascular events. Risk
of bias was evaluated with the Newcastle-Ottawa Scale. <br/>Result(s): The
inclusion criteria were met by 32 studies describing 155,575 patients who
had undergone cardiac operations. POAF occurred in 36,988 patients
(23.7%). Meta-analysis of 10 studies (44,367 patients) demonstrated
increased 1-year death in patients with POAF (odds ratio, 2.60; 95%
confidence interval, 2-3.38; P <.01). Aggregate adjusted hazard of death
(16 studies, n = 84,295) was also increased in patients with POAF (hazard
ratio, 1.25; 95% confidence interval, 1.2-1.3; P <.01).
<br/>Conclusion(s): This systematic review and meta-analysis identified an
association between POAF and long-term death after cardiac surgery. More
comprehensive POAF prevention and management, including more stringent
follow-up for POAF recurrence after hospital discharge, may be indicated.
The included studies used inconsistent definitions of POAF and variable
exclusion criteria; however, estimates of heterogeneity are low.
Differences in preoperative comorbidities, such as age, ejection fraction,
and obesity, may not be fully accounted for in adjusted analyses. Future
work is required to delineate mechanisms linking POAF and death in this
population.<br/>Copyright &#xa9; 2021 The Society of Thoracic Surgeons

<117>
Accession Number
2007611988
Title
A physician survey of perioperative neuraxial anesthesia management in
patients on a direct oral anticoagulant.
Source
Research and Practice in Thrombosis and Haemostasis. 5 (1) (pp 159-167),
2021. Date of Publication: January 2021.
Author
Douketis J.D.; Syed S.; Li N.; Narouze S.; Radwi M.; Duncan J.; Schulman
S.; Spyropoulos A.C.
Institution
(Douketis, Li, Duncan, Schulman) Department of Medicine, McMaster
University, Hamilton, ON, Canada
(Syed) Department of Anesthesiology, McMaster University, Hamilton, ON,
Canada
(Narouze) Center for Pain Medicine, Western Reserve Hospital, Cuyahoga
Falls, OH, United States
(Radwi) Department of Hematology, Faculty of Medicine, University of
Jeddah, Jeddah, Saudi Arabia
(Schulman) Department of Obstetrics and Gynecology, I.M. Sechenov First
Moscow State Medical University, Moscow, Russian Federation
(Spyropoulos) Zucker School of Medicine at Hofstra/Northwell, Northwell
Health at Lenox Hill Hospital, New York, NY, United States
Publisher
Blackwell Publishing Ltd
Abstract
Background: The perioperative management of patients taking a direct oral
anticoagulant (DOAC) who require a high-bleed-risk surgery and/or
neuraxial anesthesia is uncertain. We surveyed clinician practices
relating to DOAC interruption and related perioperative management in
patients having high-bleed-risk surgery with neuraxial anesthesia, and
assess the suitability of a randomized trial of different perioperative
DOAC management strategies. <br/>Method(s): We surveyed members of the
American Society of Regional Anesthesia and Pain Medicine, the Canadian
Anesthesia Society and Thrombosis Canada. We developed four clinical
scenarios involving DOAC-treated patients who required anticoagulant
interruption for elective high-bleed-risk surgery. In three scenarios,
patients were to receive neuraxial anesthesia, and in one scenario they
were to receive general anesthesia. We also asked about the merit of a
randomized trial to compare a 2-day versus longer (3- to 5-day) duration
of DOAC interruption. <br/>Result(s): There were 399 survey respondents of
whom 356 (89%) were anesthetists and 43 (11%) were medical specialists.
The responses indicate uncertainty about the DOAC interruption interval
for high-bleed-risk surgery and/or neuraxial anesthesia; anesthetists
favor 3- to 5-day interruption whereas medical specialists favor 2-day
interruption. Anesthetists were unwilling to proceed with neuraxial
anesthesia in patients with a 2-day DOAC interruption interval, preferring
to cancel the surgery or switch to general anesthesia. There is general
agreement on the need for a randomized trial in this field to compare a
2-day and a 3- to 5-day DOAC interruption management strategy.
<br/>Conclusion(s): There is variability in practices relating to the
perioperative management of DOAC-treated patients who require a
high-bleed-risk surgery with neuraxial anesthesia; this variability
relates to the duration of DOAC interruption in such
patients.<br/>Copyright &#xa9; 2020 The Authors. Research and Practice in
Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of
International Society on Thrombosis and Haemostasis (ISTH)

<118>
Accession Number
2005894506
Title
Therapeutic plasma exchange and intravenous immune globulin in the
treatment of heparin-induced thrombocytopenia: A systematic review.
Source
Transfusion. 60 (11) (pp 2714-2736), 2020. Date of Publication: November
2020.
Author
Onuoha C.; Barton K.D.; Wong E.C.C.; Raval J.S.; Rollins-Raval M.A.; Ipe
T.S.; Kiss J.E.; Boral L.I.; Adamksi J.; Zantek N.D.; Onwuemene O.A.
Institution
(Onuoha) Department of Pediatrics, East Carolina University, Vidant
Medical Center, Greenville, NC, United States
(Barton) Medical Center Library, Duke University Medical Center, Durham,
NC, United States
(Wong) Department of Pediatrics and Pathology, George Washington School of
Medicine and Health Sciences, Washington, DC, United States
(Wong) Department of Coagulation, Quest Diagnostics, Nichols Institute,
Centreville, VA, United States
(Raval, Rollins-Raval) Department of Pathology, University of New Mexico,
Albuquerque, NM, United States
(Ipe) Department of Pathology and Laboratory Medicine, University of
Arkansas for Medical Sciences, Little Rock, AR, United States
(Kiss) Department of Medicine, Vitalant Northeast Division and The
University of Pittsburgh, Pittsburgh, PA, United States
(Boral) Department of Pathology and Laboratory Medicine, University of
Kentucky Health Care, Lexington, KY, United States
(Adamksi) Department of Laboratory Medicine and Pathology, Mayo Clinic
Arizona, Phoenix, AZ, United States
(Zantek) Department of Laboratory Medicine and Pathology, University of
Minnesota, Minneapolis, MN, United States
(Onwuemene) Department of Medicine, Duke University School of Medicine,
Durham, NC, United States
Publisher
Blackwell Publishing Inc.
Abstract
Background: Immunomodulatory strategies in heparin-induced
thrombocytopenia (HIT) include the use of intravenous immune globulin
(IVIG) and therapeutic plasma exchange (TPE). The optimal application of
these therapies is unknown and outcomes data are limited. We investigated
treatment categories and laboratory and clinical outcomes of IVIG and/or
TPE in HIT with a systematic literature review. Study Design and Methods:
We searched MEDLINE, Embase, and Web of Science through December 2019 for
studies combining controlled vocabulary and keywords related to
thrombocytopenia, heparin, TPE, and IVIG. The primary outcome was
treatment indication. Secondary outcomes were platelet recovery, HIT
laboratory parameters, heparin re-exposure, and post-treatment course.
Case-level data were analyzed by qualitative synthesis. <br/>Result(s):
After 4241 references were screened, we identified 60 studies with four
main categories of IVIG and/or TPE use as follows: (a) treatment of
refractory HIT (n = 35; 31%); (b) initial therapy (n = 45; 40%); (c)
cardiopulmonary bypass surgery (CPB; n = 30; 27%); and (d) other (n = 2;
2%). IVIG was most commonly used for the treatment of refractory HIT while
TPE was primarily used to facilitate heparin exposure during CPB. Both
IVIG and TPE were equally used as initial therapy. Heparin re-exposure
occurred without thrombotic event in 29 TPE-treated patients and three
IVIG-treated patients. <br/>Conclusion(s): In patients with HIT, both TPE
and IVIG are used for initial therapy or treatment of refractory HIT.
However, TPE is more commonly used in patients undergoing CPB. Prospective
studies may help clarify which treatment is indicated in HIT population
subsets.<br/>Copyright &#xa9; 2020 AABB

<119>
Accession Number
2006161023
Title
Left Atrial or Transeptal Approach for Mitral Valve Surgery: A Systematic
Review and Meta-analysis.
Source
Current Problems in Cardiology. 46 (3) (no pagination), 2021. Article
Number: 100602. Date of Publication: March 2021.
Author
Harky A.; Kusu-Orkar T.-E.; Chan J.S.K.; Noshirwani A.; Savarimuthu S.;
Pousios D.; Muir A.D.
Institution
(Harky, Kusu-Orkar, Noshirwani, Pousios, Muir) Department of
cardiothoracic surgery, Liverpool Heart and Chest Hospital, Liverpool,
United Kingdom
(Harky) School of Medicine, University of Liverpool, Liverpool, United
Kingdom
(Chan) Division of Cardiology, Department of Medicine and Therapeutics,
Prince of Wales Hospital, Hong Kong
(Chan) Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong
(Savarimuthu) Department of cardiothoracic surgery, Barts Heart Centre,
St. Bartholomew's Hospital, London, United Kingdom
Publisher
Mosby Inc.
Abstract
To compare outcomes of mitral valve surgery through conventional left
atriotomy and transeptal approach (TS). Preferred Reporting Items for
Systematic Reviews and Meta-Analyses guidelines were followed. Primary
outcomes were operative mortality and permanent pacemaker (PPM)
implantation; secondary outcomes were new onset of atrial fibrillation
(AF), stroke and operative times. Sixteen articles met the inclusion
criteria with 4537 patients. Cardiopulmonary bypass was longer with TS
(weighted mean differences - 16.44 minutes [-29.53, -3.36], P = 0.01).
Rates of PPM implantation (risk ratio 0.65 [0.47, 0.89], P = 0.007) and
new onset AF (risk ratio 0.87 [0.78, 0.97], P = 0.02) were higher with TS.
Subgroup analysis of isolated mitral valve surgery cohort showed no
difference in operative times, mortality, new onset of AF, stroke, and PPM
implantation. There is equal outcomes between both approaches during
isolated mitral valve surgery; however, TS was associated with longer
operative times and higher postoperative AF and PPM rates when pooling
combined procedures. A large randomized controlled trial is required to
confirm those findings.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<120>
Accession Number
2006141430
Title
Evolution of Transcatheter Aortic Valve Replacement , Review of
Literature.
Source
Current Problems in Cardiology. 46 (3) (no pagination), 2021. Article
Number: 100600. Date of Publication: March 2021.
Author
Jiang T.; Hasan S.M.; Faluk M.; Patel J.
Publisher
Mosby Inc.
Abstract
Aortic valve stenosis is the most common primary valvular heart disease
leading to either surgical or transcatheter valve replacement in the
United States with its prevalence on the rise due to the elderly
population. Over the recent years, the rise of transcatheter aortic valve
replacement has been exponential due to technologic developments and
randomized control trials. In this review article, we aim to review
current literature on transcatheter aortic valve
replacements.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<121>
Accession Number
2006130020
Title
The efficacy of early postoperative enteral immunonutrition on
T-lymphocyte count: A randomised control study in low-risk cardiac surgery
patients.
Source
Clinical Nutrition. 40 (2) (pp 372-379), 2021. Date of Publication:
February 2021.
Author
Svetikiene M.; Ringaitiene D.; Vezeliene J.; Isajevas V.; Trybe D.; Vicka
V.; Malickaite R.; Jurgauskiene L.; Norkuniene J.; Serpytis M.; Sipylaite
J.
Institution
(Svetikiene, Ringaitiene, Isajevas, Serpytis, Sipylaite) Department of
Anaesthesiology and Intensive Care, Institute of Clinical Medicine,
Faculty of Medicine, Vilnius University, Lithuania
(Svetikiene, Ringaitiene, Vezeliene, Isajevas, Vicka, Serpytis, Sipylaite)
Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
(Trybe, Vicka) Faculty of Medicine, Vilnius University, Vilnius, Lithuania
(Malickaite, Jurgauskiene) Clinic of Cardiac and Vascular Diseases,
Institute of Clinical Medicine, Faculty of Medicine, Vilnius University,
Vilnius, Lithuania
(Norkuniene) Department of Mathematical Statistics, Faculty of Fundamental
Sciences, Vilnius Gediminas Technical University, Vilnius, Lithuania
Publisher
Churchill Livingstone
Abstract
Background: Patients undergoing cardiac surgery have a pronounced immune
response that leads to a reduction in cellular immunity. Immune-modulating
nutritional supplements are considered to be beneficial for patients
undergoing major surgery. However, due to the lack of studies in the
cardiac surgery population, the effect of immunonutrition remains unclear
in this patient group. <br/>Objective(s): Our purpose was to research the
efficacy of early postoperative enteral immunonutrition on T-lymphocyte
count in the cardiac surgery population. <br/>Method(s): This was a
randomised control study of low operative risk adult patients, who
underwent elective cardiac surgery. These patients were randomised into
immunonutrition and control groups. The immunonutrition group was
supplemented with immune nutrients for five postoperative days. The counts
of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell
subpopulations were determined on the day of surgery and on the sixth
postoperative day. <br/>Result(s): Fifty-five patients were enrolled in
the study, the mean age was 69.7 +/- 6.3 years, 28 (50.9%) of them were
males, the median operative risk was 1.75%. Twenty-seven (49.1%) were
randomised into the immunonutrition group. The control and the
immunonutrition groups were similar before the intervention. The counts of
the CD3+ T cells and CD4+ T cells on the sixth postoperative day were
significantly higher in the immunonutrition group compared to the control
group with 1.42 +/- 0.49 vs. 1.12 +/- 0.56 (*10⁹/l), p = 0.035
and 1.02 +/- 0.36 vs. 0.80 +/- 0.43 (*10⁹/l), p = 0.048,
respectively. Regression analysis was performed to determine the efficacy
of the immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T
and CD4+ T cell counts were increased to 0.264 (*10⁹/l), p =
0.039 and 0.232 (*10⁹/l), p = 0.021, respectively.
<br/>Conclusion(s): Early postoperative immunonutrition increases the
count of the CD3+ and CD4+ T cells in cardiac surgical patients. Clinical
trials identifier number: NCT04047095<br/>Copyright &#xa9; 2020 Elsevier
Ltd and European Society for Clinical Nutrition and Metabolism

<122>
Accession Number
631945477
Title
Subclinical leaflet thrombosis after transcatheter aortic valve
replacement: a meaningless finding? A systematic review and meta-analysis.
Source
European heart journal. Quality of care & clinical outcomes. 7 (1) (pp
107-108), 2021. Date of Publication: 25 Jan 2021.
Author
Casula M.; Fortuni F.; Ferlini M.; Mauri S.; Rebuffi C.; Rossini R.;
Ferrario M.; Oltrona Visconti L.
Institution
(Casula, Fortuni, Oltrona Visconti) Coronary Care Unit, Fondazione IRCCS
Policlinico San Matteo, Viale Camillo Golgi 19, Pavia 27100, Italy
(Casula, Fortuni) Department of Molecular Medicine, University of Pavia,
Via Forlanini 6, Pavia 27100, Italy
(Ferlini, Mauri, Ferrario, Oltrona Visconti) Division of Cardiology,
Fondazione IRCCS Policlinico San Matteo, Viale Camillo Golgi 19, Pavia
27100, Italy
(Rebuffi) Scientific Documentation Center, Fondazione IRCCS Policlinico
San Matteo, Viale Camillo Golgi, Pavia 27100, Italy
(Rossini) Cardiologia, Ospedale Santa Croce e Carle, Via Michele Coppino
26, Cuneo 12100, Italy
Publisher
NLM (Medline)

<123>
Accession Number
2007982523
Title
Effect of Omega-3 Dosage on Cardiovascular Outcomes: An Updated
Meta-Analysis and Meta-Regression of Interventional Trials.
Source
Mayo Clinic Proceedings. 96 (2) (pp 304-313), 2021. Date of Publication:
February 2021.
Author
Bernasconi A.A.; Wiest M.M.; Lavie C.J.; Milani R.V.; Laukkanen J.A.
Institution
(Bernasconi) Global Organization for EPA and DHA Omega-3s (GOED), Salt
Lake City, UT, United States
(Wiest) Department of Statistical Science, University of Idaho, Moscow,
ID, United States
(Lavie, Milani) Department of Cardiovascular Diseases, John Ochsner Heart
and Vascular Institute, Ochsner Clinical School, The University of
Queensland School of Medicine, New Orleans, LA, United States
(Laukkanen) Institute of Public Health and Clinical Nutrition, University
of Eastern Finland, Kuopio, Finland, Faculty of Sport and Health Sciences,
University of Jyvaskyla, Jyvaskyla, Finland, Department of Medicine,
Central Finland Health Care District, Jyvaskyla, Finland
Publisher
Elsevier Ltd
Abstract
Objectives: To quantify the effect of eicosapentaenoic (EPA) and
docosahexaenoic (DHA) acids on cardiovascular disease (CVD) prevention and
the effect of dosage. <br/>Method(s): This study is designed as a random
effects meta-analysis and meta-regression of randomized control trials
with EPA/DHA supplementation. This is an update and expanded analysis of a
previously published meta-analysis which covers all randomized control
trials with EPA/DHA interventions and cardiovascular outcomes published
before August 2019. The outcomes included are myocardial infarction (MI),
coronary heart disease (CHD) events, CVD events (a composite of MI,
angina, stroke, heart failure, peripheral arterial disease, sudden death,
and non-scheduled cardiovascular surgical interventions), CHD mortality
and fatal MI. The strength of evidence was assessed using the Grading of
Recommendations Assessment, Development, and Evaluation framework.
<br/>Result(s): A total of 40 studies with a combined 135,267 participants
were included. Supplementation was associated with reduced risk of MI
(relative risk [RR], 0.87; 95% CI, 0.80 to 0.96), high certainty number
needed to treat (NNT) of 272; CHD events (RR, 0.90; 95% CI, 0.84 to 0.97),
high certainty NNT of 192; fatal MI (RR, 0.65; 95% CI, 0.46 to 0.91]),
moderate certainty NNT = 128; and CHD mortality (RR, 0.91; 95% CI, 0.85 to
0.98), low certainty NNT = 431, but not CVD events (RR, 0.95; 95% CI, 0.90
to 1.00). The effect is dose dependent for CVD events and MI.
<br/>Conclusion(s): Cardiovascular disease remains the leading cause of
death worldwide. Supplementation with EPA and DHA is an effective
lifestyle strategy for CVD prevention, and the protective effect probably
increases with dosage.<br/>Copyright &#xa9; 2020 Mayo Foundation for
Medical Education and Research

<124>
Accession Number
2010260480
Title
Inhaled nitric oxide and acute kidney injury risk: a meta-analysis of
randomized controlled trials.
Source
Renal Failure. 43 (1) (pp 281-290), 2021. Date of Publication: 2021.
Author
Wang J.; Cong X.; Miao M.; Yang Y.; Zhang J.
Institution
(Wang) Journal Editorial Department, Henan Provincial People's Hospital,
People's Hospital of Zhengzhou University, Zhengzhou, China
(Cong, Miao, Yang, Zhang) Department of Anesthesiology and Perioperative
Medicine, Henan Provincial People's Hospital, People's Hospital of
Zhengzhou University, Zhengzhou, China
Publisher
Taylor and Francis Ltd.
Abstract
Purpose: There are conflicting results as to the effect of inhaled nitric
oxide (iNO) therapy on the risk of acute kidney injury (AKI). The aim of
this study was to perform a meta-analysis to assess the updated data.
<br/>Method(s): We systematically searched Web of Science, the Cochrane
Library, Wanfang, and PubMed for relevant randomized control trials
between database inception and 9/07/2020. Relative risks (RRs) with 95%
confidence intervals (CIs) predicting the risk of AKI were extracted to
obtain summary estimates using fixed-effects models. The Trim and Fill
method was used to evaluate the sensitivity of the results and adjust for
publication bias in meta-analysis. <br/>Result(s): 15 randomized
controlled studies from 14 articles involving 1853 patients were included
in the study. Analyzing the eligible studies we found: (1) iNO therapy
significantly increased the risk of AKI in acute respiratory distress
syndrome patients (RR 1.55, 95% CI 1.15-2.10, p = 0.004; I ²
for heterogeneity 0%; P <inf>het</inf> = 0.649). (2) The use of iNO was
associated with reduced AKI risk in patients undergoing cardiac surgery
(RR 0.80, 95% CI 0.64-0.99, p = 0.037; I ² for heterogeneity
0%; P <inf>het</inf> = 0.528). (3) For organ transplantation recipients,
there was no effect of iNO administration on the risk of AKI (RR 0.50, 95%
CI 0.16-1.56, p = 0.233; I ² for heterogeneity 0%; P
<inf>het</inf> = 0.842). The Trim and Fill analysis showed that the
overall effect of this meta-analysis was stable. <br/>Conclusion(s): The
effect of iNO on AKI risk might be disease-specific. Future RCTs with
larger patient populations should aim to validate our
findings.<br/>Copyright &#xa9; 2021 The Author(s). Published by Informa UK
Limited, trading as Taylor & Francis Group.

<125>
Accession Number
2010039387
Title
Efficacy and safety of lowering LDL cholesterol in older patients: a
systematic review and meta-analysis of randomised controlled trials.
Source
The Lancet. 396 (10263) (pp 1637-1643), 2020. Date of Publication: 21 Nov
2020.
Author
Gencer B.; Marston N.A.; Im K.; Cannon C.P.; Sever P.; Keech A.; Braunwald
E.; Giugliano R.P.; Sabatine M.S.
Institution
(Gencer, Marston, Im, Braunwald, Giugliano, Sabatine) TIMI Study Group,
Division of Cardiovascular Medicine, Harvard Medical School, Boston, MA,
United States
(Cannon) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
(Sever) National Heart and Lung Institute, Imperial College London,
London, United Kingdom
(Keech) National Health and Medical Research Council Clinical Trials
Centre, Sydney Medical School, University of Sydney, Sydney, NSW,
Australia
Publisher
Lancet Publishing Group
Abstract
Background: The clinical benefit of LDL cholesterol lowering treatment in
older patients remains debated. We aimed to summarise the evidence of LDL
cholesterol lowering therapies in older patients. <br/>Method(s): In this
systematic review and meta-analysis, we searched MEDLINE and Embase for
articles published between March 1, 2015, and Aug 14, 2020, without any
language restrictions. We included randomised controlled trials of
cardiovascular outcomes of an LDL cholesterol-lowering drug recommended by
the 2018 American College of Cardiology and American Heart Association
guidelines, with a median follow-up of at least 2 years and data on older
patients (aged >=75 years). We excluded trials that exclusively enrolled
participants with heart failure or on dialysis because guidelines do not
recommend lipid-lowering therapy in such patients who do not have another
indication. We extracted data for older patients using a standardised data
form for aggregated study-level data. We meta-analysed the risk ratio (RR)
for major vascular events (a composite of cardiovascular death, myocardial
infarction or other acute coronary syndrome, stroke, or coronary
revascularisation) per 1 mmol/L reduction in LDL cholesterol.
<br/>Finding(s): Data from six articles were included in the systematic
review and meta-analysis, which included 24 trials from the Cholesterol
Treatment Trialists' Collaboration meta-analysis plus five individual
trials. Among 244 090 patients from 29 trials, 21 492 (8.8%) were aged at
least 75 years, of whom 11 750 (54.7%) were from statin trials, 6209
(28.9%) from ezetimibe trials, and 3533 (16.4%) from PCSK9 inhibitor
trials. Median follow-up ranged from 2.2 years to 6.0 years. LDL
cholesterol lowering significantly reduced the risk of major vascular
events (n=3519) in older patients by 26% per 1 mmol/L reduction in LDL
cholesterol (RR 0.74 [95% CI 0.61-0.89]; p=0.0019), with no statistically
significant difference with the risk reduction in patients younger than 75
years (0.85 [0.78-0.92]; p<inf>interaction</inf>=0.37). Among older
patients, RRs were not statistically different for statin (0.82
[0.73-0.91]) and non-statin treatment (0.67 [0.47-0.95];
p<inf>interaction</inf>=0.64). The benefit of LDL cholesterol lowering in
older patients was observed for each component of the composite, including
cardiovascular death (0.85 [0.74-0.98]), myocardial infarction (0.80
[0.71-0.90]), stroke (0.73 [0.61-0.87]), and coronary revascularisation
(0.80 [0.66-0.96]). <br/>Interpretation(s): In patients aged 75 years and
older, lipid lowering was as effective in reducing cardiovascular events
as it was in patients younger than 75 years. These results should
strengthen guideline recommendations for the use of lipid-lowering
therapies, including non-statin treatment, in older patients.
<br/>Funding(s): None.<br/>Copyright &#xa9; 2020 Elsevier Ltd

<126>
Accession Number
633959441
Title
PICS-AICS Virtual Symposium.
Source
Pediatric Cardiology. Conference: PICS-AICS Virtual Symposium. 41 (6) (no
pagination), 2020. Date of Publication: August 2020.
Author
Anonymous
Publisher
Springer
Abstract
The proceedings contain 104 papers. The topics discussed include: surgical
treatment of infants with critical aortic stenosis; immediate vs. staged
multi-vessel PCI strategy for patients with STEMI and multi-vessel
disease: a systematic review and meta-analysis; atretic aortic
coarctation: usefulness of microcatheter and CTO wires; early results of
PT valve in native right ventricular outflow tract for patients with
severe pulmonary regurgitation; juxtaposition of atrial appendages and ASD
device closure - the truth in the lie; evaluation of short and
intermediate-term follow-up results of percutaneous closure of ventricular
septal defects using different devices: a single-center experience from
Mansoura, Egypt; hypoxemia following balloon pulmonary valvuloplasty for
critical pulmonary stenosis; and short-term outcomes of percutaneous
device closure of patent ductus arteriosus using the amplatzer duct
occluder device in comparison to the nitoccluder PDA-R device.

<127>
Accession Number
2010356512
Title
Comparison of the in-vivo effect of two tranexamic acid doses on
fibrinolysis parameters in adults undergoing valvular cardiac surgery with
cardiopulmonary bypass - a pilot investigation.
Source
BMC Anesthesiology. 21 (1) (no pagination), 2021. Article Number: 33. Date
of Publication: December 2021.
Author
Zhou Z.-F.; Zhai W.; Yu L.-N.; Sun K.; Sun L.-H.; Xing X.-F.; Yan M.
Institution
(Zhou, Zhai, Yu, Sun, Xing, Yan) Department of Anesthesiology, The Second
Affiliated Hospital, School of Medicine Zhejiang University, Hangzhou,
China
(Zhou) Department of Anesthesiology, Hangzhou Women's Hospital (The
Affiliated Women's Hospital of Hangzhou Normal University), Hangzhou,
China
(Zhai) Department of Anesthesiology, Zhejiang Provincial People's Hospital
(People's Hospital of Hangzhou Medicine College), Hangzhou, China
(Sun) Department of Anesthesiology, Women's Hospital, School of Medicine
Zhejiang University, Hangzhou, China
Publisher
BioMed Central Ltd
Abstract
Background: The blood saving efficacy of TXA in cardiac surgery has been
proved in several studies, but TXA dosing regimens were varied in those
studies. Therefore, we performed this study to investigate if there is a
dose dependent in-vivo effect of TXA on fibrinolysis parameters by
measurement of fibrinolysis markers in adults undergoing cardiac surgery
with CPB. <br/>Method(s): A double-blind, randomized, controlled
prospective trial was conducted from February 11, 2017 to May 05, 2017.
Thirty patients undergoing cardiac valve surgery were identified and
randomly divided into a placebo group, low-dose group and high-dose group
by 1: 1: 1. Fibrinolysis parameters were measured by plasma levels of
D-Dimers, plasminogen activator inhibitor-1 (PAI-1), thrombin activatable
fibrinolysis inhibitor (TAFI), plasmin-antiplasmin complex (PAP), tissue
plasminogen activator (tPA) and thrombomodulin (TM). Those proteins were
measured at five different sample times: preoperatively before the TXA
injection (T<inf>1</inf>), 5 min after the TXA bolus (T<inf>2</inf>), 5
min after the initiation of CPB (T<inf>3</inf>), 5 min before the end of
CPB (T<inf>4</inf>) and 5 min after the protamine administration
(T<inf>5</inf>). A Thrombelastography (TEG) and standard coagulation test
were also performed. <br/>Result(s): Compared with the control group, the
level of the D-Dimers decreased in the low-dose and high-dose groups when
the patients arrived at the ICU and on the first postoperative morning.
Over time, the concentrations of PAI-1, TAFI, and TM, but not PAP and tPA,
showed significant differences between the three groups (P < 0.05).
Compared with the placebo group, the plasma concentrations of PAI-1 and
TAFI decreased significantly at the T3 and T4 (P < 0.05); TAFI
concentrations also decreased at the T5 in low-dose group (P < 0.05).
Compared with the low-dose group, the concentration of TM increased
significantly at the T4 in high-dose group. <br/>Conclusion(s): The
in-vivo effect of low dose TXA is equivalent to high dose TXA on
fibrinolysis parameters in adults with a low bleeding risk undergoing
valvular cardiac surgery with cardiopulmonary bypass, and a low dose TXA
regimen might be equivalent to high dose TXA for those patients. Trial
registration: ChiCTR-IPR-17010303, Principal investigator: Zhen-feng ZHOU,
Date of registration: January 1, 2017.<br/>Copyright &#xa9; 2021, The
Author(s).

<128>
Accession Number
2005945339
Title
Constrictive pericarditis: The effectiveness of conservative medical
therapy versus surgical pericardectomy.
Source
International Cardiovascular Research Journal. 14 (4) (pp 142-147), 2020.
Article Number: e110214. Date of Publication: 2020.
Author
Peyghambari M.M.; Alizadehasl A.; Rostambeigi S.; Ghavidel A.; Ghobadi E.;
Ebrahimian M.; Parsa N.A.; Rahbar Z.
Institution
(Peyghambari, Alizadehasl, Rostambeigi, Ghavidel, Ghobadi, Parsa, Rahbar)
Rajaie Cardiovascular, Medical, and Research Center, Iran University of
Medical sciences, Tehran, IR, Iran, Islamic Republic of
(Ebrahimian) Resident of General Surgery, Shahid Beheshti University of
Medical Sciences, Loghman Medical Center, Tehran, IR, Iran, Islamic
Republic of
Publisher
Iranian Cardiovascular Research Journal
Abstract
Background: Pericarditis is an uncommon but important disease that can
lead to severe symptoms and mortality. <br/>Objective(s): This study aimed
to evaluate the outcomes of constrictive pericarditis treated by
conservative medical therapy in comparison to surgical pericardiectomy.
<br/>Method(s): In this retrospective study, the records of the patients
diagnosed with constrictive pericarditis in Rajaie Cardiovascular,
Medical, and Research Center from October 2007 to December 2017 were
reviewed. Among the patients, 38 were treated by medical therapy. Thus, 38
patients treated by surgical pericardiectomy were randomly selected to be
compared to the medical therapy group. The two groups were compared with
regard to the clinical outcomes. Intergroup comparisons were made using
chi-square test. In addition, Wilcoxon's signed-rank test was used to
compare the patients' New York Heart Association (NYHA) functional classes
before and after the treatment. Statistical analysis was performed using
IBM SPSS Statistics, version 16. <br/>Result(s): The mean age of the
patients was 51.68 +/- 16.37 years in the medical therapy group and 48.43
+/- 17.04 years in the surgery group. The main symptoms were dyspnea and
edema. Besides, the most common causes were idiopathic (64.4%) and
tuberculosis (17.1%) followed by uremia (15.7%) and malignancy (6.5%).
Moreover, 84.2% of the patients in the medical therapy group and 97.3% of
those in the surgical pericardiectomy group experienced at least one NYHA
functional class status, but the difference was not statistically
significant. Edema was decreased in 15 out of the 24 patients in the
medical therapy group (62.5%) and in 18 out of the 27 patients who had
undergone surgical percardiectomy (66.6%), but this difference was not
statistically significant (P = 0.74). Furthermore, nine patients in the
conservative medical therapy group had been re-hospitalized within the
first year of treatment (23.8%), while this measure was found to be six in
the surgical pericardiectomy group (15.7%), and the difference was not
statistically significant (P = 0.3783). Finally, the perioperative
mortality rate was 2.6%, and long-term mortality rate was equal in the two
groups (7.8%). <br/>Conclusion(s): Conservative medical therapy based on
the severity and cause of constrictive pericarditis could improve clinical
outcomes, especially in patients with transient types of constrictive
pericarditis as well as in those who were at a high risk for
surgery.<br/>Copyright &#xa9; 2020, Iranian Cardiovascular Research
Journal. All rights reserved.

<129>
Accession Number
2005945338
Title
Comparing vancomycin-tranexamic acid paste to vancomycin-normal saline
paste in reducing post coronary artery bypass graft surgery bleeding.
Source
International Cardiovascular Research Journal. 14 (4) (pp 137-141), 2020.
Article Number: e103103. Date of Publication: 2020.
Author
Mirmohammadsadeghi A.; Asadollahi H.
Institution
(Mirmohammadsadeghi, Asadollahi) Cardiovascular Surgery Department,
Isfahan University of Medical Sciences (IUMS), Isfahan, Iran, Islamic
Republic of
Publisher
Iranian Cardiovascular Research Journal
Abstract
Background: Postoperative bleeding is a common problem, specially in
cardiac surgery. The bone edges at the sternotomy site are one of the
major sites of bleeding. Previously, some materials, such as vancomycin
paste, have been applied to the sternum prior to the closure of sternum in
order to reduce postoperative hemorrhage. In addition, fibrinolytic drugs,
such as tranexamic acid, have been used locally to reduce postoperative
bleeding. <br/>Objective(s): This study aimed to assess the effect of
vancomycin paste made with tranexamic acid on reducing postoperative
mediastinal bleeding. <br/>Method(s): In this double-blind clinical trial,
all patients undergoing on-pump coronary artery bypass graft surgery were
included and divided into two groups by simple randomization method. In
the control group, two grams of vancomycin paste were made with two mls of
normal saline solution. In the intervention group, two grams of vancomycin
paste were made with two mls (containing 200 mgs) of tranexamic acid. The
paste in each group was applied to the sternal bone edges just prior to
sternal closure. Both groups were compared in terms of demographic data,
operation data, packed red blood cell transfusion, hemoglobin change, and
amount of postoperative bleeding 12, 24, and 48 hours post-surgery.
Postoperative sternal wound infection and dehiscence were also evaluated
two months after the surgery. Comparisons were done using independent
t-test, Fisher's exact test, and Mann-Whitney test using the SPSS
software, version 22. <br/>Result(s): Fifty patients completed the trial.
Both groups were similar regarding the demographic data and operation
data, such as pump time and operation duration. The amount of
postoperative bleeding was respectively 268, 624, and 844 mls in the
control group and 174, 362, and 485 mls in the invention group 12, 24, and
48 hours after the operation (P < 0.001). The results revealed no
significant difference between the two groups concerning postoperative
transfusion and hemoglobin changes. Postoperative sternal wound
complications, including infection and dehiscence, were not seen in any of
the study groups. <br/>Conclusion(s): In comparison to vancomycin paste
alone, vancomycin-tranexamic acid paste had a significantly superior
effect on the reduction of post-coronary artery bypass graft surgery
bleeding.<br/>Copyright &#xa9; 2020, Iranian Cardiovascular Research
Journal. All rights reserved.

<130>
Accession Number
2010596137
Title
Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical
Aortic Valve Replacement: An Updated Meta-Analysis.
Source
JACC: Cardiovascular Interventions. 14 (2) (pp 211-220), 2021. Date of
Publication: 25 Jan 2021.
Author
Sa M.P.B.O.; Van den Eynde J.; Simonato M.; Cavalcanti L.R.P.; Doulamis
I.P.; Weixler V.; Kampaktsis P.N.; Gallo M.; Laforgia P.L.; Zhigalov K.;
Ruhparwar A.; Weymann A.; Pibarot P.; Clavel M.-A.
Institution
(Sa, Cavalcanti) Division of Cardiovascular Surgery of Pronto Socorro
Cardiologico de Pernambuco-PROCAPE, University of Pernambuco-UPE, Recife,
Brazil
(Van den Eynde) Department of Cardiovascular Diseases, Research Unit of
Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium
(Van den Eynde) Department of Cardiovascular Sciences, KU Leuven, Leuven,
Belgium
(Simonato) Division of Cardiac Surgery, Escola Paulista de
Medicina-UNIFESP, Sao Paulo, Brazil
(Doulamis) Department of Cardiac Surgery, Boston Children's Hospital,
Harvard Medical School, Boston, MA, United States
(Weixler) German Heart Center, Berlin, Germany
(Kampaktsis) NYU Langone Medical Center, New York, NY, United States
(Gallo) Department of Cardiac Surgery, Cardiocentro Ticino, Lugano,
Switzerland
(Laforgia) I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Milan,
Italy
(Zhigalov, Ruhparwar, Weymann) Department of Thoracic and Cardiovascular
Surgery, West German Heart and Vascular Center Essen, University Hospital
of Essen, University Duisburg-Essen, Essen, Germany
(Pibarot, Clavel) Centre de Recherche de l'Institut Universitaire de
Cardiologie et de Pneumologie de Quebec, Quebec City, Quebec, Canada
(Pibarot, Clavel) Department of Medicine, Faculty of Medicine, Universite
Laval, Quebec City, Quebec, Canada
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to evaluate early results of
valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus
redo surgical aortic valve replacement (SAVR) for structural valve
degeneration (SVD). <br/>Background(s): ViV TAVR has been increasingly
used for SVD, but it remains unknown whether it produces better or at
least comparable results as redo SAVR. <br/>Method(s): Observational
studies comparing ViV TAVR and redo SAVR were identified in a systematic
search of published research. Random-effects meta-analysis was performed,
comparing clinical outcomes between the 2 groups. <br/>Result(s): Twelve
publications including a total of 16,207 patients (ViV TAVR, n = 8,048;
redo SAVR, n = 8,159) were included from studies published from 2015 to
2020. In the pooled analysis, ViV TAVR was associated with lower rates of
30-day mortality overall (odds ratio [OR]: 0.53; 95% confidence interval
[CI]: 0.32 to 0.87; p = 0.017) and for matched populations (OR: 0.419; 95%
CI: 0.278 to 0.632; p = 0.003), stroke (OR: 0.65; 95% CI: 0.55 to 0.76; p
< 0.001), permanent pacemaker implantation (OR: 0.73; 95% CI: 0.22 to
2.43; p = 0.536), and major bleeding (OR: 0.49; 95% CI: 0.26 to 0.93; p =
0.034), as well as with shorter hospital stay (OR: -3.30; 95% CI: -4.52 to
-2.08; p < 0.001). In contrast, ViV TAVR was associated with higher rates
of myocardial infarction (OR: 1.50; 95% CI: 1.01 to 2.23; p = 0.045) and
severe patient-prosthesis mismatch (OR: 4.63; 95% CI: 3.05 to 7.03; p <
0.001). The search revealed an important lack of comparative studies with
long-term results. <br/>Conclusion(s): ViV TAVR is a valuable option in
the treatment of patients with SVD because of its lower incidence of
post-operative complications and better early survival compared with redo
SAVR. However, ViV TAVR is associated with higher rates of myocardial
infarction and severe patient-prosthesis mismatch.<br/>Copyright &#xa9;
2021 American College of Cardiology Foundation

<131>
Accession Number
2010784965
Title
An immediate or early invasive strategy in non-ST-elevation acute coronary
syndrome: The OPTIMA-2 randomized controlled trial.
Source
American Heart Journal. 234 (pp 42-50), 2021. Date of Publication: April
2021.
Author
Fagel N.D.; Amoroso G.; Vink M.A.; Slagboom T.; van der Schaaf R.J.;
Herrman J.-P.; Patterson M.S.; Oosterwerff E.F.J.; Vos N.S.; Verheugt
F.W.A.; Tijssen J.G.P.; de Winter R.J.; Riezebos R.K.
Institution
(Fagel, Amoroso, Vink, Slagboom, van der Schaaf, Herrman, Patterson, Vos,
Verheugt, Riezebos) Heart Center, OLVG Hospital, Amsterdam, Netherlands
(Oosterwerff) Division of Cardiology, Isala Hospital, Zwolle, Netherlands
(Tijssen, de Winter) Division of Cardiology, Amsterdam UMC Location AMC,
Amsterdam, Netherlands
Publisher
Mosby Inc.
Abstract
Background: In intermediate- and high-risk non-ST elevated acute coronary
syndrome (NSTE-ACS) patients, a routine invasive approach is recommended.
The timing of coronary angiography remains controversial. To assess
whether an immediate (<3 hours) invasive treatment strategy would reduce
infarct size and is safe, compared with an early strategy (12-24 hours),
for patients admitted with NSTE-ACS while preferably treated with
ticagrelor. <br/>Method(s): In this single-center, prospective, randomized
trial an immediate or early invasive strategy was randomly assigned to
patients with NSTE-ACS. At admission, the patients were preferably treated
with a combination of aspirin, ticagrelor and fondaparinux. The primary
endpoint was the infarct size as measured by area under the curve (AUC) of
CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major
adverse cardiac events (MACE): composite of all-cause death, MI and
unplanned revascularization. Interim analysis showed futility regarding
the primary endpoint and trial inclusion was terminated. <br/>Result(s):
In total 249 patients (71% of planned) were included. The primary endpoint
of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the
immediate group (IQR 112-618) and 201.3 ng/mL in the early group (IQR
119-479). Clinical follow-up was 1-year. The MACE-rate was 10% in the
immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI:
0.52-2.49). <br/>Conclusion(s): In NSTE-ACS patients randomized to either
an immediate or an early-invasive strategy the observed median difference
in the primary endpoint was about half the magnitude of the expected
difference. The trial was terminated early for futility after 71% of the
projected enrollment had been randomized into the trial.<br/>Copyright
&#xa9; 2021 Elsevier Inc.

<132>
Accession Number
2010024722
Title
Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid
Aortic Valves.
Source
Journal of the American College of Cardiology. 76 (22) (pp 2579-2590),
2020. Date of Publication: 01 Dec 2020.
Author
Fan J.; Fang X.; Liu C.; Zhu G.; Hou C.R.; Jiang J.; Lin X.; Wang L.; He
Y.; Zhu Q.; Ng S.; Chen Z.; Hu H.; Liu X.; Wang J.; Leon M.B.
Institution
(Fan, Liu, Zhu, Jiang, Lin, Wang, He, Zhu, Liu, Wang) Department of
Cardiology, Second Affiliated Hospital, Zhejiang University School of
Medicine, Hangzhou, China
(Fang, Ng, Liu, Wang) Zhejiang University School of Medicine, Hangzhou,
China
(Fang) Department of Cardiology, Lanxi People's Hospital, Lanxi, China
(Hou) College of Biological Sciences, University of Minnesota Twin Cities,
Minneapolis, MN, United States
(Chen) Department of Clinical Epidemiology and Biostatistics, Second
Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou,
China
(Hu) Department of Neurology, Second Affiliated Hospital, Zhejiang
University School of Medicine, Hangzhou, China
(Leon) Columbia University Medical Center, New York, NY, United States
(Leon) Cardiovascular Research Foundation, New York, NY, United States
Publisher
Elsevier Inc.
Abstract
Background: An increasing number of bicuspid aortic valve (BAV) patients
are undergoing transcatheter aortic valve replacement (TAVR), but the risk
of brain injury in diffusion-weighted magnetic resonance imaging (DW-MRI)
is currently unknown. <br/>Objective(s): This study sought to evaluate the
risk of brain injury in BAV patients following TAVR. <br/>Method(s): A
total of 204 consecutive severe aortic stenosis patients who underwent
TAVR were enrolled. A total of 83 (40.7%) patients were BAV patients, and
the other 121 patients were tricuspid aortic valve (TAV) patients. All
patients received DW-MRI at baseline, and after TAVR. <br/>Result(s):
Median ages (76 years [interquartile range (IQR): 71 to 81 years] vs. 79
years [IQR: 74 to 83 years]; p = 0.004) and Society of Thoracic Surgeons
scores (4.87 [IQR: 3.72 to 8.54] vs. 6.38 [IQR: 3.96 to 9.50]; p = 0.044)
of the BAV and TAV patients were significantly different, while the overt
stroke rates (2.4% vs. 1.7%; p = 0.704) were comparable between the 2
groups. BAV patients were associated with higher number of new lesions
(4.0 [IQR: 1.0 to 8.0] vs. 2.0 [IQR: 1.0 to 5.0]; p = 0.008), total lesion
volume (290 mm³ [IQR: 70 to 930 mm³] vs. 140
mm³ [IQR: 35 to 480 mm³]; p = 0.008), and the volume
per lesion (70.0 mm³ [IQR: 45.0 to 115.0 mm³] vs.
57.5 mm³ [IQR: 24.5 to 93.0 mm³]; p = 0.037) in
DW-MRI. Moreover, the proportion of patients with lesions larger than 1
cm³ (28.6% vs. 10.9%; p = 0.005) was higher in BAV patients
than in TAV patients. <br/>Conclusion(s): BAV patients may encounter more
severe brain injuries not only due to greater number of lesions, but also
due to larger lesion size in the early phase after TAVR. (Transcatheter
Aortic Valve Replacement Single Center Registry in Chinese Population
[TORCH]; NCT02803294)<br/>Copyright &#xa9; 2020 The Authors

<133>
Accession Number
2005455794
Title
Quality of life after coronary artery bypass surgery: A systematic review
and meta-analysis.
Source
International Journal of Environmental Research and Public Health. 17 (22)
(pp 1-12), 2020. Article Number: 8439. Date of Publication: 02 Nov 2020.
Author
Schmidt-Riovalle J.; Ejheisheh M.A.; Membrive-Jimenez M.J.;
Suleiman-Martos N.; Albendin-Garcia L.; Correa-Rodriguez M.; Gomez-Urquiza
J.L.
Institution
(Schmidt-Riovalle, Ejheisheh, Suleiman-Martos, Albendin-Garcia,
Correa-Rodriguez, Gomez-Urquiza) Faculty of Health Sciences, University of
Granada, Avenida de la Ilustracion N. 60, Granada 18016, Spain
(Membrive-Jimenez) Institute of Health Management, University Hospital of
Ceuta, C/Colmenar, s/n, Ceuta 51003, Spain
Publisher
MDPI AG
Abstract
Coronary heart disease is a public health problem and is one of the
leading causes of loss of quality of life, disability, and death
worldwide. The main procedure these patients undergo is cardiac
catheterisation, which helps improve their quality of life, symptoms of
myocardial ischemia, and ventricular function, thus helping increase the
survival rate of sufferers. It can also, however, lead to physical
consequences, including kidney failure, acute myocardial infarction, and
stroke. The objective of this study was to analyse how coronary artery
bypass grafting (CABG) influences quality of life. A systematic review and
meta-analysis were conducted using the CINAHL, PubMed, Scopus, and Cuiden
databases in June 2020. A total of 7537 subjects were included, 16 in the
systematic review and 3 in the meta-analysis. The studies analysing
quality of life using the SF questionnaire showed improvements in the
quality of physical and mental appearance, and those using the NHP
questionnaire showed score improvements and, in some cases, differences in
quality of life between women and men. This operation seems to be a good
choice for improving the quality of life of people with coronary
pathologies, once the possible existing risks have been
assessed.<br/>Copyright &#xa9; 2020, MDPI AG. All rights reserved.

<134>
Accession Number
2005790992
Title
Inhalation vs total intravenous anesthesia in cancer surgery: Where is the
<<pendulum>> now? (meta-analysis and review).
Source
Obshchaya Reanimatologiya. 16 (6) (pp 91-104), 2020. Date of Publication:
2020.
Author
Likhvantsev V.V.; Yadgarov M.; Di Piazza M.; Kadantseva K.
Institution
(Likhvantsev, Yadgarov, Kadantseva) V. A. Negovsky Research Institute of
General Reanimatology, Federal Research and Clinical Center of Intensive
Care Medicine and Rehabilitology, 25 Petrovka Str., Build. 2, Moscow
107031, Russian Federation
(Di Piazza) Department of Anesthesia and Intensive Care, IRCCS San
Raffaele Scientific Institute, Via Olgettina, 60, Milan 20132, Italy
Publisher
V.A. Negovsky Research Institute of General Reanimatology
Abstract
Comparative studies on the efficacy and safety of Inhalation Anesthesia
(IA) and Total IntraVenous Anesthesia (TIVA) have been performed for many
years, and the results were various. The aim of this study was to evaluate
new data on the clinical efficacy of anesthetic preconditioning, the
difference between inhalation and intravenous anesthesia on cardiac
protection and clinically relevant outcomes in cancer surgery. Materials
and methods. We carried out a systematic review and meta-analysis on
searches and analysis of the literature over the past five years in
accordance to the recommendations of the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results. Out of
the 759 articles which were initially identified, we selected 3 studies
regarding the clinical significance of anesthetic cardioprotection and 10
studies comparing IA and TIVA in patients undergoing surgery for malignant
diseases. Two meta-analyses and one multi-regional clinical trial (MRCT)
suggest that further studies of the effectiveness of anesthetic
cardioprotection is futile. A meta-analysis of 9 retrospective cohort
studies and 1 MRCT showed a detrimental effect of IA on 3-year survival in
surgical oncology (Hazard Ratio (HR): 1.73 (1.36; 1.96) Heterogeneity: Q =
8.336, df = 3, I²; f² = 64.01, overall effect
analysis: Z = 2.386 (P<0.017)). Analysis of 5-year mortality did not
reveal any differences, although it did not remove any doubts about the
possible negative effect of the use of IA in surgical oncology.
Conclusion. Due to the futility of the previous efforts, the authors
suggest not starting new studies aimed at finding evidence of the
effectiveness of anesthetic cardioprotection on clinically relevant
outcomes. How-ever, since cohort studies indicate a possible beneficial
effect of the use of TIVA in surgical oncology, the authors suggest
conducting a serious comparative MRCT in this setting.<br/>Copyright
&#xa9; 2020, V.A. Negovsky Research Institute of General Reanimatology.
All rights reserved.

<135>
Accession Number
2010217649
Title
Enhanced recovery after cardiac surgery and its impact on outcomes: A
systematic review.
Source
Perfusion (United Kingdom). (no pagination), 2021. Date of Publication:
2021.
Author
Zhang Y.; Chong J.H.; Harky A.
Institution
(Zhang) Barts and The London School of Medicine and Dentistry, London,
United Kingdom
(Chong) GKT School of Medical Education, King's College London, London,
United Kingdom
(Harky) Department of Cardiothoracic Surgery, Liverpool Heart and Chest,
Liverpool, United Kingdom
(Harky) Department of Integrative Biology, Faculty of Life Science,
University of Liverpool, Liverpool, United Kingdom
(Harky) Liverpool Centre for Cardiovascular Science, University of
Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United
Kingdom
(Harky) Department of Cardiac Surgery, Alder Hey Children Hospital,
Liverpool, United Kingdom
Publisher
SAGE Publications Ltd
Abstract
Background and Aim: Enhanced Recovery After Surgery (ERAS) protocols are a
series of perioperative interventions well-established in improving the
care and outcomes of patients. With recent emergence of studies on its
implementation in cardiac surgery, this paper represents the first
systematic review on current evidence of ERAS efficacy in this field.
<br/>Method(s): Two reviewers independently searched through Pubmed,
Cochrane, Google Scholar, Web of Science, Embase and Scopus. Comparative
studies with controls that described the implementation of ERAS in all
types of cardiac operations from 2001 to 2020 were included. Data
extracted included patient demographics, components of ERAS protocol
described, types of cardiac surgery, and postoperative outcomes.
<br/>Result(s): In the final analysis, nine studies were included, of
which there were one randomized controlled trial (RCT), one
quasi-experiment and seven retrospective/prospective studies. Significant
improvement in hospital and ICU length of stay, as well as reduction in
postoperative opioid consumption were demonstrated. No increase in
postoperative complications were reported. <br/>Conclusion(s): ERAS in
cardiac surgery has shown to be potentially safe and effective in
improving certain postoperative outcomes. However, the evidence is limited
by the lack of high-quality RCTs. We also found the lack of practice of
class 1 recommended interventions set forth by the ERAS Cardiac Society.
Furthermore, majority of studies only evaluated the immediate
postoperative outcomes of patients, and not the long-term outcomes. RCTs
that fully implement measures recommended by the ERAS Cardiac Society,
with assessments on both immediate and long-term outcomes, are
warranted.<br/>Copyright &#xa9; The Author(s) 2021.

<136>
Accession Number
2010201846
Title
Evaluation of a novel Cardiac Peri-Operative Transfusion Trigger Scoring
system in patients with coronary artery disease.
Source
BMC Cardiovascular Disorders. 21 (1) (no pagination), 2021. Article
Number: 40. Date of Publication: December 2021.
Author
Ma H.-P.; Zhang L.; Chen C.-L.; Li J.; Ma Z.T.; Jiang Q.Q.; Liang Y.Y.; Li
S.S.; Long F.; Zheng H.
Institution
(Ma, Zhang, Chen, Li, Ma, Jiang, Liang, Li, Long, Zheng) Department of
Anesthesiology, The First Affiliated Hospital of Xinjiang Medical
University, 37 Liyushan South Road, Xinshi District, Urumqi, Xinjiang
830054, China
Publisher
BioMed Central Ltd
Abstract
Background: A simple and accurate scoring system to guide perioperative
blood transfusion in patients with coronary artery disease (CAD)
undergoing cardiac surgery is lacking. The trigger point for blood
transfusions for these patients may be different from existing transfusion
guidelines. This study aimed to evaluate the safety and efficacy of a new
scoring strategy for use in guiding transfusion decisions in patients with
CAD. <br/>Method(s): A multicenter randomized controlled trial was
conducted at three third-level grade-A hospitals from January 2015 to May
2018. Data of 254 patients in a Cardiac Peri-Operative Transfusion Trigger
Score (cPOTTS) group and 246 patients in a group receiving conventional
evaluation of the need for transfusion (conventional group) were analysed.
The requirements for transfusion and the per capita consumption of red
blood cells (RBCs) were compared between groups. <br/>Result(s): Baseline
characteristics of the two groups were comparable. Logistic regression
analyses revealed no significant differences between the two groups in
primary outcomes (1-year mortality and perioperative ischemic cardiac
events), secondary outcomes (shock, infections, and renal impairment), ICU
admission, and ICU stay duration. However, patients in the cPOTTS group
had significantly shorter hospital stays, lower hospital costs, lower
utilization rate and lower per capita consumption of transfused RBCs than
controls. Stratified analyses revealed no significant differences between
groups in associations between baseline characteristics and perioperative
ischemic cardiac events, except for hemofiltration or dialysis and NYHA
class in I. <br/>Conclusion(s): This novel scoring system offered a
practical and straightforward guideline of perioperative blood transfusion
in patients with CAD. Trial registration
chiCTR1800016561(2017/7/19).<br/>Copyright &#xa9; 2021, The Author(s).

<137>
Accession Number
2006096658
Title
Nitric oxide added to the sweep gas of the oxygenator during
cardiopulmonary bypass in infants: A pilot randomized controlled trial.
Source
Artificial Organs. 45 (1) (pp 22-28), 2021. Date of Publication: January
2021.
Author
Niebler R.A.; Chiang-Ching H.; Daley K.; Janecke R.; Jobe S.M.; Mitchell
M.E.; Varner C.; Woods K.; Scott J.P.
Institution
(Niebler, Jobe, Woods) Departments of Pediatrics, Medical College of
Wisconsin, Milwaukee, WI, United States
(Niebler, Daley, Mitchell, Varner, Scott) Herma Heart Institute,
Children's Wisconsin, Milwaukee, WI, United States
(Chiang-Ching) School of Public Health, University of Wisconsin,
Milwaukee, WI, United States
(Janecke, Jobe) Versiti Blood Research Institute, Milwaukee, WI, United
States
(Mitchell) Departments of Cardiothoracic Surgery, Medical College of
Wisconsin, Milwaukee, WI, United States
(Scott) Departments of Anesthesia, Medical College of Wisconsin,
Milwaukee, WI, United States
Publisher
Blackwell Publishing Inc.
Abstract
Our objective was to assess the effect of nitric oxide added to the sweep
gas of the oxygenator during cardiopulmonary bypass (CPB) in infants on
platelet count, platelet function, clinical outcomes, and safety. A
randomized, double-blinded, placebo-controlled clinical trial in infants
less than a year of age undergoing cardiac surgery requiring CPB was
undertaken. Nitric oxide at a dose of 20 ppm was added to the sweep gas in
the treatment group. Blood was collected at baseline and prior to
separation from CPB to measure platelet count and function as determined
by responsiveness to specific agonists. Clinical outcomes were observed
through hospital discharge. Methemoglobin levels were measured
preoperatively, at the conclusion of CPB, and upon admission to the ICU.
Forty patients consented and were randomized in the trial. Eighteen
patients were randomized to the treatment group and 22 were included in
the placebo group. The groups were similar in terms of age, weight,
gender, and surgical complexity. No significant differences were found in
measures of platelet count, platelet response to agonist, or clinical
outcomes. Patients in the treatment group had higher methemoglobin levels
after receiving nitric oxide, but no levels approached toxicity (maximum
2.4%). Nitric oxide added to the sweep gas of the oxygenator during CPB in
infants did not have an appreciable effect on the preservation of platelet
count, platelet responsiveness to agonist, or clinical outcomes.
Methemoglobin levels were increased after receiving nitric oxide but were
far below a toxic level of 15%.<br/>Copyright &#xa9; 2020 International
Center for Artificial Organ and Transplantation (ICAOT) and Wiley
Periodicals LLC.

<138>
Accession Number
2005908976
Title
Incidence, risk factors, and outcomes of coronary obstruction following
valve-in-valve transcatheter aortic valve replacement: A systematic review
and meta-analysis.
Source
International Heart Journal. 62 (1) (pp 104-111), 2021. Date of
Publication: 2021.
Author
Gao Z.; Wang Y.; Qian D.; Jin J.
Institution
(Gao, Wang, Qian, Jin) Institute of Cardiovascular Diseases of PLA,
Chongqing, China
(Gao, Wang, Qian, Jin) Department of Cardiology, Xinqiao Hospital, Army
Medical University (Third Military Medical University), Chongqing, China
Publisher
International Heart Journal Association
Abstract
There is scant information about the incidence, risk factors, and outcomes
of coronary obstruction (CO) following valve-in-valve transcatheter aortic
valve replacement (VIV-TAVR). A meta-analysis of the published studies
from January 2000 to April 2020 was conducted, and the endpoint was CO. A
total of 2858 patients were enrolled in this study. The mean age was 77.7
+/- 9.8, and 39.9% of them were female. The Society of Thoracic Surgeons
(STS) score, European System for Cardiac Operative Risk Evaluation
(EuroSCORE), and Logistic EuroSCORE were 8.9 +/- 7.8, 16.0 +/- 10.9, and
26.3 +/- 16.3, respectively. The overall incidence of CO was 2.58%. CO
incidence between patients with prior stented and stentless valves were
significantly different (1.67% versus 7.17%), with an odds ratio (OR) of
0.25 and a 95% confidence interval (CI) of 0.14-0.44 (P < 0.00001). The
first-generation valves were significantly associated with higher CO
incidence compared with the second-generation valves (7.09% versus 2.03%;
OR, 2.44; 95%CI, 1.06-5.62; P = 0.04), while no statistical difference was
found between self-expandable valves and balloon-expandable valves (2.45%
versus 2.60%; OR, 0.99; 95%CI, 0.55-1.79; P = 0.98). Virtual transcatheter
to coronary ostia (VTC) distance (3.3 +/- 2.1 mm, n = 29 versus 5.8 +/-
2.4 mm, n = 169; mean difference, -2.70; 95%CI, -3.46 to -1.95; P <
0.00001) and the sinus of Valsalva (SOV) diameter (27.5 +/- 3.8 mm, n = 23
versus 32.3 +/- 4.0 mm, n = 101; mean difference, -3.80; 95%CI, -6.55 to
-1.05; P = 0.007) were enormously shorter in patients with CO. The
24-hour, in-hospital, and 30-day mortality of patients with CO were 10.5%,
30.8%, and 37.1%, respectively. In conclusion, device selections, VTC
distances, and SOV diameters may be important factors in assessing the CO
risk in VIV-TAVR. (Int Heart J 2021; 62: 104-111).<br/>Copyright &#xa9;
2021, International Heart Journal Association. All rights reserved.

<139>
Accession Number
2004098379
Title
Evaluating the role of transesophageal echocardiography (TEE) or
intracardiac echocardiography (ICE) in left atrial appendage occlusion: a
meta-analysis.
Source
Journal of Interventional Cardiac Electrophysiology. 60 (1) (pp 41-48),
2021. Date of Publication: January 2021.
Author
Akella K.; Murtaza G.; Turagam M.; Sharma S.; Madoukh B.; Amin A.;
Gopinathannair R.; Lakkireddy D.
Institution
(Akella, Murtaza, Gopinathannair, Lakkireddy) The Kansas City Heart Rhythm
Institute (KCHRI) HCA MidWest, Overland Park Regional Medical Center,
12200 W 106th Street, Overland Park, KS 66215, United States
(Turagam) Division of Cardiology, Icahn School of Medicine at Mount Sinai,
New York, NY, United States
(Sharma) Department of Cardiology, Garden City Hospital, Garden City, MI,
United States
(Madoukh) Department of Internal Medicine, Overland Park Regional Medical
Center, Overland Park, KS, United States
(Amin) Section of Cardiac Electrophysiology, Department of Cardiology,
OhioHealth Heart and Vascular Physicians, Riverside Methodist Hospital,
3535 Olentangy River Road, Columbus, OH 43214, United States
Publisher
Springer
Abstract
Purpose: Intracardiac echocardiography (ICE) is increasingly common among
periprocedural imaging modalities used during complex cardiac procedures.
We sought to perform a meta-analysis comparing transesophageal
echocardiography (TEE) and ICE in endocardial left atrial appendage
occlusion (LAAO). <br/>Method(s): We searched PubMed and Google Scholar
regarding abstracts and manuscripts using keywords: atrial fibrillation,
left atrial appendage occlusion, Watchman, Amplatzer Cardiac Plug, Amulet,
intracardiac echocardiography, and transesophageal echocardiography from
their inception to July 12, 2019. Data extraction was performed using
standard form for the following: title, year of publication, sample size,
comorbid conditions, LAAO device, type of pre-procedural imaging,
intraprocedural imaging, and clinical outcomes including the following:
acute procedural success, fluoroscopy, and total procedure time and
complications. <br/>Result(s): A total of 42 relevant studies were
screened resulting in inclusion of 8 observational studies comparing TEE
and ICE in endocardial LAAO. Outcomes assessed including procedural
success (RR 1.00, 95% CI (0.97-1.03, p = 0.98)), complications (RR 0.77,
95% CI (0.52 to 1.15, p = 0.20)), fluoroscopy time (mean difference -
0.40, 95% CI (-3.12-2.32, p = 0.77)), and procedural time (mean difference
- 8.02, 95% CI (-22.81 to 6.76, p = 0.29)) were found to be similar
between both groups. <br/>Conclusion(s): While TEE is the gold standard
for perioperative imaging with LAAO, ICE is a feasible and safe
alternative that reduces exposure to general anesthesia and associated
potential risks.<br/>Copyright &#xa9; 2020, Springer Science+Business
Media, LLC, part of Springer Nature.

<140>
Accession Number
2010284327
Title
The International Society for Minimally Invasive Cardiothoracic Surgery
Expert Consensus Statement on Transcatheter and Surgical Aortic Valve
Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of
Randomized and Propensity-Matched Studies.
Source
Innovations: Technology and Techniques in Cardiothoracic and Vascular
Surgery. (no pagination), 2021. Date of Publication: 2021.
Author
Thourani V.H.; Edelman J.J.; Holmes S.D.; Nguyen T.C.; Carroll J.; Mack
M.J.; Kapadia S.; Tang G.H.L.; Kodali S.; Kaneko T.; Meduri C.U.; Forcillo
J.; Ferdinand F.D.; Fontana G.; Suwalski P.; Kiaii B.; Balkhy H.; Kempfert
J.; Cheung A.; Borger M.A.; Reardon M.; Leon M.B.; Popma J.J.; Ad N.
Institution
(Thourani) Department of Cardiovascular Surgery, Marcus Heart and Vascular
Center, Piedmont Heart and Vascular Institute, Atlanta, GA, United States
(Edelman) Department of Cardiac Surgery, Fiona Stanley Hospital,
University of Western Australia, Perth, Australia
(Holmes, Ad) Division of Cardiac Surgery, University of Maryland School of
Medicine, Baltimore, MD, United States
(Nguyen) Division of Adult Cardiothoracic Surgery, University of
California, San Francisco, CA, United States
(Carroll) Division of Cardiology, University of Colorado, Denver, CO,
United States
(Mack) Department of Cardiology, Baylor Health Care System, Heart Hospital
Baylor Plano, Dallas, TX, United States
(Kapadia) Department of Cardiology, Cleveland Clinic Foundation,
Cleveland, OH, United States
(Tang) Department of Cardiovascular Surgery, Mount Sinai Health System,
New York, NY, United States
(Kodali, Leon) Division of Cardiology, Columbia University Medical Center,
New York, NY, United States
(Kaneko) Division of Cardiac Surgery, Brigham and Women's Hospital,
Boston, MA, United States
(Meduri) Division of Cardiology, Marcus Heart and Vascular Center,
Piedmont Heart Institute, Atlanta, GA, United States
(Forcillo) Department of Cardiac Surgery, Centre Hospitalier de
l'Universite de Montreal (CHUM), Montreal, Canada
(Ferdinand) Department of Cardiothoracic Surgery, University of
Pittsburgh, School of Medicine $, UPMC Hamot Heart and Vascular Institute,
University of Pittsburgh Medical Center, PA, United States
(Fontana) Cardiovascular Institute, Los Robles Hospital and Medical
Center, Thousand Oaks, CA, United States
(Suwalski) Department of Cardiac Surgery, Central Clinical Hospital of the
Ministry of Interior and Administration, Centre of Postgraduate Medical
Education, Warsaw, Poland
(Kiaii) Cardiothoracic Surgery, UC Davis Medical Center, Sacramento, CA,
United States
(Balkhy) Section of Cardiac Surgery, University of Chicago Medicine, IL,
United States
(Kempfert) Department of Cardiac Surgery, German Heart Institute, Berlin,
Germany
(Cheung) Department of Cardiac Surgery, The University of British
Columbia, St. Paul's Hospital, Vancouver, Canada
(Borger) Department of Cardiac Surgery, Leipzig Heart Centre, Germany
(Reardon) Department of Cardiac Surgery, Methodist DeBakey Heart &
Vascular Center, Houston, TX, United States
(Popma) Department of Interventional Cardiology, Beth Israel Deaconess
Medical Center, Boston, MA, United States
(Ad) Cardiovascular Surgery, Adventist White Oak Medical Center, Silver
Spring, MD, United States
Publisher
SAGE Publications Ltd
Abstract
Objective: There is an increasing amount of evidence supporting use of
transcatheter aortic valve replacement (TAVR) for treatment of aortic
stenosis in patients at low or intermediate risk for surgical aortic valve
replacement (SAVR). TAVR is now approved for use in all patient cohorts.
Despite this, there remains debate about the relative efficacy of TAVR
compared with SAVR in lower-risk cohorts and various subgroups of
patients. We performed a systematic review and meta-analysis of randomized
controlled trials (RCTs) and propensity-matched trials to guide a
consensus among expert cardiologists and surgeons. <br/>Method(s): Studies
comparing TAVR and SAVR in low- and intermediate-risk patients were
identified by a thorough search of the major databases. Mortality, stroke,
and other perioperative outcomes were assessed at 30 days and 1 year.
<br/>Result(s): Early mortality was lower in TAVR compared to SAVR in
RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs
1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98,
I² = 0%). No difference in mortality between TAVR and SAVR was
identified in intermediate-risk patients at early or later time points.
Incidence of perioperative stroke in 3 low-risk RCTs was significantly
lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81,
I² = 0%). There was no difference in stroke for
intermediate-risk patients between TAVR and SAVR. The expert panel of
cardiologists and cardiac surgeons provided recommendations for TAVR and
SAVR in various clinical scenarios. <br/>Conclusion(s): In RCTs comparing
TAVR and SAVR in low-risk patients, early mortality and stroke were lower
in TAVR, but did not differ at 1 year. There was no difference in
mortality and stroke in intermediate-risk patients. The Multidisciplinary
Heart Team must consider individual patient characteristics and
preferences when recommending TAVR or SAVR. The decision must consider the
long-term management of each patient's aortic valve disease.<br/>Copyright
&#xa9; The Author(s) 2021.

<141>
Accession Number
2010836947
Title
Meta-Analysis Comparing the Safety and Efficacy of Single vs Dual
Antiplatelet Therapy in Post Transcatheter Aortic Valve Implantation
Patients.
Source
American Journal of Cardiology. (no pagination), 2021. Date of
Publication: 2021.
Author
Ullah W.; Zghouzi M.; Ahmad B.; Biswas S.; Zaher N.; Sattar Y.; Pacha
H.M.; Goldsweig A.M.; Velagapudi P.; Fichman D.L.; Prasad A.; Alraies M.C.
Institution
(Ullah) Abington Jefferson Health, Abington, Pennsylvnia
(Zghouzi, Ahmad, Zaher, Alraies) Detroit Medical Center, Heart Hospital,
Detroit, MI, United States
(Biswas) Rochester Regional Health, Rochester, NY, United States
(Sattar) Icahn school of medicine at Mount Sinai Elmhurst Hospital New
York, NY, United States
(Pacha) University of Texas Health Science Center, Houston, TX, United
States
(Goldsweig, Velagapudi) University of Nebraska Medical Center, Omaha, NE,
United States
(Fichman) Thomas Jefferson University Hospital, Philadelphia
(Prasad) University of Texas Health San Antonio Texas, TX, United States
Publisher
Elsevier Inc.
Abstract
The relative safety and efficacy of aspirin versus dual antiplatelet
therapy (DAPT; aspirin+clopidogrel) in patients who underwent
transcatheter aortic valve implantation (TAVI) and did not have a
long-term indication for oral anticoagulation remains controversial.
Digital databases were searched to identify relevant articles. The major
safety end point was bleeding, while the efficacy end points included
after-TAVI ischemic and thrombotic events. Data were analyzed using a
random effect model to calculate the pooled unadjusted odds ratio (OR) for
dichotomous outcomes. Eleven studies comprising 4805 patients (aspirin
2258, DAPT 2547) were included in the quantitative analysis. Patients
receiving aspirin-alone had significantly lower odds of all cause bleeding
(OR 0.41, 95% CI 0.29 to. 057, p <0.00001), major vascular bleeding (OR
0.51, 95% CI 0.34 to 0.77, p = 0.001), Valve Academic Research Consortium
2 (VARC-2) major bleeding (OR 0.50, 95% CI 0.30 to 0.83 p = 0.008), VARC-2
minor bleeding (OR 0.55, 95% CI 0.31 to 0.97, p = 0.04), transfusion
requirement (OR 0.39, 95%CI 0.15 to 0.0.98, p = 0.05) and major vascular
complications (OR0.41, 95% CI 0.26 to 0.66, p = 0.0002) compared with
after-TAVI patients receiving both aspirin and clopidogrel. These was no
significant difference in the odds of VARC-2 life threatening bleeding (OR
0.52, 95% CI 0.25 to 1.07, p = 0.08), prosthetic valve thrombosis (OR
1.17, 95% CI 0.22 to 6.30, p = 0.85), cardiac tamponade (OR 0.77, 95% CI
0.20 to 2.98, p = 0.70), conversion to open procedure (OR 1.99, 95 % CI
0.42 to 9.44, p = 0.39), MI (OR 0.79 95% CI 0.38 to 1.64, p = 0.52),
transient ischemic attack (TIA) (OR 0.89, 95% CI 0.12 to 6.44, p = 0.91),
major stroke (OR 0.68 95 % CI 0.43 to 1.08, p = 0.10), disabling stroke
(0R 1.01, 95% CI 0.41 to 2.48, p = 0.99), cardiovascular mortality (OR
0.81 95% CI 0.38 to 1.74, p = 0.59) and all-cause mortality (OR 0.86, 95%
CI 0.63 to 1.16, p = 0.31) between the 2 groups. In conclusion, after-TAVI
patients who received aspirin alone had lower bleeding events with no
significant differences in mortality and stroke rate compared with those
who received DAPT.<br/>Copyright &#xa9; 2021 Elsevier Inc.

<142>
Accession Number
2010760375
Title
A scoping review to identify competencies for transcatheter cardiovascular
procedures.
Source
Journal of Thoracic and Cardiovascular Surgery. (no pagination), 2021.
Date of Publication: 2021.
Author
Muller Moran H.R.; Maurice-Ventouris M.; Alharbi M.; Harley J.M.;
Lachapelle K.J.
Institution
(Muller Moran) Department of Surgery, University of Manitoba, Winnipeg,
MB, Canada
(Muller Moran, Maurice-Ventouris, Alharbi, Harley, Lachapelle) Department
of Surgery, McGill University, Montreal, QC, Canada
Publisher
Mosby Inc.
Abstract
Objectives: Transcatheter procedures are increasingly being recognized as
a priority for cardiac surgeons and cardiac surgery trainees. The optimal
method of teaching these procedures during residency training has not been
established. We used an evidence-based approach to systematically review
the literature and identify competencies to inform future paradigms of
transcatheter training in cardiac surgery. <br/>Method(s): A scoping
review was conducted to retrieve relevant literature on the performance of
transcatheter cardiovascular procedures, identify competencies required by
surgical residents learning to perform these procedures, and develop a
preliminary list of competencies for consideration during transcatheter
training. MEDLINE, Scopus, and ERIC were queried until April 1, 2020,
using a systematic search strategy. No limitations were placed on
publication date or type. <br/>Result(s): A total of 1456 sources of
evidence were retrieved. After deduplication and screening, there remained
33 that were included in the scoping review, published between 2006 and
2020. The distribution of publication types included 10 comparative
studies (30.3% of total), 8 societal statements (24.2% of total), 5
surveys and 5 opinion articles (each 15.2% of total), 2 editorials and 2
descriptions of a simulator (each 6.1% of total), and 1 narrative review
(3.0% of total). From these, a total of 400 items were identified and
organized into 97 competencies. <br/>Conclusion(s): Evidence on the
competencies required to perform transcatheter cardiovascular procedures
is available from a variety of sources. The identified competencies may be
a useful resource for developing curricula and teaching transcatheter
procedures to cardiac surgery residents.<br/>Copyright &#xa9; 2020 The
American Association for Thoracic Surgery

<143>
Accession Number
633876046
Title
Incidence and prevalence of pressure injury in adult cardiac patients
admitted to intensive care: A systematic review and meta-analysis.
Source
International journal of nursing studies. 114 (pp 103826), 2021. Date of
Publication: 01 Feb 2021.
Author
Fulbrook P.; Mbuzi V.; Miles S.
Institution
(Fulbrook) Nursing Research and Practice Development Centre, The Prince
Charles Hospital, Level 5 Clinical Sciences Building, Chermside, Brisbane,
Queensland 4032, Australia; School of Nursing, Midwifery and Paramedicine,
Australian Catholic University, Brisbane, Australia; Faculty of Health
Sciences, University of the Witwatersrand, Johannesburg, South Africa
(Mbuzi) Nursing Research and Practice Development Centre, The Prince
Charles Hospital, Level 5 Clinical Sciences Building, Chermside, Brisbane,
Queensland 4032, Australia; Adult Intensive Care Services, The Prince
Charles Hospital, Brisbane, Australia
(Miles) Nursing Research and Practice Development Centre, The Prince
Charles Hospital, Level 5 Clinical Sciences Building, Chermside, Brisbane,
Queensland 4032, Australia; School of Nursing, Midwifery and Paramedicine,
Australian Catholic University, Brisbane, Australia
Publisher
NLM (Medline)
Abstract
BACKGROUND: Pressure injury is recognised as an adverse event occurring in
healthcare settings. Patients in intensive care are at high risk of
developing a pressure injury. Cardiac patients are also among those at
higher risk. <br/>OBJECTIVE(S): To systematically assess the incidence and
prevalence of pressure injury in adult cardiac patients admitted to
intensive care. DESIGN: Systematic review and meta-analysis of incidence
and prevalence REVIEW METHODS: Articles published in English between 2009
and 2018, reporting pressure injury as a primary outcome were selected
based on inclusion criteria. Two authors assessed study bias and extracted
data, with a third reviewer as arbitrator. A random effects meta-analysis
was conducted. Sub-group meta-analyses were conducted to investigate
potential causes of heterogeneity. <br/>RESULT(S): Fifteen studies met the
criteria for inclusion in the systematic review, of which 14 were
incidence studies. Heterogeneity was significant and there was large
observed variance between studies. The 95% confidence interval of
cumulative incidence across all 14 studies, with an overall sample size of
6371, was 9.8-25.6%. In 11 studies that included all-stage pressure injury
the 95% confidence interval was 8.3-28.3%. In seven studies in which Stage
1 pressure injury was excluded, the 95% confidence interval was 5.8-22.7%.
In the single prevalence study included, which excluded Stage 1 pressure
injury, prevalence was 8.8%. <br/>CONCLUSION(S): The incidence of pressure
injury in cardiac intensive care patients was similar to that found in
general intensive care patients. However, our results suggest that the
incidence may be significantly higher in cardiac surgical patients
admitted to intensive care. There were significant differences across the
various studies in the ways in which data were collected and reported.
Further well-designed studies are required to better understand incidence
in this population, using standardised methods of data collection and
reporting.<br/>Copyright &#xa9; 2020. Published by Elsevier Ltd.

<144>
Accession Number
633507150
Title
Associations between mean arterial pressure during cardiopulmonary bypass
and biomarkers of cerebral injury in patients undergoing cardiac surgery:
secondary results from a randomized controlled trial.
Source
Interactive cardiovascular and thoracic surgery. 32 (2) (pp 229-235),
2021. Date of Publication: 22 Jan 2021.
Author
Wiberg S.; Holmgaard F.; Blennow K.; Nilsson J.C.; Kjaergaard J.; Wanscher
M.; Langkilde A.R.; Hassager C.; Rasmussen L.S.; Zetterberg H.; Vedel A.G.
Institution
(Wiberg, Kjaergaard, Hassager) Department of Cardiology, Rigshospitalet,
University of Copenhagen, Copenhagen, Denmark
(Holmgaard, Nilsson, Wanscher, Vedel) Department of Cardiothoracic
Anesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
(Blennow, Zetterberg) Department of Psychiatry and Neurochemistry,
Institute of Neuroscience and Physiology, Sahlgrenska Academy at the
University of Gothenburg, Molndal, Sweden
(Blennow, Zetterberg) Clinical Neurochemistry Laboratory, Sahlgrenska
University Hospital, Molndal, Sweden
(Langkilde) Department of Radiology, Rigshospitalet, University of
Copenhagen, Copenhagen, Denmark
(Hassager, Rasmussen) Department of Clinical Medicine, University of
Copenhagen, Copenhagen, Denmark
(Rasmussen) Department of Anesthesia, Center of Head and Orthopedics,
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
(Zetterberg) Department of Neurodegenerative Disease, UCL Institute of
Neurology, London, United Kingdom
(Zetterberg) UK Dementia Research Institute at UCL, London, United Kingdom
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Cardiac surgery is associated with risk of cerebral injury and
mean arterial pressure (MAP) during cardiopulmonary bypass (CPB) is
suggested to be associated with cerebral injury. The 'Perfusion Pressure
Cerebral Infarcts' (PPCI) trial randomized patients undergoing coronary
artery bypass grafting (CABG) and/or aortic valve replacement to a MAP of
40-50 or 70-80mmHg during CPB and found no difference in clinical or
imaging outcomes between the groups. We here present PPCI trial predefined
secondary end points, consisting of biomarkers of brain injury.
<br/>METHOD(S): Blood was collected from PPCI trial patients at baseline,
24 and 48h after induction of anaesthesia and at discharge from the
surgical ward. Blood was analysed for neuron-specific enolase, tau,
neurofilament light and the glial marker glial fibrillary acidic protein.
Linear mixed models were used to analyse differences in biomarker value
changes from baseline between the 2 MAP allocation groups. <br/>RESULT(S):
A total of 193 (98%) patients were included. We found no differences in
biomarker levels over time from baseline to discharge between the 2 MAP
allocation groups (PNSE = 0.14, PTau = 0.46, PNFL = 0.21, PGFAP = 0.13)
and the result did not change after adjustment for age, sex and type of
surgery. <br/>CONCLUSION(S): We found no significant differences in levels
of biomarkers of neurological injury in patients undergoing elective or
subacute CABG and/or aortic valve replacement randomized to either a
target MAP of 40-50mmHg or a target MAP of 70-80mmHg during
CBP.<br/>Copyright &#xa9; The Author(s) 2020. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<145>
Accession Number
633270737
Title
Different physiotherapy protocols after coronary artery bypass graft
surgery: A randomized controlled trial.
Source
Physiotherapy research international : the journal for researchers and
clinicians in physical therapy. 26 (1) (pp e1882), 2021. Date of
Publication: 01 Jan 2021.
Author
Ribeiro B.C.; Poca J.J.G.D.; Rocha A.M.C.; Cunha C.N.S.D.; Cunha K.D.C.;
Falcao L.F.M.; Torres D.D.C.; Rocha L.S.O.; Rocha R.S.B.
Institution
(Ribeiro, Poca, Rocha, Cunha, Cunha, Falcao, Rocha) Biological and Health
Sciences Center, Para State University, Belem, Brazil
(Torres) State Public Foundation Gaspar Vianna Clinical Hospital, Belem,
Brazil
(Rocha) Universitary Center of Para, Belem, Brazil
Publisher
NLM (Medline)
Abstract
BACKGROUND AND PURPOSE: The aim of this study was to investigate the
influence of different physiotherapy protocols on heart rate variability
(HRV) and hospital length of stay in older adults undergoing coronary
artery bypass graft (CABG). <br/>METHOD(S): Randomized controlled trial
with allocation and researcher blinding and intention-to-treat analysis.
Forty-eight patients undergoing CABG were randomly assigned to a control
group (CG), early mobilization group (EMG), or virtual reality group
(VRG). CG performed respiratory physiotherapy and metabolic exercises, the
EMG performed cycle ergometer exercises and ambulation, and the VRG
performed the same activities as the EMG, with the addition of two
Nintendo Wii games during 3 postoperative days. The variables of heart
rate variability on preoperative and fourth postoperative day, and time of
discharge of hospital was analyzed. <br/>RESULT(S): The VRG presented a
shorter hospital length of stay (p = 0.03). The CG showed a decline in HRV
from the preoperative period to fourth postoperative day on square root of
the mean of the squared differences between successive RR intervals (33.18
+/- 9.89-9.74 +/- 6.88, p < 0.05), standard deviation of all RR intervals
(25.48 +/- 7.50-15.23 +/- 11.27, p < 0.05), and dispersion of points
perpendicular to identity line (28.26 +/- 21.6-2.73 +/- 1.31, p < 0.05).
The EMG and VRG presented a higher cardiac autonomic modulation compared
to the CG (p < 0.05), with improved parasympathetic activity.
<br/>CONCLUSION(S): Different protocols of physiotherapy intervention
affected autonomic modulation of the heart rate and hospital length of
stay in patients undergoing CABG.<br/>Copyright &#xa9; 2020 John Wiley &
Sons Ltd.

<146>
Accession Number
634079237
Title
Coronary artery bypass surgery without blood transfusion; is it possible?.
Source
Nigerian journal of clinical practice. 24 (1) (pp 59-63), 2021. Date of
Publication: 01 Jan 2021.
Author
Aykut K.; Albayrak G.; Cetin Y.; Ciftci N.; Ciftci S.
Institution
(Aykut, Albayrak, Ciftci) Department of Cardiovascular Surgery, Izmir
Medicalpark Hospital, Izmir University of Economics, Izmir, Turkey
(Cetin) Department of Anesthesiology, Izmir Medicalpark Hospital, Izmir
University of Economics, Izmir, Turkey
(Ciftci) Department of Cardiovascular Surgery, Dokuz Eylul University,
Izmir, Turkey
Publisher
NLM (Medline)
Abstract
Background: Coronary artery bypass surgery is the most commonly performed
cardiac operation and approximately 40-70% of patients require a blood
transfusion despite improvements in cardiac surgical techniques. Some
preventive perfusion methods to avoid transfusions are described, such as
acute normovolemic hemodilution, retrograde autologous priming, and usage
of integrated arterial filter oxygenator. <br/>Aim(s): We combined these
three techniques (triple combination technique) to evaluate whether it is
possible to avoid blood transfusions in adult patients undergoing coronary
artery bypass surgery. <br/>Material(s) and Method(s): A total of 300
consecutive patients were included in this randomized controlled trial.
150 patients (Group 1) were operated with triple combination technique,
The other 150 patients (Group 2) were operated with standard
cardiopulmonary bypass technique. The two groups were compared in terms of
peroperative and postoperative blood product use. <br/>Result(s):
Ninety-two percent (92%) of the patients (Group 1) undergoing coronary
artery bypass surgery did not require any blood transfusion. Only 8% of
the patients required erythrocyte suspension or fresh frozen plasma
transfusion. In Group 2, 58% of patients required blood transfusions. The
difference between two groups was statistically significant (p < 0,05).
<br/>Conclusion(s): Triple combination technique is safe and
cost-effective in coronary artery bypass surgery. We think that most of
the patients could be operated without blood transfusion with this
technique.

<147>
Accession Number
2010588299
Title
Predictive value of early cardiac mri functional and geometric indexes on
adverse left ventricular remodelling in anterior STEMI patients. A report
from the CIRCUS study.
Source
Archives of Cardiovascular Diseases Supplements. Conference: Les 31emes
Journees Europeennes de la Societe Francaise de Cardiologie. 13 (1) (pp
9-10), 2021. Date of Publication: January 2021.
Author
Pezel T.; Besseyre Des Horts T.; Schaaf M.; Croisille P.; Biere L.; Garcia
Dorado D.; Jossan C.; Roubille F.; Tri Cung T.; Prunier F.; Elbaz M.; Amaz
C.; Derumeaux G.; De Poli F.; Hovassse T.; Gilard M.; Bergerot C.;
Thibault H.; Ovize M.; Mewton N.
Institution
(Pezel) Cardiologie, Hopital Lariboisiere, AP-HP, Paris
(Besseyre Des Horts, Schaaf, Jossan, Amaz, Bergerot, Thibault, Ovize,
Mewton) Lyon, Cardiovascular Hospital Louis Pradel, Clinical Investigation
Center and Heart Failure Department, INSERM 1407, Hospices Civils de Lyon,
Lyon
(Croisille) Saint-Etienne, University Hospital of Saint-Etienne,
Saint-Etienne, France
(Biere, Prunier) Angers, University Hospital of Angers, Angers, France
(Garcia Dorado) Hospital Universitari Vall d'Hebron & Research Institute,
Barcelona, Spain
(Roubille, Tri Cung) University Hospital of Montpellier, Cardiology
Division, UMR5203, UMR661, Montpellier
(Elbaz) Toulouse, University Hospital of Toulouse, hopital Rangeuil,
Toulouse, France
(Derumeaux) Creteil, University Paris-Est Creteil, Henri Mondor Hospital,
Creteil
(De Poli) Cardiology Division, Haguenau Hospital, Haguenau, France
(Hovassse) ICPS, Jacques Cartier institute, Massy
(Gilard) Brest, Brest University Hospital, Brest, France
Publisher
Elsevier Masson s.r.l.
Abstract
Introduction: Post-infarction adverse left ventricular (LV) remodelling is
strongly associated with subsequent heart failure events. The conicity
index, sphericity index and LV global functional index (LVGFI) are new LV
remodelling indexes assessed by cardiac magnetic resonance (CMR). The aim
of our study was to assess their predictive value on one-year adverse LV
remodelling in patients with anterior myocardial infarction.
<br/>Method(s): CMR studies were performed in 129 anterior ST-elevated
myocardial infarction (STEMI) patients (58 +/- 12 years, 78%men) from the
randomized CIRCUS trial (CMR sub-study) treated with the primary
percutaneous coronary intervention (PCI) and were followed for the
occurrence of major adverse cardiovascular events (MACE) (death or
hospitalization for heart failure). The conicity index, sphericity index,
LVGFI, infarct size (IS) and microvascular obstruction (MVO) were assessed
by CMR performed 5 +/- 2 days after coronary reperfusion. Adverse LV
remodelling was defined as an increase in LV end-diastolic volume >= 15%
by transthoracic echocardiography at 1 year. <br/>Result(s): Adverse LV
remodeling occurred in 27% of patients in one year. IS and MVO were
significantly predictive of adverse LV remodelling (OR = 1.03, CI 95%
[1.02-1.05], P < 0.001 and OR = 1.12, CI 95% [1.05-1.22] P < 0.001,
respectively). Among the newly tested indexes, only LVGFI was
significantly predictive of adverse LV remodelling (OR = 1.10, CI 95%
[1.03-1.16], P = 0.001). In multivariate analysis, only IS remained an
independent predictor of adverse LV remodeling at 1 year (OR = 1.05, CI
95% [1.02-1.08], P < 0.001). LVGFI and IS were associated with the
occurrence of MACE (OR = 1.21; CI 95% [1.08-1.37], P < 0.001 and OR =
1.02; CI 95% [1.00-1.04], P = 0.018 respectively). However, the conicity
and sphericity indexes were not associated with MACE (Fig. 1).
<br/>Conclusion(s): LVGFI was associated with adverse LV remodelling and
MACE at one year after anterior STEMI. However, this relationship and its
predictive value in on top of infarct size remain hypothesis-generating at
this stage. Further studies are needed to explore the relationship of all
these remodelling indices with adverse outcomes in larger populations of
MI patients.<br/>Copyright &#xa9; 2020

<148>
Accession Number
2005928580
Title
Low-intensity resistance training with moderate blood flow restriction
appears safe and increases skeletal muscle strength and size in
cardiovascular surgery patients: A pilot study.
Source
Journal of Clinical Medicine. 10 (3) (pp 1-13), 2021. Article Number: 547.
Date of Publication: 01 Feb 2021.
Author
Ogawa H.; Nakajima T.; Shibasaki I.; Nasuno T.; Kaneda H.; Katayanagi S.;
Ishizaka H.; Mizushima Y.; Uematsu A.; Yasuda T.; Yagi H.; Toyoda S.;
Hortobagyi T.; Mizushima T.; Inoue T.; Fukuda H.
Institution
(Ogawa, Shibasaki, Fukuda) Department of Cardiovascular Surgery, School of
Medicine, Dokkyo Medical University, Shimotsuga-gun, Tochigi 321-0293,
Japan
(Nakajima, Nasuno, Kaneda, Yagi, Toyoda, Inoue) Department of
Cardiovascular Medicine, School of Medicine, Dokkyo Medical University,
Shimotsuga-gun, Tochigi 321-0293, Japan
(Nakajima) Department of Medical KAATSU Training, Dokkyo Medical
University, Shimotsuga-gun, Tochigi 321-0293, Japan
(Katayanagi, Ishizaka, Mizushima, Mizushima) Department of Rehabilitation,
Dokkyo Medical University Hospital, Shimotsuga-gun, Tochigi 321-0293,
Japan
(Uematsu) Department of Health and Sport Sciences, Premedical Sciences,
Dokkyo Medical University, Shimotsuga-gun, Tochigi 321-0293, Japan
(Yasuda) School of Nursing, Seirei Christopher University, Shizuoka,
Hamamatsu 433-8558, Japan
(Hortobagyi) University Medical Center Groningen, University of Groningen,
Groningen, Groningen 9713 GZ, Netherlands
Publisher
MDPI AG
Abstract
We examined the safety and the effects of low-intensity resistance
training (RT) with moderate blood flow restriction (KAATSU RT) on muscle
strength and size in patients early after cardiac surgery. Cardiac
patients (age 69.6 +/- 12.6 years, n = 21, M = 18) were randomly assigned
to the control (n = 10) and the KAATSU RT group (n = 11). All patients had
received a standard aerobic cardiac rehabilitation program. The KAATSU RT
group additionally executed low-intensity leg extension and leg press
exercises with moderate blood flow restriction twice a week for 3 months.
RT-intensity and volume were increased gradually. We evaluated the
anterior mid-thigh thickness (MTH), skeletal muscle mass index (SMI),
handgrip strength, knee extensor strength, and walking speed at baseline,
5-7 days after cardiac surgery, and after 3 months. A physician monitored
the electrocardiogram, rate of perceived exertion, and the color of the
lower limbs during KAATSU RT. Creatine phosphokinase (CPK) and D-dimer
were measured at baseline and after 3 months. There were no side effects
during KAATSU RT. CPK and D-dimer were normal after 3 months. MTH, SMI,
walking speed, and knee extensor strength increased after 3 months with
KAATSU RT compared with baseline. Relatively low vs. high physical
functioning patients tended to increase physical function more after 3
months with KAATSU RT. Low-intensity KAATSU RT as an adjuvant to standard
cardiac rehabilitation can safely increase skeletal muscle strength and
size in cardiovascular surgery patients.<br/>Copyright &#xa9; 2021 by the
authors. Licensee MDPI, Basel, Switzerland.

<149>
Accession Number
2005826298
Title
Postoperative neurocognitive disorders in cardiac surgery: Investigating
the role of intraoperative hypotension. a systematic review.
Source
International Journal of Environmental Research and Public Health. 18 (2)
(pp 1-15), 2021. Article Number: 786. Date of Publication: 02 Jan 2021.
Author
Czok M.; Pluta M.P.; Putowski Z.; Krzych L.J.
Institution
(Czok, Pluta, Putowski, Krzych) Department of Anaesthesiology and
Intensive Care, Faculty of Medical Sciences in Katowice, Medical
University of Silesia, Katowice 40752, Poland
Publisher
MDPI AG
Abstract
Perioperative neurocognitive disorders remain a challenging obstacle in
patients after cardiac surgery, as they significantly contribute to
postoperative morbidity and mortality. Identifying the modifiable risk
factors and mechanisms for postoperative cognitive decline (POCD) and
delirium (POD) would be an important step forward in preventing such
adverse events and thus improving patients' outcome. Intraoperative
hypotension is frequently discussed as a potential risk factor for
neurocognitive decline, due to its significant impact on blood flow and
tissue perfusion, however the studies exploring its association with POCD
and POD are very heterogeneous and present divergent results. This review
demonstrates 13 studies found after structured systematic search strategy
and discusses the possible relationship between intraoperative hypotension
and postoperative neuropsychiatric dysfunction.<br/>Copyright &#xa9; 2021
by the authors. Licensee MDPI, Basel, Switzerland.

<150>
Accession Number
2010840200
Title
Full endoscopic surgery for thoracic pathology: an assessment of
supportive evidence.
Source
EFORT Open Reviews. 6 (1) (pp 51-60), 2021. Date of Publication: 2021.
Author
Gibson R.D.S.; Wagner R.; Gibson J.N.A.
Institution
(Gibson) Aberdeen Royal Infirmary, Aberdeen, United Kingdom
(Wagner) Ligamenta Spine Centre, Frankfurt am Main, Germany
(Gibson) The Royal College of Surgeons of Edinburgh, Edinburgh, United
Kingdom
Publisher
British Editorial Society of Bone and Joint Surgery
Abstract
In the last five years, surgeons have applied endoscopic transforaminal
surgical techniques mastered in the lumbar spine to the treatment of
thoracic pathology. The aim of this systematic review was to collate the
available literature to determine the place and efficacy of full
endoscopic approaches used in the treatment of thoracic disc prolapse and
stenosis. An electronic literature search of PubMed, Embase, the Cochrane
database and Google Scholar was performed as suggested by the Preferred
Reporting Items for Systematic Review and Meta-analysis statements.
Included were any full-text articles referring to full endoscopic thoracic
surgical procedures in any language. We identified 17 patient series, one
cohort study and 13 case reports with single or of up to three patients.
Although the majority included disc pathology, 11 papers related cord
compression in a proportion of cases to ossification of the ligamentum
flavum or posterior longitudinal ligament. Two studies described the
treatment of discitis and one reported the use of endoscopy for tumour
resection. Where reported, excellent or good outcomes were achieved for
full endoscopic procedures in a mean of 81% of patients (range 46-100%)
with a complication rate of 8% (range 0-15%), comparing favourably with
rates reported after open discectomy (anterior, posterolateral and
thoracoscopic) or by endoscopic tubular assisted approaches. Twenty-one of
the 31 author groups reported use of local anaesthesia plus sedation
rather than general anaesthesia, providing 'self-neuromonitoring' by
allowing patients to respond to cord and/or nerve stimuli.<br/>Copyright
&#xa9; 2021 The author(s)

<151>
Accession Number
2010881399
Title
Catheter-based treatment of the dissected ascending aorta: A systematic
review.
Source
European Journal of Cardio-thoracic Surgery. 59 (1) (pp 80-91), 2021. Date
of Publication: 01 Jan 2021.
Author
Wang C.; Von Segesser L.K.; Maisano F.; Ferrari E.
Institution
(Wang) Department of Cardiovascular Surgery, Jinling Hospital, Nanjing
University, School Medicine, Nanjing, China
(Von Segesser) Department of Surgery and Anesthesiology, Cardiovascular
Research Unit, University Hospital of Lausanne, Lausanne, Switzerland
(Maisano, Ferrari) Department of Cardiovascular Surgery, University
Hospital of Zurich, Zurich, Switzerland
(Ferrari) Department of Cardiac Surgery, Cardiocentro Ticino Foundation,
Lugano, Switzerland
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
Objectives: Type A aortic dissection requires immediate surgical repair.
Despite improvements in surgery and anaesthesia, there is still a
considerable risk when high-risk patients are concerned. Less invasive
endovascular treatments are under evaluation. We investigated the current
status of catheter-based treatment for type A aortic dissection with the
entry tear located in the ascending aorta. <br/>Method(s): A PubMed search
was supplemented by searching through bibliographies and key articles.
Demographics, risk score, stent graft detail, access route, mortality,
cause of death, complications, reinterventions and follow-up data were
extracted and analysed. <br/>Result(s): Thirty-one articles (7
retrospective reports; 24 case reports/series) were included in the study.
In total, 104 patients (mean age 71 +/- 14 years) received endovascular
treatment for acute (63) or chronic (41) type A dissection. A history of a
major cardiac or aortic operation was present in 29 patients. The mean
EuroSCORE II was 30 +/- 20 in 4 reports. A total of 114 stent grafts were
Implanted: 'off-the-shelf', 65/114; custom made, 12/114; and modified,
7/114. Hospital complications included intraprocedural conversion to open
surgery (2/104), stroke (2/104), coronary stenting (2/104), early endoleak
(9/104) and repeat aortic endovascular treatment for endoleak (5/104).
Hospital mortality was 10% (intraoperative death 2/104). Mean duration of
follow-up time was 21 +/- 21 months (range 1-81 months); follow-up data
were available for 86 patients: 10 patients died of non-aortic-related
causes; reintervention for aortic disease (endovascular repair or open
surgery) was performed in 8 patients. <br/>Conclusion(s): Catheter-based
ascending aorta repair for type A aortic dissection with the entry tear in
the ascending aorta can be considered in carefully selected high-risk
patients. Further analysis and specifically designed devices are
required.<br/>Copyright &#xa9; 2020 The Author(s). Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<152>
Accession Number
2010856767
Title
What are the endovascular options and outcomes for repair of ascending
aortic or aortic arch pathology?.
Source
Interactive Cardiovascular and Thoracic Surgery. 32 (1) (pp 106-110),
2021. Date of Publication: 01 Jan 2021.
Author
Sharma V.J.; Prakash M.; Lin Z.; Lo C.
Institution
(Sharma, Prakash, Lin, Lo) Department of Cardiothoracic Surgery, Waikato
District Health Board, Hamilton, New Zealand
(Sharma, Prakash, Lin, Lo) Waikato Institute of Surgery Education and
Research (WISER), Hamilton, New Zealand
Publisher
Oxford University Press
Abstract
A best evidence topic in cardiac surgery was written according to a
structured protocol. The question addressed was 'in patients with
ascending aortic or aortic arch disease what are the outcomes with
endovascular repair in terms of survival, complications and
reintervention?' Altogether 585 papers were found using the reported
search, of which 9 represented the best evidence to answer the clinical
question. The authors, journal, date and country of publication, patient
group studied, study type, relevant outcomes and results of these papers
are tabulated. We found that the endovascular operative techniques with
the greatest evidence were ascending aortic chimney grafts (AACs),
branched thoracic endovascular aortic repair (bTEVAR) aortic grafts and
fenestrated TEVAR (fTEVAR) aortic grafts. The best evidence available were
small case-series or retrospective cohort studies (n < 100), with 1
systematic review, at a short follow-up period (range 0-5 years).
Intraoperatively, these techniques have a high technical success rate
(84-100%). We found rates of endoleak comparable between AAC (7.4-16%) and
bTEVAR/fenestrated TEVAR (11.1-21.4%). Stroke rates are higher in bTEVAR
(3.1-42% vs 1-26% in AACs), attributed to more proximal pathology and
technically challenging procedures. Following the immediate postoperative
period, the 30-day mortality is 0-10.8% and patency is 97-100%. Stroke and
reintervention rates remain higher in the bTEVAR group (3.1-42.0% and
0.5-33.3%) compared to the AAC group (1.0-11.1% and 6.7-16.7%). The 3- and
5-year survival ranges from 59% to 90%, but is driven by non-aortic
pathology in a high-risk population; 3-year freedom from aortic death is
93-97%. Patency is 97-100% at up to 3 years, conformation and supra-aortic
occlusions thereafter remain unknown. We conclude that AACs, bTEVARs and
fenestrated TEVARs are safe endovascular options in high-risk elective
patients, with results comparable to open or hybrid repair. They remain
unverified in acute settings or in patients fit for open intervention.
<br/>Copyright &#xa9; 2020 The Author(s) 2020. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<153>
Accession Number
2010726952
Title
Time-to-treatment initiation of colchicine and cardiovascular outcomes
after myocardial infarction in the Colchicine Cardiovascular Outcomes
Trial (COLCOT).
Source
European Heart Journal. 41 (42) (pp 4092-4099), 2020. Date of Publication:
07 Nov 2020.
Author
Bouabdallaoui N.; Tardif J.-C.; Waters D.D.; Pinto F.J.; Maggioni A.P.;
Diaz R.; Berry C.; Koenig W.; Lopez-Sendon J.; Gamra H.; Kiwan G.S.;
Blondeau L.; Orfanos A.; Ibrahim R.; Gregoire J.C.; Dube M.-P.; Samuel M.;
Morel O.; Lim P.; Bertrand O.F.; Kouz S.; Guertin M.-C.; L'Allier P.L.;
Roubille F.
Institution
(Bouabdallaoui, Tardif, Ibrahim, Gregoire, Dube, Samuel, L'Allier)
Montreal Heart Institute, 5000 Belanger Street, Montreal, QC H1T 1C8,
Canada
(Bouabdallaoui, Tardif, Ibrahim, Gregoire, Dube, Samuel, L'Allier) Canada
and Universite de Montreal, Montreal, QC, Canada
(Waters) San Francisco General Hospital, CA, United States
(Pinto) Santa Maria University Hospital (CHULN), CAML, CCUL, Faculdade de
Medicina da Universidade de Lisboa, Lisboa, Portugal
(Maggioni) ANMCO Research Center, Firenze, Italy
(Diaz) Estudios Clinicos Latinoamerica, Rosario, Argentina
(Berry) University of Glasgow, NHS Glasgow Clinical Research Facility,
Glasgow, United Kingdom
(Koenig) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munich, Germany
(Koenig) DZHK (German Centre for Cardiovascular Research), partner site
Munich Heart Alliance, Munich, Germany
(Koenig) Institute of Epidemiology and Medical Biometry, University of
Ulm, Germany
(Lopez-Sendon) H La Paz, IdiPaz, UAM, Ciber-CV Madrid, Spain
(Gamra) Fattouma Bourguiba University Hospital, Monastir, Tunisia
(Kiwan) Bellevue Medical Center, Beirut, Lebanon
(Blondeau, Orfanos, Guertin) Montreal Health Innovations Coordinating
Center (MHICC), Montreal, Canada
(Morel) Division of Cardiovascular Medicine, Nouvel Hopital Civil,
Strasbourg University Hospital, Strasbourg, France
(Morel) INSERM (French National Institute of Health and Medical Research),
UMR 1260, Regenerative Nanomedicine, FMTS, Strasbourg, France
(Lim) Department of Cardiology, AP-HP, Hopital Universitaire Henri-Mondor,
INSERM U955, Universite Paris-Est Creteil, Creteil, France
(Bertrand) Institut de Cardiologie et Pneumologie de Quebec, Quebec City,
Canada
(Kouz) Centre Hospitalier Regional de Lanaudiere, Joliette, Canada
(Roubille) Universite de Montpellier, INSERM, CNRS, CHU de Montpellier,
France
Publisher
Oxford University Press
Abstract
Aims The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated
the benefits of targeting inflammation after myocardial infarction (MI).
We aimed to determine whether time-to-treatment initiation (TTI)
influences the beneficial impact of colchicine.
..........................................................................
..........................................................................
............................................... Methods In COLCOT,
patients were randomly assigned to receive colchicine or placebo within 30
days post-MI. Time-to- and results treatment initiation was defined as the
length of time between the index MI and the initiation of study
medication. The primary efficacy endpoint was a composite of
cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent
hospitalization for angina requiring coronary revascularization. The
relationship between endpoints and various TTI (<3, 4-7 and >8 days) was
examined using multivariable Cox regression models. Amongst the 4661
patients included in this analysis, there were 1193, 720, and 2748
patients, respectively, in the three TTI strata. After a median follow-up
of 22.7 months, there was a significant reduction in the incidence of the
primary endpoint for patients in whom colchicine was initiated < Day 3
compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals
(CI) 0.32-0.84], in contrast to patients in whom colchicine was initiated
between Days 4 and 7 (HR = 0.96, 95% CI 0.53-1.75) or > Day 8 (HR = 0.82,
95% CI 0.61-1.11). The beneficial effects of early initiation of
colchicine were also demonstrated for urgent hospitalization for angina
requiring revascularization (HR = 0.35), all coronary revascularization
(HR = 0.63), and the composite of cardiovascular death, resuscitated
cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05).
..........................................................................
..........................................................................
............................................... Conclusion Patients
benefit from early, in-hospital initiation of colchicine after
MI.<br/>Copyright VC The Author(s) 2020. Published by Oxford University
Press on behalf of the European Society of Cardiology.

<154>
Accession Number
2010856496
Title
Identifying critically important cardiovascular outcomes for trials in
hemodialysis: An international survey with patients, caregivers and health
professionals.
Source
Nephrology Dialysis Transplantation. 35 (10) (pp 1761-1769), 2020. Date of
Publication: 01 Oct 2020.
Author
O'Lone E.; Howell M.; Viecelli A.K.; Craig J.C.; Tong A.; Sautenet B.;
Herrington W.G.; Herzog C.A.; Jafar T.H.; Jardine M.; Krane V.; Levin A.;
Malyszko J.; Rocco M.V.; Strippoli G.; Tonelli M.; Wang A.Y.-M.; Wanner
C.; Zannad F.; Winkelmayer W.C.; Wheeler D.C.
Institution
(O'Lone, Howell, Tong, Strippoli) Sydney School of Public Health,
University of Sydney, Sydney, NSW, Australia
(O'Lone, Howell, Tong, Strippoli) Centre for Kidney Research, Children's
Hospital at Westmead, Sydney, NSW, Australia
(Viecelli) Department of Nephrology, Princess Alexandra Hospital,
Brisbane, QLD, Australia
(Viecelli) Australasian Kidney Trials Network, University of Queensland,
Brisbane, QLD, Australia
(Craig) College of Medicine and Health, Flinders University, Adelaide, SA,
Australia
(Sautenet) Department of Nephrology and Clinical Immunology, Tours
University, Tours, France
(Sautenet) Department of Nephrology-Hypertension, Dialysis, Renal
Transplantation, Tours Hospital, Tours, France
(Sautenet) INSERM U1246, Tours, France
(Herrington) Nuffield Department of Population Health, University of
Oxford, Medical Research Council Population Health Research Unit, Clinical
Trial Service Unit, Epidemiological Studies Unit, Oxford, United Kingdom
(Herzog) Department of Medicine, Division of Cardiology, Hennepin County
Medical Center, University of Minnesota, Minneapolis, MN, United States
(Jafar) Program in Health Services and Systems Research, Duke-NUS Graduate
Medical School, Singapore, Singapore
(Jafar) Department of Renal Medicine, Singapore General Hospital,
Singapore, Singapore
(Jafar) Department of Medicine, Section of Nephrology, Aga Khan
University, Karachi, Pakistan
(Jardine) George Institute for Global Health, Sydney, NSW, Australia
(Jardine) Concord Repatriation General Hospital, Sydney, NSW, Australia
(Krane, Wanner) Department of Medicine I, Division of Nephrology,
University Hospital, Wurzburg, Germany
(Levin) Division of Nephrology, University of British Columbia, Vancouver,
BC, Canada
(Malyszko) Department of Nephrology, Dialysis and Internal Medicine,
Warsaw Medical University, Warsaw, Poland
(Rocco) Wake Forest School of Medicine, Section on Nephrology,
Winston-Salem, NC, United States
(Strippoli) Department of Emergency and Organ Transplantation, University
of Bari, Bari, Italy
(Strippoli) Medical Scientific Office, Diaverum Sweden AB, Lund, Sweden
(Strippoli) Diaverum Academy, Bari, Italy
(Tonelli) Department of Medicine, Division of Nephrology, University of
Calgary, Calgary, AB, Canada
(Wang) Department of Medicine, Queen Mary Hospital, University of Hong
Kong, Hong Kong, Hong Kong
(Zannad) Universite de Lorraine, Inserm CIC 1433, INI-CRCT, CHU, Nancy,
France
(Winkelmayer) Selzman Institute for Kidney Health, Section of Nephrology,
Baylor College of Medicine, Houston, TX, United States
(Wheeler) Department of Renal Medicine, University College London, London,
United Kingdom
Publisher
Oxford University Press
Abstract
Background. Cardiovascular disease (CVD) is a major contributor to
morbidity and mortality in people on hemodialysis (HD). Cardiovascular
outcomes are reported infrequently and inconsistently across trials in HD.
This study aimed to identify the priorities of patients/caregivers and
health professionals (HPs) for CVD outcomes to be incorporated into a core
outcome set reported in all HD trials. Methods. In an international online
survey, participants rated the absolute importance of 10 cardiovascular
outcomes (derived from a systematic review) on a 9-point Likert scale,
with 7-9 being critically important. The relative importance was
determined using a best-worst scale. Likert means, medians and proportions
and best-worst preference scores were calculated for each outcome.
Comments were thematically analyzed. Results. Participants included 127
(19%) patients/caregivers and 549 (81%) HPs from 53 countries, of whom 530
(78%) completed the survey in English and 146 (22%) in Chinese. All but
one cardiovascular outcome ('valve replacement') was rated as critically
important (Likert 7-9) by all participants; 'sudden cardiac death', 'heart
attack', 'stroke' and 'heart failure' were all rated at the top by
patients/caregivers (median Likert score 9). Patients/caregivers ranked
the same four outcomes as the most important outcomes with mean preference
scores of 6.2 (95%<br/>Copyright &#xa9; The Author(s) 2020. Published by
Oxford University Press on behalf of ERA-EDTA. All rights reserved.

<155>
Accession Number
2010854932
Title
Beneficial effect of left atrial appendage closure during cardiac surgery:
A meta-analysis of 280 585 patients.
Source
European Journal of Cardio-thoracic Surgery. 57 (2) (pp 252-262), 2020.
Date of Publication: 01 Feb 2020.
Author
Gutierrez E.M.; Castano M.; Gualis J.; Martinez-Comendador J.M.; Maiorano
P.; Castillo L.; Laguna G.
Institution
(Castano, Gualis, Maiorano, Castillo, Laguna) Servicio de Cirugia
Cardiaca, Hospital Universitario de Leon - CAULE, Leon, Spain
(Martinez-Comendador) Servicio de Cirugia Cardiaca, Complexo Hospitalario
Universitario A Coruna (CHUAC), A Coruna, Spain
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
In non-rheumatic atrial fibrillation (AF), left atrial appendage (LAA) is
thought to be the source of embolism in 90% of the strokes. Thus, as
recent clinical trials have shown the non-inferiority of percutaneous LAA
closure (LAAc) in comparison to medical treatment, and despite a IIb
recommendation in the latest guidelines for concomitant surgical LAAc, we
sought to investigate the beneficial effect of LAAc in the surgical
population. A meta-analysis model was performed comparing studies
including any cardiac surgery with or without concomitant surgical LAAc
reporting stoke/embolic events and/or mortality, from inception to January
2019. Twenty-two studies (280 585 patients) were included in the model.
Stroke/embolic events both in the perioperative period [relative risk (RR)
0.66, 95% confidence interval (CI) 0.53-0.82; P = 0.0001] and during
follow-up of >2 years (RR 0.67, 95% CI 0.51-0.89; P < 0.005) were
significantly reduced in patients who underwent surgical LAAc (RR 0.71,
95% CI 0.58-0.87; P = 0.001). Regarding the rate of preoperative AF, LAAc
showed protective effect against stroke/embolic events in studies with
>70% preoperative AF (RR 0.64, 95% CI 0.53-0.77; P < 0.00001) but no
benefit in the studies with <30% of preoperative AF (RR 0.77, 95% CI
0.46-1.28; P = 0.31). Postoperative mortality was also significantly lower
in surgical patients with LAAc at the mid- and long-term follow-up. (RR
0.72, 95% CI 0.67-0.78; P < 0.00001; I² = 0%). Based on these
findings, concomitant surgical LAAc is associated with lower rates of
embolic events and stroke in the postoperative period in patients with
preoperative AF and also improves postoperative mortality in the mid- and
long-term follow-up.<br/>Copyright &#xa9; The Author(s) 2019. Published by
Oxford University Press on behalf of the European Association for
Cardio-Thoracic Surgery. All rights reserved.

<156>
Accession Number
2005922697
Title
Effect of buteyko breathing technique and incentive spirometer on breath
control pause in post cardiac surgery patients.
Source
Rawal Medical Journal. 45 (4) (pp 970-973), 2020. Date of Publication:
October-December 2020.
Author
Afshan N.; Ahmad S.; Shahid S.; Fatima A.
Institution
(Afshan, Ahmad, Shahid, Fatima) University Institute of Physical Therapy,
The University of lahore, Lahore, Pakistan
Publisher
Pakistan Medical Association
Abstract
Objective: To compare the effects of Buteyko breathing technique and
Incentive Spirometer on breath control pause in post-cardiac surgery
patients. Methodology: This Randomized Controlled Trial included 48
postoperative cardiac surgery patients, Data were collected using
Purposive Sampling technique from the Sharif Medical City Hospital by a
Questionnaire. The study was completed in 9 months and data were analyzed
with SPSS software. <br/>Result(s): Out of 48 patients, 26(54.2%) were
male and 22(45.8%) female and 8 were drop-outs. They were divided in two
groups of 20 in each group; Group A (Buteyko breathing technique) and
Group B Incentive Spirometer. Pre-Treatment Control Pause Group A had
13(65%) sereiosly sick patients and 07(35%) were sick patients with other
complication and on medication and in Group B, 06(30%) were seriously sick
and 14(70%) were sick patients with other complication and on medication.
Post-Treatment Control Pause Group A had 5(25%) patients in poor health
without serious organic disease and 15(75%) were in good health. In Group
B, 2(10%) patients had poor health without serious organic disease and
18(90%) had good health (p=0.01). <br/>Conclusion(s): There was
significant variation in control pause (breath holding time) of
post-cardiac surgery patients after using Incentive Spirometer when
compared to the Buteyko breathing technique. Incentive spirometer was
better than Buteyko breathing technique for improving control pause in
Post-operative cardiac patients.<br/>Copyright &#xa9; 2020, Pakistan
Medical Association. All rights reserved.

<157>
Accession Number
634101423
Title
Comparison of different size left-sided double-lumen tubes for thoracic
surgery.
Source
Annals of Cardiac Anaesthesia. 24 (1) (pp 42-46), 2021. Date of
Publication: January-March 2021.
Author
Nguyen R.D.; Kurnutala L.N.; Tucci M.A.; Hierlmeier B.J.
Institution
(Nguyen, Kurnutala, Tucci, Hierlmeier) Department of Anesthesiology,
University of Mississippi Medical Center, Jackson, MS 39216, United States
Publisher
Wolters Kluwer Medknow Publications
Abstract
Study Objective: The aim of this study is to see if there are any clinical
differences between using 35 F DLT for all patients versus using patient
height regardless of gender to estimate appropriate DLT size.
<br/>Design(s): Prospective randomized study. <br/>Setting(s): University
Hospital. <br/>Patient(s): 50 patients age >=18 years, undergoing lung or
esophageal surgery requiring OLV. <br/>Intervention(s): Patients
randomized to two groups (group-35F, group -DLT based on height).
<br/>Measurements and Main Results: Data collected include demographics,
ASA status, airway assessment, number of intubation attempts,
Cormack-Lehane grade, number of times DLT repositioned, incidence of sore
throat, oxygen saturation at induction and oxygen saturation at 5 minutes
and 10 minutes after OLV. There was no statistically significant
difference in demographics, ASA classification, Mallampati score, number
of intubation attempts, Cormack-Lehane grade, number of times DLT was
repositioned, and incidence of sore throat. In height based DLT group the
odds were higher for the incidence of sore throat in 37-41 F group. Oxygen
saturation at induction, 5 minutes and 10 minutes after OLV are not
statistically significant between the two groups. <br/>Conclusion(s): Our
findings suggest that the majority of patients receive unnecessarily large
DLTs for thoracic surgery, which not only makes intubation inherently more
difficult but also increases their risk of postoperative sore
throat.<br/>Copyright &#xa9; 2021 Wolters Kluwer Medknow Publications. All
rights reserved.

<158>
Accession Number
634101421
Title
Comparison of ringer's lactate and plasmalyte-a as cardiopulmonary bypass
prime for bypass associated acidosis in valve replacement surgeries.
Source
Annals of Cardiac Anaesthesia. 24 (1) (pp 36-41), 2021. Date of
Publication: January-March 2021.
Author
Surabhi S.; Kumar M.
Institution
(Surabhi, Kumar) Department of Anaesthesia and Intensive Care, Vardhman
Mahavir Medical College and Safdarjung Hospital, New Delhi, India
Publisher
Wolters Kluwer Medknow Publications
Abstract
Introduction: A wide range of acid base fluctuations are seen during
Cardiopulmonary bypass (CPB) and the development of metabolic acidosis is
well recognized. We conducted a study tocompare the metabolic effects of
Ringer lactate and Plasmalyte-A as CPB prime in causing bypass associated
acidosis in valve replacement surgeries. <br/>Method(s): We performed a
prospective, randomized controlled study on a total of 80 adult patients
undergoing CPB for valvular heart surgeries. The patients were randomized
into two groups: Group I (Ringer Lactate) and Group II (Plasmalyte-A).
Arterial blood samples were taken before initiating CPB, 30 minutes after
starting CPB, then every half hourly till termination of CPB and after
half an hour stay in the ICU post operatively to analyze primarily H+
ions, bicarbonates, lactate and strong ion difference. Results and
Discussion: The results were analyzed in a quantitative manner. In Ringer
Lactate group, during CPB, there was reduction in pH from 7.428 +/- 0.029
at T1 to 7.335 +/- 0.06 (P < 0.01) and 7.358 +/- 0.06 (P < 0.01) at T2 and
T3 respectively. Mean bicarbonates decreased in Ringer Lactate group
during CPB from 24.28 +/- 1.65 mEq/L at T1 to 20.98 +/- 2.97 mEq/L at T2
(P < 0.01). In Plasmalyte-A group, mean pH, bicarbonate, strong ion
difference (SID) were comparable at all time intervals (P > 0.05). In
Ringer Lactate group, maximum surge in mean blood lactate levels was seen
from 0.85 +/- 0.35 mmol/l at T1 to 4.29 +/- 1.78 mmol/L (P < 0.01) and
4.17 +/- 1.28 mmol/L (P < 0.01) at T2 and T3, respectively. Such surge was
not seen in Plasmalyte-A group. The mean SID decreased during the CPB in
Ringer Lactate group from 41.102 mEq/L at T1 to 35.66 mEq/L (P = 0.033) at
T2 implying metabolic acidosis. Numbered patients having hypotension and
arrhythmias were also higher in Ringer Lactate group again indicating
higher acidosis. <br/>Conclusion(s): The different composition of
Plasmalyte-A and Ringer Lactate have different metabolic implications for
patients undergoing cardiac surgery. Patients who received Plasmalyte-A as
cardiopulmonary bypass prime developed less metabolic acidosis. Hence we
conclude that Plasmalyte-A is the preferred cardiopulmonary bypass prime
in adult patients undergoing valve replacement surgeries.<br/>Copyright
&#xa9; 2021 Wolters Kluwer Medknow Publications. All rights reserved.

<159>
Accession Number
634101417
Title
The synergistic effect of tranexamic acid and ethamsylate combination on
blood loss in pediatric cardiac surgery.
Source
Annals of Cardiac Anaesthesia. 24 (1) (pp 17-23), 2021. Date of
Publication: January-March 2021.
Author
Abd El Baser I.I.; ElBendary H.M.; ElDerie A.
Institution
(Abd El Baser, ElBendary) Departments of Anesthesia and Surgical Intensive
Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt
(ElDerie) Departments of Cardiothoracic Surgery, Faculty of Medicine,
Mansoura University, Mansoura, Egypt
Publisher
Wolters Kluwer Medknow Publications
Abstract
Background: Pediatric patients are at risk for bleeding after cardiac
surgery. Administration of antifibrinolytic agents reduces postoperative
blood loss. <br/>Objective(s): Evaluation of the efficacy of combined
administration of tranexamic acid (TXA) and ethamsylate in the reduction
of postoperative blood loss in pediatric cardiac surgery. <br/>Method(s):
This prospective randomized study included 126 children submitted for
cardiac surgery, and they were allocated into three groups: Control group
(n = 42); TXA group (n = 42):- received only TXA; and combined ethamsylate
TXA group (n = 42):- received a combination of TXA and ethamsylate. The
main collected data included sternal closure time, the needs for
intraoperative transfusion of blood and its products, the total amount of
blood loss, and the amount of the whole blood and its products transfused
to the patients in the first 24 postoperative hours. <br/>Result(s): Blood
loss volume in the first 24 postoperative hours was significantly smaller
in combined group than the TXA and control groups and was significantly
smaller in the TXA group than the control group. The sternal closure time
was significantly shorter in the combined group than the other 2 groups
and significantly shorter in TXA than the control group. The amount of
whole blood transfused to patients in the combined group during surgery
and in the first postoperative 24 h was significantly smaller than the
other 2 groups and smaller in TXA group than the control group during
surgery. <br/>Conclusion(s): Combined administration of ethamsylate and
TXA in pediatric cardiac surgery was more effective in reducing
postoperative blood loss and whole blood transfusion requirements than the
administration of TXA alone.<br/>Copyright &#xa9; 2021 Wolters Kluwer
Medknow Publications. All rights reserved.

<160>
Accession Number
634096179
Title
Corrigendum to: Clinical and Conceptual Approaches to interpreting the
findings of Systematic Review and Meta-Analysis of Mortality after
drug-eluting stents vs. coronary artery bypass grafting for left main
coronary artery disease.
Source
European heart journal. (no pagination), 2021. Date of Publication: 17 Jan
2021.
Author
Anonymous
Publisher
NLM (Medline)

<161>
Accession Number
634091186
Title
Restrictive Transfusion Strategy after Cardiac Surgery.
Source
Anesthesiology. (no pagination), 2021. Date of Publication: 21 Jan 2021.
Author
Zeroual N.; Blin C.; Saour M.; David H.; Aouinti S.; Picot M.-C.; Colson
P.H.; Gaudard P.
Publisher
NLM (Medline)
Abstract
BACKGROUND: Recent guidelines on transfusion in cardiac surgery suggest
that hemoglobin might not be the only criterion to trigger transfusion.
Central venous oxygen saturation (Svo2), which is related to the balance
between tissue oxygen delivery and consumption, may help the decision
process of transfusion. We designed a randomized study to test whether
central Svo2-guided transfusion could reduce transfusion incidence after
cardiac surgery. <br/>METHOD(S): This single center, single-blinded,
randomized controlled trial was conducted on adult patients after cardiac
surgery in the intensive care unit (ICU) of a tertiary university
hospital. Patients were screened preoperatively and were assigned randomly
to two study groups (control or Svo2) if they developed anemia (hemoglobin
less than 9g/dl), without active bleeding, during their ICU stay. Patients
were transfused at each anemia episode during their ICU stay except the
Svo2 patients who were transfused only if the pretransfusion central Svo2
was less than or equal to 65%. The primary outcome was the proportion of
patients transfused in the ICU. The main secondary endpoints were (1)
number of erythrocyte units transfused in the ICU and at study discharge,
and (2) the proportion of patients transfused at study discharge.
<br/>RESULT(S): Among 484 screened patients, 100 were randomized, with 50
in each group. All control patients were transfused in the ICU with a
total of 94 transfused erythrocyte units. In the Svo2 group, 34 (68%)
patients were transfused (odds ratio, 0.031 [95% CI, 0 to 0.153]; P <
0.001 vs. controls), with a total of 65 erythrocyte units. At study
discharge, eight patients of the Svo2 group remained nontransfused and the
cumulative count of erythrocyte units was 96 in the Svo2 group and 126 in
the control group. <br/>CONCLUSION(S): A restrictive transfusion strategy
adjusted with central Svo2 may allow a significant reduction in the
incidence of transfusion.<br/>Copyright &#xa9; 2021, the American Society
of Anesthesiologists, Inc. All Rights Reserved.

<162>
Accession Number
634090445
Title
Modified ultrafiltration reduces postoperative blood loss and transfusions
in adult cardiac surgery: a meta-analysis of randomized controlled trials.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2021.
Date of Publication: 20 Jan 2021.
Author
Low Z.K.; Gao F.; Sin K.Y.K.; Yap K.H.
Institution
(Low, Yap) Department of Cardiothoracic Surgery, KK Women's and Children's
Hospital, Singapore
(Gao) Department of Biostatistics, National Heart Centre Singapore,
Singapore
(Gao) Duke-NUS Medical School, Singapore
(Sin, Yap) Department of Cardiothoracic Surgery, National Heart Centre
Singapore, Singapore
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Cardiopulmonary bypass in cardiac surgery has been associated
with several deleterious effects including haemodilution and systemic
inflammation. Modified ultrafiltration (MUF) has been well established in
paediatric cardiac surgery in counteracting postperfusion syndrome.
However, MUF is less commonly used in adult cardiac surgery. In this
meta-analysis, we compared clinical outcomes in adult patients who
underwent cardiopulmonary bypass with and without MUF. <br/>METHOD(S):
Electronic searches were performed using Pubmed, Ovid Medline, EMBASE and
the Cochrane Library until April 2020. Selection criteria were randomized
studies of adult cardiac surgery patients comparing MUF versus no MUF.
Primary outcomes were postoperative mortality, haematocrit, blood
transfusion, chest tube drainage, duration of intensive care unit (ICU)
stay and duration of mechanical ventilation. <br/>RESULT(S): Thirteen
randomized controlled trials were included, comprising 626 patients in the
MUF group, and 610 patients in the control (no-MUF) group. There was a
significantly improved postoperative haematocrit [mean difference 2.70,
95% confidence interval (CI) 0.68-4.73, P=0.009], lower chest tube
drainage (mean difference -105 ml, 95% CI -202 to -7 ml, P=0.032), lower
postoperative blood transfusion rate (mean difference -0.73 units, 95% CI
-0.98 to -0.47 units, P<0.0001) and shorter duration of ICU stay (mean
difference -0.13days, 95% CI -0.27 to -0.00days, P=0.048) in the MUF
group. There was no difference in ventilation time (mean difference
-0.47h, 95% CI -2.05 to 1.12h, P=0.56) or mortality rates (odds ratio
0.62, 95% CI 0.28-1.33, P=0.22). There were no reported complications
associated with MUF. <br/>CONCLUSION(S): MUF is a safe and feasible option
in adult cardiac patients, with significant benefits including improved
postoperative haematocrit, as well as reduced postoperative chest tube
bleeding, transfusion requirements and duration of ICU stay.<br/>Copyright
&#xa9; The Author(s) 2021. Published by Oxford University Press on behalf
of the European Association for Cardio-Thoracic Surgery. All rights
reserved.

<163>
Accession Number
634088678
Title
Free Hemoglobin Ratio as a Novel Biomarker of Acute Kidney Injury After
On-Pump Cardiac Surgery: Secondary Analysis of a Randomized Controlled
Trial.
Source
Anesthesia and analgesia. (no pagination), 2021. Date of Publication: 21
Jan 2021.
Author
Hu J.; Rezoagli E.; Zadek F.; Bittner E.A.; Lei C.; Berra L.
Institution
(Hu) From the Department of Critical Care Medicine, Chinese PLA General
Hospital, Beijing, China
(Hu, Bittner, Berra) Department of Anesthesia, Critical Care and Pain
Medicine, Massachusetts General Hospital, Boston, MA
(Rezoagli) School of Medicine and Surgery, University of Milan-Bicocca,
Monza, Italy
(Zadek) Department of Pathophysiology and Transplantation, University of
Milan, Milan, Italy
(Lei) Department of Anesthesiology and Perioperative Medicine, Xijing
Hospital, Fourth Military Medical University, Xi'an, China
Publisher
NLM (Medline)
Abstract
BACKGROUND: Cardiac surgery with cardiopulmonary bypass (CPB) is
associated with a high risk of postoperative acute kidney injury (AKI).
Due to limitations of current diagnostic strategies, we sought to
determine whether free hemoglobin (fHb) ratio (ie, levels of fHb at the
end of CPB divided by baseline fHb) could predict AKI after on-pump
cardiac surgery. <br/>METHOD(S): This is a secondary analysis of a
randomized controlled trial comparing the effect of nitric oxide
(intervention) versus nitrogen (control) on AKI after cardiac surgery
(NCT01802619). A total of 110 adult patients in the control arm were
included. First, we determined whether fHb ratio was associated with AKI
via multivariable analysis. Second, we verified whether fHb ratio could
predict AKI and incorporation of fHb ratio could improve predictive
performance at an early stage, compared with prediction using urinary
biomarkers alone. We conducted restricted cubic spline in logistic
regression for model development. We determined the predictive
performance, including area under the receiver-operating-characteristics
curve (AUC) and calibration (calibration plot and accuracy, ie, number of
correct predictions divided by total number of predictions). We also used
AUC test, likelihood ratio test, and net reclassification index (NRI) to
compare the predictive performance between competing models (ie, fHb ratio
versus neutrophil gelatinase-associated lipocalin [NGAL],
N-acetyl-beta-d-glucosaminidase [NAG], and kidney injury molecule-1
[KIM-1], respectively, and incorporation of fHb ratio with NGAL, NAG, and
KIM-1 versus urinary biomarkers alone), if applicable. <br/>RESULT(S):
Data stratified by median fHb ratio showed that subjects with an fHb ratio
>2.23 presented higher incidence of AKI (80.0% vs 49.1%; P = .001), more
need of renal replacement therapy (10.9% vs 0%; P = .036), and higher
in-hospital mortality (10.9% vs 0%; P = .036) than subjects with an fHb
ratio <=2.23. fHb ratio was associated with AKI after adjustment for
preestablished factors. fHb ratio outperformed urinary biomarkers with the
highest AUC of 0.704 (95% confidence interval [CI], 0.592-0.804) and
accuracy of 0.714 (95% CI, 0.579-0.804). Incorporation of fHb ratio
achieved better discrimination (AUC test, P = .012), calibration
(likelihood ratio test, P < .001; accuracy, 0.740 [95% CI, 0.617-0.832] vs
0.632 [95% CI, 0.477-0.748]), and significant prediction increment (NRI,
0.638; 95% CI, 0.269-1.008; P < .001) at an early stage, compared with
prediction using urinary biomarkers alone. <br/>CONCLUSION(S): Results
from this exploratory, hypothesis-generating retrospective, observational
study shows that fHb ratio at the end of CPB might be used as a novel,
widely applicable biomarker for AKI. The use of fHb ratio might help for
an early detection of AKI, compared with prediction based only on urinary
biomarkers.<br/>Copyright &#xa9; 2021 International Anesthesia Research
Society.

<164>
Accession Number
2010596248
Title
Single Versus Dual Antiplatelet Therapy Following TAVR: A Systematic
Review and Meta-Analysis of Randomized Controlled Trials.
Source
JACC: Cardiovascular Interventions. 14 (2) (pp 234-236), 2021. Date of
Publication: 25 Jan 2021.
Author
Guedeney P.; Sorrentino S.; Mesnier J.; De Rosa S.; Indolfi C.; Zeitouni
M.; Kerneis M.; Silvain J.; Montalescot G.; Collet J.-P.
Publisher
Elsevier Inc.

<165>
[Use Link to view the full text]
Accession Number
2010025805
Title
Angiography- vs. physiologyguided complete revascularization in patients
with ST-elevationmyocardial infarction andmultivessel disease: Who is the
better gatekeeper in this setting? A meta-analysis of randomized
controlled trials.
Source
European Heart Journal - Quality of Care and Clinical Outcomes. 6 (3) (pp
199-200), 2020. Date of Publication: 01 Jul 2020.
Author
Gallone G.; Angelini F.; Fortuni F.; Gnecchi M.; De Filippo O.; Baldetti
L.; Giannini F.; Colombo A.; D'Ascenzo F.; De Ferrari G.M.
Institution
(Gallone, Angelini, De Filippo, D'Ascenzo, De Ferrari) Division of
Cardiology, Department of Internal Medicine, Citta della Salute e della
Scienza, Corso Bramante 88/90, Turino 10126, Italy
(Fortuni, Gnecchi) Coronary Care Unit, Laboratory of Clinical and
Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia,
Italy
(Fortuni, Gnecchi) Unit of Cardiology, Department of Molecular Medicine,
University of Pavia, Pavia, Italy
(Baldetti) Unit of Cardiovascular Interventions, IRCCS San Raffaele
Scientific Institute, Milan, Italy
(Giannini, Colombo) Interventional Cardiology Unit, GVM Care & Research
Maria Cecilia Hospital, Cotignola, Italy
Publisher
Oxford University Press

<166>
Accession Number
2005790827
Title
Donor-recipient matching in heart transplantation.
Source
Open Cardiovascular Medicine Journal. 14 (1) (pp 42-47), 2020. Date of
Publication: 2020.
Author
Oprzedkiewicz A.; Mado H.; Szczurek W.; Gasior M.; Szygula-Jurkiewicz B.
Institution
(Oprzedkiewicz, Mado, Gasior, Szygula-Jurkiewicz) 3rd Department of
Cardiology, School of Medical Sciences in Zabrze, Medical University of
Silesia, Katowice, Poland
(Szczurek) Silesian Center for Heart Diseases, Zabrze, Poland
Publisher
Bentham Science Publishers
Abstract
Heart transplantation remains the treatment of choice for end-stage Heart
Failure (HF). Due to the shortage of organs for transplantation and the
occurrence of perioperative complications, a key problem is donor
matching, which should result in increased survival and improved quality
of life for patients. The success of this procedure depends on various
parameters such as gender, weight, ABO blood group and Human Leukocyte
Antigen (HLA) system of both the recipient and the donor. Furthermore,
non-HLA antigens may also be valuable in donor-recipient matching. The aim
of this article is to summarize the recent knowledge on the impact of
various factors on accurate donor-recipient matching to heart
transplantation.<br/>Copyright &#xa9; 2020 Oprzedkiewicz et al.

<167>
Accession Number
632753757
Title
Vasopressor Therapy in the Intensive Care Unit.
Source
Seminars in Respiratory and Critical Care Medicine. 42 (1) (pp 59-77),
2021. Date of Publication: 01 Feb 2021.
Author
Russell J.A.; Gordon A.C.; Williams M.D.; Boyd J.H.; Walley K.R.; Kissoon
N.
Institution
(Russell, Boyd, Walley) Department of Medicine, Centre for Heart Lung
Innovation, St. Paul's Hospital, University of British Columbia,
Vancouver, BC, Canada
(Russell, Boyd, Walley) Division of Critical Care Medicine, St. Paul's
Hospital, University of British Columbia, Vancouver, BC, Canada
(Gordon) Department of Surgery and Cancer, Division of Anaesthetics, Pain
Medicine and Intensive Care, Imperial College London, London, United
Kingdom
(Gordon) Department of Surgery and Cancer, Intensive Care Unit, Imperial
College Healthcare Nhs Trust, St Mary's Hospital, London, United Kingdom
(Williams) Department of Medicine, Indiana University Health Methodist
Hospital, Indiana University School of Medicine, Indianapolis, IN, United
States
(Kissoon) Department of Pediatrics, British Columbia Children's Hospital,
University of British Columbia, Vancouver, BC, Canada
Publisher
Thieme Medical Publishers, Inc.
Abstract
After fluid administration for vasodilatory shock, vasopressors are
commonly infused. Causes of vasodilatory shock include septic shock,
post-cardiovascular surgery, post-acute myocardial infarction,
postsurgery, other causes of an intense systemic inflammatory response,
and drug -associated anaphylaxis. Therapeutic vasopressors are hormones
that activate receptors-adrenergic: alpha1, alpha2, beta1, beta2;
angiotensin II: AG1, AG2; vasopressin: AVPR1a, AVPR1B, AVPR2; dopamine:
DA1, DA2. Vasopressor choice and dose vary widely because of patient and
physician practice heterogeneity. Vasopressor adverse effects are
excessive vasoconstriction causing organ ischemia/infarction,
hyperglycemia, hyperlactatemia, tachycardia, and tachyarrhythmias. To
date, no randomized controlled trial (RCT) of vasopressors has shown a
decreased 28-day mortality rate. There is a need for evidence regarding
alternative vasopressors as first-line vasopressors. We emphasize that
vasopressors should be administered simultaneously with fluid replacement
to prevent and decrease duration of hypotension in shock with
vasodilation. Norepinephrine is the first-choice vasopressor in septic and
vasodilatory shock. Interventions that decrease norepinephrine dose
(vasopressin, angiotensin II) have not decreased 28-day mortality
significantly. In patients not responsive to norepinephrine, vasopressin
or epinephrine may be added. Angiotensin II may be useful for rapid
resuscitation of profoundly hypotensive patients. Inotropic agent(s)
(e.g., dobutamine) may be needed if vasopressors decrease ventricular
contractility. Dopamine has fallen to almost no-use recommendation because
of adverse effects; angiotensin II is available clinically; there are
potent vasopressors with scant literature (e.g., methylene blue); and the
novel V1a agonist selepressin missed on its pivotal RCT primary outcome.
In pediatric septic shock, vasopressors, epinephrine, and norepinephrine
are recommended equally because there is no clear evidence that supports
the use of one vasoactive agent. Dopamine is recommended when epinephrine
or norepinephrine is not available. New strategies include perhaps
patients will be started on several vasopressors with complementary
mechanisms of action, patients may be selected for particular vasopressors
according to predictive biomarkers, and novel vasopressors may emerge with
fewer adverse effects.<br/>Copyright &#xa9; 2021 BMJ Publishing Group. All
rights reserved.

<168>
Accession Number
629634839
Title
Music Interventions in Percutaneous Coronary Procedures: A Meta-Analysis.
Source
Clinical nursing research. 30 (2) (pp 135-145), 2021. Date of Publication:
01 Feb 2021.
Author
Su S.-F.; Yeh W.-T.
Institution
(Su) Department of Nursing, National Taichung University of Science and
Technology, Taichung City, Taiwan (Republic of China)
(Yeh) Department of Nursing, Taichung Veterans General Hospital, Taichung
City, Taiwan (Republic of China)
Publisher
NLM (Medline)
Abstract
To clarify the effectiveness of music intervention for improving the
well-being of patients undergoing coronary procedures for coronary heart
disease, we conducted full-text searches of various databases (MEDLINE,
Cochrane Library, CINAHL, ProQuest, and Airiti Library; 1966-2019) to
identify randomized controlled trials and quasi-experimental studies of
music intervention in recipients of angiography or percutaneous coronary
intervention. Outcome measures included anxiety, discomfort, pain, heart
rate, and blood pressure. The Cochrane methodology, Jadad Quality Score,
and ROBINS-I were employed to evaluate evidence from 10 studies. Music
intervention reduced anxiety (effect size: Z = 2.15, p = .03; six studies)
and discomfort of lying (Z = 2.40, p = .02; two studies), but did not
affect pain (Z = 0.94; two studies), heart rate (Z = 0.94; five studies),
or blood pressure (systolic, Z = 1.27; diastolic, Z = 1.32; four studies)
(all p > .05). The heterogeneity among studies was high. Large-scale,
transcultural, high-quality trials are warranted to confirm the benefit of
music intervention in patients undergoing coronary procedures.

<169>
Accession Number
2010324642
Title
Ivabradine plus conventional treatment vs conventional treatment alone in
reducing the mean heart rate in heart transplant recipients: A randomized
clinical trial.
Source
Clinical Transplantation. (no pagination), 2021. Date of Publication:
2021.
Author
dos Santos C.C.; Rossi Neto J.M.; Finger M.A.; Timerman A.; Contreras C.;
Chaccur P.
Institution
(dos Santos, Rossi Neto, Finger, Timerman, Contreras, Chaccur) Instituto
Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
Publisher
Blackwell Publishing Ltd
Abstract
The absence of afferent nerves for heart rate (HR) regulation leaves the
transplanted heart under the influence of its internal and hormonal
control. The HR of heart transplantation (HTx) recipients varies from to
90-110 bpm, indicating a lack of vagal parasympathetic tone. We
hypothesized that the reduction in mean HR using an If-channel antagonist
(ivabradine) could be effective and safe in HTx recipients. The primary
objective of this open-label randomized clinical trial was to compare the
mean HR at 3, 6, 12, 18, 24, 30, and 36 months after randomization between
an ivabradine plus conventional treatment group (IG) and conventional
treatment alone group (CG). The secondary objectives were reduction in
mortality, graft dysfunction, and ventricular mass. All patients were
randomized between 1 and 12 months after HTx. Ivabradine started at
randomization. Of the 35 patients, 54.28% were in the CG and 45.72% in the
IG. There were no significant between-group differences in demographics.
Over time, the HR differences between the groups became significant (P
<.01). There were no significant between-group differences in mortality,
graft dysfunction, and ventricular mass. We conclude that ivabradine could
effectively and consistently reduce the HR in HTx
recipients.<br/>Copyright &#xa9; 2021 John Wiley & Sons A/S. Published by
John Wiley & Sons Ltd

<170>
Accession Number
2010284492
Title
Vasoplegia in patients following ventricular assist device explant and
heart transplantation.
Source
Perfusion (United Kingdom). (no pagination), 2021. Date of Publication:
2021.
Author
Emmanuel S.; Pearman M.; Jansz P.; Hayward C.S.
Institution
(Emmanuel, Pearman, Jansz, Hayward) St Vincent's Hospital, Sydney, NSW,
Australia
(Emmanuel, Jansz, Hayward) School of Medicine, University of New South
Wales, Sydney, NSW, Australia
(Emmanuel, Pearman, Jansz) School of Medicine, University of Notre Dame,
Sydney, NSW, Australia
(Emmanuel, Jansz, Hayward) The Victor Chang Cardiac Research Institute,
Sydney, NSW, Australia
Publisher
SAGE Publications Ltd
Abstract
Background: Vasoplegia has been shown to be associated with increased
morbidity and mortality in patients undergoing cardiac surgery. It has
been previously stated that low pulsatile states as seen with current left
ventricular assist devices (LVADs) may contribute to vasoplegia post
LVAD-explant and heart transplant. We sought to examine the literature
regarding vasoplegia in the post-operative setting for patients undergoing
LVAD explant and heart transplant. <br/>Method(s): A literature review was
conducted to firstly define vasoplegia in the setting of LVAD patients,
and secondly to better understand the relationship between vasoplegia and
LVAD explantation in the postoperative heart transplant patient cohort. A
keyword search of 'vasoplegia' OR 'vasoplegic' AND 'transplant' was used.
Search engines used were PubMed, Cochrane Library, ClinicalTrials.gov,
Ovid, Scopus and grey literature. <br/>Result(s): 17 studies met the
selection criteria for review. Three key themes emerged from the
literature. Firstly, there is limited consensus regarding the definition
of vasoplegia. Secondly, patients with LVADs experienced higher rates of
vasoplegia following heart transplant than their counterparts and thirdly,
increased cardiopulmonary bypass time was associated with a higher rate of
vasoplegia. <br/>Conclusion(s): Vasoplegia is not clearly defined in the
literature as it pertains to the LVAD patient cohort. Patients bridged
with LVADs appear to have higher rates of vasoplegia, however the
aetiology of this is unclear and may be associated with continuous flow
physiology or prolonged cardiopulmonary bypass time. A universal
definition will aid in risk stratification, early recognition and
management.<br/>Copyright &#xa9; The Author(s) 2021.

<171>
Accession Number
2010284454
Title
Left or bilateral internal mammary artery employment in coronary artery
bypass grafting: midterm results.
Source
Asian Cardiovascular and Thoracic Annals. (no pagination), 2021. Date of
Publication: 2021.
Author
Fomenko M.S.; Schneider Y.A.; Tsoi V.G.; Pavlov A.A.; Shilenko P.A.
Institution
(Fomenko, Schneider, Tsoi, Pavlov, Shilenko) Federal State Budgetary
Institution, Federal Centers of High Medical Technologies, Health
Ministry, Kaliningrad, Russian Federation
Publisher
SAGE Publications Inc.
Abstract
Background: The gold standard for coronary artery bypass grafting to the
left anterior descending artery is use of the left internal mammary
artery. Better long-term survival has been reported using bilateral
internal mammary arteries compared to left internal mammary artery only,
but many surgeons are reluctant to employ bilateral internal mammary
arteries in coronary artery bypass grafting. This study aimed to evaluate
the effectiveness and safety of bilateral internal mammary artery use.
<br/>Method(s): From 2014 to 2017, 1703 patients underwent coronary artery
bypass grafting in our institute. Of these, 772 met the inclusion criteria
and were randomly assigned to receive bilateral (n = 387) or left (n =
385) internal mammary artery grafts. The mean age was 67.1 +/- 6.0 years
(range 48-85 years) and 474 (61.4%) were male. The mean number of diseased
vessels was 3.1 +/- 0.9, and mean EuroSCORE II was 3.4% +/- 1.1%.
<br/>Result(s): Hospital mortality was 1.2% in the left internal mammary
artery group vs. 1.8% in the bilateral internal mammary artery group (p =
0.55). There was no difference in procedure-related complications between
groups. Mean follow-up was 65.9 months. Survival in the bilateral internal
mammary artery group at 1, 3, and 5 years was 98.7%, 98.7%, and 94.8% vs.
98.1%, 98.1%, and 90.9%, respectively, in the left internal mammary artery
group (p = 0.63). <br/>Conclusion(s): Application of bilateral internal
mammary arteries in coronary artery bypass grafting is safe and effective,
with comparable midterm results to those with the left internal mammary
artery only.<br/>Copyright &#xa9; The Author(s) 2021.

<172>
Accession Number
2010217295
Title
Transapical off-pump mitral valve repair with NeoChord implantation: A
systematic review.
Source
Journal of Cardiac Surgery. (no pagination), 2021. Date of Publication:
2021.
Author
Ahmed A.; Abdel-Aziz T.A.; AlAsaad M.M.R.; Majthoob M.
Institution
(Ahmed) Department of Cardiothoracic Surgery, Faculty of Medicine, Ain
Shams University, Cairo, Egypt
(Abdel-Aziz, AlAsaad, Majthoob) Department of Cardiothoracic Surgery,
Dubai Hospital, Dubai, United Arab Emirates
Publisher
Blackwell Publishing Inc.
Abstract
Introduction: Mitral valve repair (MVr) is the gold standard for the
treatment of degenerative mitral valve regurgitation (MR). The recently
introduced NeoChord DS1000 has gained increasing recognition as a
feasible, potentially safe, and effective procedure with minor
complications and promising outcomes. This study aims to conduct a
systematic review of the published literature that discusses the technical
feasibility and outcome of transapical off-pump MVr with NeoChord DS1000
device implantation in the treatment of degenerative MR. <br/>Method(s):
This review was performed according to the PRISMA statement. Databases
searched in this review included Pubmed, Web of Science, Scopus, and
Cochrane databases for systematic reviews. All English articles on humans
reporting isolated MVr using NeoChord DS1000 device were included provided
that basic preoperative data, operative specifications, and postoperative
mortality and morbidity were reported. <br/>Result(s): This review
included six studies comprised 249 patients who had NeoChord mitral
procedure. Almost all patients included had severe MR (243/249, 97.6%).
Operative success was achieved in 241 out of the 249 patients (96.8%). No
intraoperative mortality was reported. Intraoperative arrhythmia was
reported in six patients (2.4%) and significant bleeding was reported in
eight patients (3.2%). <br/>Conclusion(s): Awaiting more evidence,
NeoChord mitral procedure appears to be a promising procedure that can be
considered in selected cases.<br/>Copyright &#xa9; 2021 Wiley Periodicals
LLC

<173>
Accession Number
2010217281
Title
Sternal closure with single compared with double or figure-of-8 wires in
obese patients post cardiac surgery.
Source
Journal of Cardiac Surgery. (no pagination), 2021. Date of Publication:
2021.
Author
Shafi A.M.A.; Abuelgasim E.; Abuelgasim B.; Iddawela S.; Harky A.
Institution
(Shafi) Department of Cardiothoracic Surgery, St Bartholomew's Hospital,
Barts Heart Centre, London, United Kingdom
(Abuelgasim, Abuelgasim) Faculty of Medicine, Imperial College London,
London, United Kingdom
(Iddawela) Department of Respiratory Medicine, University Hospitals
Birmingham, Birmingham, United Kingdom
(Harky) Department of Cardiothoracic Surgery, Liverpool Heart and Chest
Hospital, Liverpool, United Kingdom
(Harky) Department of Integrative Biology, Faculty of Health and Life
Sciences, University of Liverpool, Liverpool, United Kingdom
Publisher
Blackwell Publishing Inc.
Abstract
Objectives: Sternal instability and wound infections are major causes of
morbidity following cardiac surgery, which is further amplified in high
risk patients that include diabetics and patients with high body mass
index (BMI). We compare the different outcomes of different sternal wire
closure techniques following median sternotomy for cardiac surgery in
obese patients. <br/>Method(s): A comprehensive electronic literature
search was undertaken according to PRISMA guidelines from inception to
July 2020 to identify all published data comparing single wire sternal
closure to either double wire or figure-of-8 techniques following median
sternotomy for cardiac surgery in obese patients, defined as a BMI >= 30.
<br/>Result(s): Eight studies met the final inclusion criteria; single
wire versus double wire sternal closure (n = 2) and single wire versus
figure-of-8 wire closure (n = 6). Higher rate of sternal instability was
noted in single wire versus double wire closure (22/150 [14.7%] patients
vs. 6/150 [4%] patients, p = 0.003, odd ratio [OR] 0.25 [95% confidence
interval [CI] 0.10-0.63]). Similarly, sternal instability was higher in
single wire vs figure-of-8 wire closure technique (33/2422 [1.3%] vs.
11/8035 [0.1%], p = 0.04 OR 0.30 [95% CI, 0.09-0.96]), respectively.
<br/>Conclusion(s): There is benefit in the use of either double or
figure-of-8 sternal wire closure techniques over single wire closure in
terms of sternal instability. However, as the studies were limited, larger
scale comparative studies are required to provide a solid evidence base
for choosing the optimal sternal closure technique in this high risk group
of patients.<br/>Copyright &#xa9; 2021 Wiley Periodicals LLC

<174>
Accession Number
632111175
Title
Effects of Lidocaine Oropharyngeal Spray Applied Before Endotracheal
Intubation on QT Dispersion in Patients Undergoing Coronary Artery Bypass
Grafting: A Prospective Randomized Controlled Study.
Source
Brazilian journal of cardiovascular surgery. 35 (3) (pp 291-298), 2020.
Date of Publication: 01 Jun 2020.
Author
Bilgi M.; Velioglu Y.; Yoldas H.; Cosgun M.; Yuksel A.; Karagoz I.; Yildiz
I.; Es A.; Caliskan D.; Erdem K.; Demirhan A.
Institution
(Bilgi, Velioglu, Yoldas, Cosgun, Yuksel, Karagoz, Yildiz, Caliskan,
Erdem, Demirhan) Abant Izzet Baysal University Medical School Bolu Turkey
Abant Izzet Baysal University Medical School, Bolu, Turkey
(Es) Abant Izzet Baysal University Faculty of Economics and Administrative
Sciences Bolu Turkey Abant Izzet Baysal University Faculty of Economics
and Administrative Sciences, Bolu, Turkey
Publisher
NLM (Medline)
Abstract
OBJECTIVE: To investigate the effects of lidocaine oropharyngeal spray
applied before endotracheal intubation on hemodynamic responses and
electrocardiographic parameters in patients undergoing coronary artery
bypass grafting. <br/>METHOD(S): A total of 60 patients who underwent
coronary artery bypass grafting surgery were included in this prospective
randomized controlled study. Patients were randomly divided into two
groups, the topical lidocaine group (administration of 10% lidocaine
oropharyngeal spray, five minutes before laryngoscopy and endotracheal
intubation) and the control group. Both groups were compared with each
other in terms of main hemodynamic parameters including mean arterial
pressure and heart rate, as well as P and QT wave dispersion durations,
before and after endotracheal intubation. <br/>RESULT(S): The groups were
similar in terms of age, gender, and other demographics and basic clinical
characteristics. There was a statistically significant difference between
the groups in terms of QT dispersion durations after laryngoscopy and
endotracheal intubation. The increase in QT dispersion duration was not
statistically significant in the topical lidocaine group, whereas the
increase in QT dispersion duration was statistically significant in the
control group. When the groups were compared in terms of P wave dispersion
durations, there were significant decreases in both groups, but there was
no significant difference between the groups. <br/>CONCLUSION(S): Our
study revealed that the topical lidocaine administration before
endotracheal intubation prevented increase of QT dispersion duration in
patients undergoing coronary artery bypass grafting. TRIAL REGISTRATION:
NCT03304431.

<175>
Accession Number
632111050
Title
Transcatheter aortic valve implantation versus surgical aortic valve
replacement for treatment of severe aortic stenosis: comparison of results
from randomized controlled trials and real-world data.
Source
Brazilian journal of cardiovascular surgery. 35 (3) (pp 346-367), 2020.
Date of Publication: 01 Jun 2020.
Author
Wang D.; Huang L.; Zhang Y.; Cheng Z.; Zhang X.; Ren P.; Hong Q.; Kang D.
Institution
(Wang, Huang, Zhang, Hong, Kang) Sichuan University West China Hospital
Department of Evidence-based Medicine and Clinical Epidemiology Chengdu
Sichuan China Department of Evidence-based Medicine and Clinical
Epidemiology, West China Hospital, Sichuan University, Chengdu, Sichuan,
China
(Cheng) Sichuan University West China Hospital Department of
Cardiovascular Surgery Chengdu Sichuan China Department of Cardiovascular
Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China
(Zhang) West China Hospital, Sichuan University, Sichuan University West
China Hospital Department of Integrated Traditional Chinese and Western
Medicine China Department of Integrated Traditional Chinese and Western
Medicine
(Ren) Sichuan University West China Hospital Clinical Research Center for
Respiratory Diseases Chengdu Sichuan China Clinical Research Center for
Respiratory Diseases, West China Hospital, Sichuan University, Chengdu,
Sichuan, China
Publisher
NLM (Medline)
Abstract
OBJECTIVE: Results from randomized controlled trials (RCTs) and real-world
study (RWS) appear to be discordant. We aimed to investigate whether data
derived from RCTs and RWS evaluating long-term all-cause mortality of
transcatheter aortic valve implantation (TAVI) versus surgical aortic
valve replacement (SAVR) in patients with severe aortic stenosis (AS) were
in agreement. <br/>METHOD(S): RCTs or RWS comparing TAVI and SAVR,
reporting longterm (>=2-year follow-up) all-cause mortality, were
identified. We also carried out subgroup analyses to access the effect in
different subgroups. A pre-designated data extraction form including 5
domains and 26 items was used to explore the relationship between RCTs and
RWS. Mortality and effect in different subgroups were evaluated using
random-effects meta-analyses. <br/>RESULT(S): Five RCTs (5421
participants, TAVI: 2759, SAVR: 2662) and 33 RWS (20839 participants;
TAVI: 6585, SAVR: 14254) were identified. Pooled RCT analysis showed no
difference in all-cause mortality between TAVI and SAVR (HR=0.97, 95% CI:
0.88-1.07; P=0.55). In RWS, TAVI was associated with an increased risk of
allcause mortality (HR=1.46, 95% CI: 1.26-1.69; P<0.001) compared to SAVR.
<br/>CONCLUSION(S): These results highlight the inconsistencies between
RCTs and RWS in assessing long-term all-cause mortality in the treatment
of AS using TAVI or SAVR, which may be caused by interactions of clinical
characteristics or study design. RCTs as well as RWS are both developing
and improving; the advantages of one kind of design, measurement and
evaluation can and should be thoughtfully referred to the other.

<176>
Accession Number
2010725848
Title
Systematic review and meta-analysis of valve-in-valve transcatheter aortic
valve replacement in patients with failed bioprosthetic aortic valves.
Source
EuroIntervention. 16 (7) (pp 539-548), 2021. Date of Publication: 2021.
Author
Mahmoud A.N.; Gad M.M.; Elgendy I.Y.; Mahmoud A.A.; Taha Y.; Elgendy A.Y.;
Ahuja K.R.; Saad A.M.; Simonato M.; McCabe J.M.; Reisman M.; Kapadia S.R.;
Dvir D.
Institution
(Mahmoud, McCabe, Reisman, Dvir) Division of Cardiology, University of
Washington, Seattle, WA, United States
(Gad, Ahuja, Saad, Kapadia) Cleveland Clinic, Heart and Vascular
Institute, Cleveland, OH, United States
(Elgendy) Division of Cardiology, Massachusetts General Hospital, Harvard
Medical School, Boston, MA, United States
(Mahmoud, Taha) Department of Medicine, University of Florida,
Gainesville, FL, United States
(Elgendy) Division of Cardiology, University of Florida, Gainesville, FL,
United States
(Simonato) Escola Paulista de Medicina, Universidade Federal de Sao Paulo,
Sao Paulo, Brazil
Publisher
Europa Group
Abstract
Aims: The aim of this meta-analysis was to evaluate the evidence regarding
the rates of procedural success and the incidence of adverse outcomes
following valve-in-valve (VIV) transcatheter aortic valve replacement
(TAVR) in patients with failed bioprosthetic aortic valves. <br/>Methods
and Results: A systematic search of major electronic databases was
conducted for studies relevant to patients with failed bioprosthetic
aortic valves undergoing VIV-TAVR. The primary outcome was procedural
success. A total of 5,553 patients from 24 studies were included. The mean
Society of Thoracic Surgeons (STS) score was 7.84+/-5.14. The procedural
success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30
days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%),
myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6%
(95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year,
the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3%
(95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent
pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of
all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%).
<br/>Conclusion(s): VIV-TAVR appears to be associated with high procedural
success rates and low adverse outcomes during the short-term and midterm
follow-up period.<br/>Copyright &#xa9; Europa Digital & Publishing 2020.
All rights reserved.

<177>
Accession Number
2010725794
Title
Influence of final kissing balloon inflation on long-term outcomes after
PCI of distal left main bifurcation lesions in the EXCEL trial.
Source
EuroIntervention. 16 (3) (pp 218-224), 2021. Date of Publication: 2021.
Author
Kini A.S.; Dangas G.D.; Baber U.; Vengrenyuk Y.; Kandzari D.E.; Leon M.B.;
Morice M.-C.; Serruys P.W.; Kappetein A.P.; Sabik J.F.; Dressler O.;
Mehran R.; Sharma S.K.; Stone G.W.
Institution
(Kini, Dangas, Baber, Vengrenyuk, Mehran, Sharma, Stone) Mount Sinai
Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Dangas, Leon, Dressler, Mehran, Stone) Clinical Trials Center,
Cardiovascular Research Foundation, New York, NY, United States
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Leon) New York Presbyterian Hospital, Columbia University Medical Center,
New York, NY, United States
(Morice) Hopital Prive Jacques Cartier, Ramsay Generale de Sante, Massy,
France
(Serruys) Department of Cardiology, NUIG, National University of Ireland,
Galway, Ireland
(Serruys) Imperial College of Science, Technology and Medicine, London,
United Kingdom
(Kappetein) Thoraxcenter, Erasmus MC, Rotterdam, Netherlands
(Sabik) Department of Surgery, UH Cleveland Medical Center, Cleveland, OH,
United States
Publisher
Europa Group
Abstract
Aims: The impact of final kissing balloon inflation (FKBI) after
percutaneous coronary intervention (PCI) of bifurcation lesions on
long-term clinical outcomes remains controversial. We sought to determine
the impact of FKBI on four-year outcomes after PCI of distal left main
(LM) bifurcation lesions. <br/>Methods and Results: The EXCEL trial
compared PCI with everolimus-eluting stents and coronary artery bypass
graft surgery (CABG) in patients with left main (LM) disease. We examined
four-year clinical outcomes after PCI of distal LM bifurcation lesions
according to use of FKBI. The primary endpoint was the composite rate of
death, myocardial infarction (MI), or stroke. The major secondary endpoint
was the composite rate of death, MI, stroke, or ischaemia-driven
revascularisation (IDR). Among 948 patients randomised to PCI, 759 had
distal LM lesions treated, 430 of which were treated with one stent and
329 of which were treated with two or more stents. The four-year rates of
the primary and major secondary endpoints were similar with versus without
FKBI in both the one-stent and >=2-stent groups in both unadjusted and
adjusted analyses. <br/>Conclusion(s): In the EXCEL trial, the performance
of FKBI after PCI of distal LM bifurcation lesions was not associated with
improved four-year clinical outcomes regardless of whether one stent or
>=2 stents were implanted.<br/>Copyright &#xa9; Europa Digital &
Publishing 2020. All rights reserved.

<178>
Accession Number
2010725786
Title
Short-duration triple antithrombotic therapy for atrial fibrillation
patients who require coronary stenting: Results of the SAFE - A study.
Source
EuroIntervention. 16 (2) (pp E164-E172), 2021. Date of Publication: 2021.
Author
Hoshi T.; Sato A.; Hiraya D.; Watabe H.; Takeyasu N.; Nogami A.; Ohigashi
T.; Gosho M.; Ieda M.; Aonuma K.
Institution
(Hoshi, Sato, Hiraya, Watabe, Nogami, Ieda, Aonuma) Department of
Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba City,
Ibaraki, Japan
(Takeyasu) Department of Cardiology, Ibaraki Prefectural Central Hospital,
Ibaraki, Japan
(Ohigashi) Department of Biostatistics, Tsukuba Clinical Research &
Development Organization, University of Tsukuba, Tsukuba City, Ibaraki,
Japan
(Gosho) Department of Biostatistics, Faculty of Medicine, University of
Tsukuba, Tsukuba City, Ibaraki, Japan
Publisher
Europa Group
Abstract
Aims: We aimed to determine whether shortening the duration of
P2Y<inf>12</inf> inhibitor therapy can reduce the risk of bleeding without
increasing the risk of major adverse cardiovascular events following
coronary stenting in patients with atrial fibrillation (AF). <br/>Methods
and Results: The SAFE-A is a randomised controlled trial that compared
one-month and six-month P2Y<inf>12</inf> inhibitor therapy, in combination
with aspirin and apixaban for patients with AF who require coronary
stenting. The primary endpoint was the incidence of any bleeding events,
defined as Thrombolysis In Myocardial Infarction major/minor bleeding,
bleeding with various Bleeding Academic Research Consortium grades, or
bleeding requiring blood transfusion within 12 months after stenting. The
study aimed to enrol 600 patients but enrolment was slow. Enrolment was
terminated prematurely after enrolling 210 patients (72.7+/-8.2 years; 81%
male). The incidence of the primary endpoint did not differ between the
one-month and six-month groups (11.8% vs 16.0%; hazard ratio [HR] 0.70,
95% confidence interval [CI]: 0.33-1.47; p=0.35). <br/>Conclusion(s): The
study evaluated the safety of withdrawing the P2Y<inf>12</inf> inhibitor
from triple antithrombotic prescription one month after coronary stenting.
However, enrolment was prematurely terminated because it was slow.
Therefore, statistical power was not sufficient to assess the differences
in the primary endpoint.<br/>Copyright &#xa9; Europa Digital & Publishing
2020. All rights reserved.

<179>
Accession Number
2010744902
Title
Frailty Screening Tool for Patients Undergoing Orthotopic Heart
Transplant.
Source
Annals of Thoracic Surgery. 111 (2) (pp 586-593), 2021. Date of
Publication: February 2021.
Author
Seese L.; Hirji S.; Sultan I.; Gleason T.; Kilic A.
Institution
(Seese, Sultan, Gleason, Kilic) Division of Cardiac Surgery, University of
Pittsburgh Medical Center, Pittsburgh, PA, United States
(Hirji) Division of Cardiac Surgery, Brigham and Women's Hospital, Boston,
MA, United States
Publisher
Elsevier Inc.
Abstract
Background: Although frailty has been previously shown to negatively
influence postoperative outcomes, frailty measurements remain undefined
and underused for patients undergoing orthotopic heart transplantation
(OHT). This study aims to derive and validate an OHT frailty screening
tool. <br/>Method(s): The United Network for Organ Sharing database was
queried for adults undergoing OHT between 2000 and 2018. The total
population was randomly divided into derivation (80%) and validation (20%)
cohorts. The primary outcome was mortality. Secondary outcomes included
rates of major morbidities and hospital length of stay. Variables that
were constructs within preexisting frailty tools and that were predictive
of a composite frailty outcome within the derivation cohort were
incorporated into a multivariable regression model (exploratory, P < .2).
Independent predictors of frailty were included in the OHT frailty
screening tool. <br/>Result(s): A total of 36,790 OHT recipients met the
criteria for inclusion. Twelve variables were identified as independent
predictors of frailty and included as OHT frailty screening tool
constructs. Recipients in the validation cohort were stratified as
nonfrail (72.9%, n = 5363), prefrail (24.4%, n = 1795), and frail (2.7%, n
= 200). Frail patients had significantly higher rates of posttransplant
stroke, renal failure, and mortality at all time intervals as well as
longer length of stay (all P < .001). The risk model's predictive rates of
mortality strongly correlated with the observed rates of mortality
(r² = 0.97, P < .001). The c-index of the OHT frailty score was
0.74. <br/>Conclusion(s): The OHT frailty screening tool is highly
predictive of adverse posttransplant outcomes. This screening tool may
provide a framework to enhance existing risk stratification tools and
improve overall resource utilization.<br/>Copyright &#xa9; 2021 The
Society of Thoracic Surgeons

<180>
Accession Number
2010856780
Title
Does metformin improve the efficacy of standard epidermal growth factor
receptor-tyrosine kinase inhibitor treatment for patients with advanced
non-small-cell lung cancer?.
Source
Interactive Cardiovascular and Thoracic Surgery. 32 (1) (pp 73-76), 2021.
Date of Publication: 01 Jan 2021.
Author
Lin Z.; Li G.; Xu X.; Mei J.
Institution
(Lin, Li, Xu, Mei) West China School of Medicine, Sichuan University,
Chengdu, China
(Lin, Mei) Department of Thoracic Surgery, West China Hospital, Sichuan
University, Chengdu, China
(Mei) W. China Collab. Innovation Center for Early Diagnosis and
Multidisciplinary Therapy of Lung Cancer, Sichuan University, Chengdu,
China
Publisher
Oxford University Press
Abstract
A best evidence topic in thoracic surgery was written according to a
structured protocol. The question addressed was whether metformin improved
the efficacy of standard epidermal growth factor receptor-tyrosine kinase
inhibitor (EGFR-TKI) treatment for patients with epidermal growth factor
receptor (EGFR)-mutated advanced non-small-cell lung cancer. A total of 99
papers were found using the reported search, of which 4 represented the
best evidence to answer this clinical question. The authors, journal,
publication date, country, study type, treatment regimen, relevant
outcomes and results of these papers are tabulated. We concluded that the
addition of metformin to EGFR-TKI might improve the survival of patients
with EGFR-mutated non-small-cell lung cancer and diabetes mellitus type 2.
However, for non-diabetic non-small-cell lung cancer patients with EGFR
mutation, the efficiency of additional metformin in EGFR-TKI treatment
remains unclear because of the conflicting results of only 2 available
studies. <br/>Copyright &#xa9; 2020 The Author(s) 2020. Published by
Oxford University Press on behalf of the European Association for
Cardio-Thoracic Surgery. All rights reserved.

<181>
[Use Link to view the full text]
Accession Number
634018957
Title
Simvastatin treatment protects myocardium in noncoronary artery cardiac
surgery by inhibiting apoptosis through miR-15a-5p targeting.
Source
Journal of Cardiovascular Pharmacology. 72 (4) (pp 176-185), 2018. Date of
Publication: October 2018.
Author
Zhou L.; Liu X.; Wang Z.-Q.; Li Y.; Shi M.-M.; Xu Z.; Ou Z.-J.; Li H.-M.;
Cheng T.-P.; Jian Y.-P.; Zhang W.; Liu C.; Zhang X.; Quon M.J.; Zhang
C.-X.; Xu Y.-Q.; Wang Z.-P.; Ou J.-S.
Institution
(Zhou, Liu, Wang, Li, Shi, Xu, Li, Cheng, Jian, Zhang, Zhang, Xu, Wang,
Ou) Division of Cardiac Surgery, Heart Center, First Affiliated Hospital
of Sun Yat-sen University, Guangzhou, China
(Zhou, Liu, Wang, Li, Shi, Xu, Ou, Li, Cheng, Jian, Zhang, Liu, Zhang, Xu,
Wang, Ou) Key Laboratory of Assisted Circulation, Ministry of Health,
Guangzhou, China
(Liu, Wang, Li, Shi, Ou, Li, Cheng, Jian, Liu, Ou) National and Guangdong
Province Joint Engineering Laboratory for Diagnosis and Treatment of
Vascular Diseases, Guangzhou, China
(Ou) Division of Hypertension and Vascular Diseases, Heart Center, First
Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
(Liu) Department of Cardiology, Heart Center, First Affiliated Hospital of
Sun Yat-sen University, Guangzhou, China
(Quon) Division of Endocrinology, Diabetes, and Nutrition, University of
Maryland School of Medicine, Baltimore, MD, United States
(Zhang) Department of Biomedical Engineering, School of Medicine,
University of Alabama at Birmingham, Birmingham, AL, United States
(Ou) Guangdong Provincial Key Laboratory of Brain Function and Disease,
Guangzhou, China
(Xu, Wang, Ou) Division of Cardiac Surgery, Heart Center, First Affiliated
Hospital of Sun Yat-sen University, 58 Zhong Shan Er Rd, Guangzhou 510080,
China
Publisher
Lippincott Williams and Wilkins
Abstract
Simvastatin treatment is cardioprotective in patients undergoing
noncoronary artery cardiac surgery. However, the mechanisms by which
simvastatin treatment protects the myocardium under these conditions are
not fully understood. Seventy patients undergoing noncoronary cardiac
surgery, 35 from a simvastatin treatment group and 35 from a control
treatment group, were enrolled in our clinical study. Simvastatin (20
mg/d) was administered preoperatively for 5-7 days. Myocardial tissue
biopsies were taken before and after surgery. Apoptosis was detected by
TUNEL staining. The expressions of Bcl-2 and Bak in myocardial tissue were
detected by immunoblotting. The expressions of miRNA and Bcl-2 mRNA were
detected by quantitative real-time polymerase chain reaction assays.
Cardiomyocytes were isolated from rat and cultured cells. MiR-15a-5p mimic
was transfected into cardiomyocytes, and the Bcl-2 was detected by
immunoblotting. TUNEL staining showed significantly less myocardial
apoptosis in the simvastatin treatment group when compared with the
control treatment group. Protein expression of Bcl-2 was increased in the
simvastatin treatment group before surgery, and Bak expression was
increased in the control treatment group after surgery. Further
comparisons showed that Bcl-2/Bak ratios were reduced in the control
treatment group but were not significantly changed in the simvastatin
treatment group after surgery. Furthermore, microarray assays revealed
that miR-15a-5p was significantly decreased by simvastatin treatment. This
was validated by quantitative real-time polymerase chain reaction
analysis. MiR-15a-5p was predicted to target Bcl-2 mRNA at nucleotide
positions 2529-2536. This was validated by luciferase binding assays.
Coincident with the change in miR-15a-5p, the mRNA expression of Bcl-2 was
increased in the simvastatin treatment group. MiR-15a-5p mimic
significantly inhibited Bcl-2 expression in cardiomyocytes. Our findings
strongly suggest that simvastatin treatment preoperatively protected the
myocardium in patients undergoing noncoronary artery cardiac surgery, at
least in part, by inhibiting apoptosis via suppressing miR-15a-5p
expression, leading to increasing expression of Bcl-2 and decreasing
expression of Bak.<br/>Copyright &#xa9; 2018 Wolters Kluwer Health, Inc.
All rights reserved.

<182>
Accession Number
2010325983
Title
Pernicious pregnancy: Type B aortic dissection in pregnant women.
Source
Journal of Cardiac Surgery. (no pagination), 2021. Date of Publication:
2021.
Author
Rimmer L.; Mellor S.; Harky A.; Gouda M.; Bashir M.
Institution
(Rimmer, Bashir) Vascular Surgery Department, Royal Blackburn Teaching
Hospital, Blackburn, United Kingdom
(Mellor) College of Medical and Dental Sciences, University of Birmingham,
Birmingham, United Kingdom
(Harky) Liverpool Heart and Chest Hospital NHS Foundation Trust,
Liverpool, United Kingdom
(Gouda) Vascular & Endovascular Surgery, Mataria Teaching Hospital, Cairo,
Egypt
Publisher
Blackwell Publishing Inc.
Abstract
Background: Type B aortic dissection (TBAD) occurs seldomly, particularly
in pregnancy, but has disastrous consequences for both mother and fetus.
The focus of immediate surgical repair of type A aortic dissection due to
higher mortality of patients is less clear in its counterpart, TBAD, in
which management is controversial and debated. This article collates
knowledge so far on this rare event during pregnancy. <br/>Method(s): A
comprehensive literature search was performed in PubMed, Scopus, Google
Scholar, Embase, and Medline. Key search terms included "type B aortic
dissection," "pregnancy," and corresponding synonyms. Non-English papers
were excluded. <br/>Result(s): Risk factors for TBAD include aortic wall
stress due to hypertension, previous cardiac surgery, structural
abnormalities (bicuspid aortic valve, aortic coarctation), and connective
tissue disorders. In pregnancy, pre-eclampsia is a cause of increased
aortic wall stress. Management of this condition is often conservative,
but this is dependent on a number of factors, including gestation,
cardiovascular stability of the patient, and symptomology. In most cases,
a cesarean section before intervention is carried out unless certain
indications are present. <br/>Conclusion(s): Due to a scarce number of
cases across the decades, it is difficult to determine which management is
optimal. The gold-standard management of TBAD has traditionally been the
medical treatment for uncomplicated cases and open surgery for those
needing urgent intervention, but with the advent of techniques, such as
thoracic endovascular aortic repair, the management of these group of
patients continues to develop.<br/>Copyright &#xa9; 2021 Wiley Periodicals
LLC

<183>
Accession Number
634060945
Title
Meta-analysis of Transcatheter Aortic Valve Implantation in Patients with
Stenotic Bicuspid vs. Tricuspid Aortic Valve.
Source
The American journal of cardiology. (no pagination), 2021. Date of
Publication: 15 Jan 2021.
Author
Majmundar M.; Kumar A.; Doshi R.; Shah P.; Arora S.; Shariff M.; Adalja
D.; Visco F.; Amin H.; Vallabhajosyula S.; Gullapalli N.; Kapadia S.R.;
Kalra A.; Panaich S.S.
Institution
(Majmundar) Department of Internal Medicine, Metropolitan Hospital Center,
New York Medical College, NY, United States
(Kumar, Shariff) Department of Critical Care Medicine, St John's Medical
College Hospital, Bangalore, India
(Doshi, Gullapalli) Department of Internal Medicine, University of Nevada
Reno School of Medicine, Reno, NV, United States
(Shah) Department of Internal Medicine, Dhiraj Hospital, Sumandeep
Vidyapeeth, Vadodara, Gujarat, India
(Arora) Department of Cardiology, Case Western Reserve University,
Cleveland, OH, USA
(Adalja) Department of Medicine, GMERS Gotri Medical College, Vadodara,
Gujarat, India
(Visco) Division of Cardiology, Department of Internal Medicine,
Metropolitan Hospital Center, New York Medical College, NY, United States
(Amin) Division of Pulmonary and Critical Care, Metropolitan Hospital
Center, New York Medical College, NY, United States
(Vallabhajosyula) Section of Intervention Cardiology, Division of
Cardiovascular Medicine, Department of Medicine, Emory University School
of Medicine, Atlanta, United States
(Kapadia) Department of Cardiovascular Medicine, Heart, Vascular and
Thoracic Institute, Cleveland Clinic, Cleveland, OH, United States
(Kalra) Department of Cardiovascular Medicine, Heart, Vascular and
Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Section of
Cardiovascular Research, Heart, Vascular and Thoracic Department,
Cleveland Clinic Akron General, Akron, Ohio
(Panaich) Department of Cardiovascular Medicine, University of Iowa
Hospitals and Clinics, Iowa City, IA, United States
Publisher
NLM (Medline)
Abstract
Most of the trials investigating the role of transcatheter aortic valve
implantation (TAVI) across various strata of risk categories have excluded
patients with bicuspid aortic stenosis (BAS) due to its anatomical
complexities. The aim of this study was to perform a meta-analysis with
meta-regression of studies comparing clinical, procedural, and
post-procedural echocardiographic outcomes in BAS versus tricuspid aortic
stenosis (TAS) undergoing TAVI. We searched the PubMed and Cochrane
databases for relevant articles from the inception of the database to
October 2019. Continuous and categorical variables were pooled using
inverse variance and Mantel-Haenszel method, respectively, using the
random-effect model. To rate the certainty of evidence for each outcome,
we used the GRADE (Grading of Recommendations, Assessment, Development,
and Evaluations) approach. Nineteen articles were included in the final
analysis. There was no difference in the risk of 30-day mortality, 1-year
mortality, 30-day cardiovascular mortality, major/life-threatening
bleeding, major vascular complications, acute kidney injury, permanent
pacemaker implantation, device success, annular rupture, post-procedural
aortic valve area and mean pressure gradient between the two groups. BAS
patients undergoing TAVI had a higher risk of 30-day stroke, conversion to
surgery, need for second valve implantation, and moderate to severe
paravalvular leak. In conclusion, the present meta-analysis supports the
feasibility of TAVI in surgically ineligible patients with BAS. However,
the incidence of certain procedural complications such as stroke,
conversion to surgery, second valve implantation, and paravalvular leak is
higher among BAS patients compared with TAS patients which must be
discussed with the patient prior to undergoing TAVI
procedure.<br/>Copyright &#xa9; 2021. Published by Elsevier Inc.

<184>
Accession Number
634060071
Title
Quadricuspid aortic valve: a case report and review of literature.
Source
Future cardiology. (no pagination), 2021. Date of Publication: 19 Jan
2021.
Author
Piracha U.G.; Kowlgi G.N.; Paulsen W.; Mojadidi M.K.; Patel N.
Institution
(Piracha, Paulsen, Mojadidi, Patel) Pauley Heart Center, Virginia
Commonwealth University, Richmond, United States
(Kowlgi) Department of Cardiovascular Medicine, Mayo Clinic, Rochester,
United States
Publisher
NLM (Medline)
Abstract
Quadricuspid aortic valve, a rare congenital cardiac defect, manifests
most commonly as aortic regurgitation. Clinical presentation mainly
depends on the functional status of the aortic valve, myocardium and
associated cardiovascular abnormalities. Aortic valve replacement or
repair is usually warranted in the 5th or 6th decade.

<185>
Accession Number
634070374
Title
Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of
Bempedoic acid on cardiovascular events in patients with statin
intolerance.
Source
American heart journal. (no pagination), 2020. Date of Publication: 23 Oct
2020.
Author
Nicholls S.J.; Lincoff A.M.; Bays H.E.; Cho L.; Grobbee D.E.; Kastelein
J.J.; Libby P.; Moriarty P.M.; Plutzky J.; Ray K.K.; Thompson P.D.;
Sasiela W.; Mason D.; McCluskey J.; Davey D.; Wolski K.; Nissen S.E.
Institution
(Nicholls) Monash Cardiovascular Research Centre, Monash University,
Melbourne, Australia
(Lincoff, Cho, Mason, McCluskey, Davey, Wolski, Nissen) Department of
Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic
Coordinating Center for Clinical Research
(Bays) Louisville Metabolic and Atherosclerosis Research Center, KY,
Louisville, United States
(Grobbee) University Medical Center Utrecht, Julius Center, Utrecht,
Netherlands
(Kastelein) Department of Vascular Medicine, University of Amsterdam
Academic Medical Center, Amsterdam, Netherlands
(Libby, Plutzky) Division of Cardiovascular Medicine, Brigham and Women's
Hospital, MA, Boston
(Moriarty) Clinical Pharmacology, University of Kansas Medical Center,
Kansas City, KS, United States
(Ray) Department of Primary Care & Public Health, Imperial College London,
London, United Kingdom
(Thompson) Division of Cardiology, CT, Hartford Hospital, Hartford, United
States
(Sasiela) Esperion Therapeutics, MI, Ann Arbor, United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: Although statins play a pivotal role in the prevention of
atherosclerotic cardiovascular disease, many patients fail to achieve
recommended lipid levels due to statin-associated muscle symptoms.
Bempedoic acid is an oral pro-drug that is activated in the liver and
inhibits cholesterol synthesis in hepatocytes, but is not activated in
skeletal muscle which has the potential to avoid muscle-related adverse
events. Accordingly, this agent effectively lowers atherogenic
lipoproteins in patients who experience statin-associated muscle symptoms.
However, the effects of bempedoic acid on cardiovascular morbidity and
mortality have not been studied. STUDY DESIGN: Cholesterol Lowering via
Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes is a
randomized, double-blind, placebo-controlled clinical trial. Included
patients must have all of the following: (i) established atherosclerotic
cardiovascular disease or have a high risk of developing atherosclerotic
cardiovascular disease, (ii) documented statin intolerance, and (iii) an
LDL-C>=100mg/dL on maximally-tolerated lipid-lowering therapy. The study
randomized 14,014 patients to treatment with bempedoic acid 180mg daily or
matching placebo on a background of guideline-directed medical therapy.
The primary outcome is a composite of the time to first cardiovascular
death, nonfatal myocardial infarction, nonfatal stroke, or coronary
revascularization. The trial will continue until 1620 patients experience
a primary endpoint, with a minimum of 810 hard ischemic events
(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke)
and minimum treatment duration of 36months and a projected median
treatment exposure of 42months. <br/>CONCLUSION(S): CLEAR Outcomes will
determine whether bempedoic acid 180mg daily reduces the incidence of
adverse cardiovascular events in high vascular risk patients with
documented statin intolerance and elevated LDL-C levels.<br/>Copyright
&#xa9; 2020 Elsevier Inc. All rights reserved.