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<1>
Accession Number
2010034768
Authors
Bassand J.-P. Afzal R. Eikelboom J. Wallentin L. Peters R. Budaj A. Fox
K.A.A. Joyner C.D. Chrolavicius S. Granger C.B. Mehta S. Yusuf S.
Institution
(Bassand) Department of Cardiology, University Hospital Jean Minjoz, EA
3920, 25000 Besanon, France.
(Afzal, Chrolavicius, Yusuf) Population Health Research Institute,
McMaster University, Hamilton, Canada.
(Eikelboom, Mehta) McMaster University, Hamilton, Canada.
(Wallentin) Uppsala Clinical Research Centre, University Hospital Uppsala,
Uppsala, Sweden.
(Peters) Academic Medical Center, Amsterdam, Netherlands.
(Budaj) Department of Cardiology, Postgraduate Medical School, Grochowski
Hospital, Warsaw, Poland.
(Fox) Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh,
United Kingdom.
(Joyner) Division of Cardiology, Sunnybrook Health Sciences Centre,
University of Toronto, Toronto, Canada.
(Granger) Duke Clinical Research Institute, Durham, NC 25000, United
States.
Title
Relationship between baseline haemoglobin and major bleeding complications
in acute coronary syndromes.
Source
European Heart Journal. 31(1)(pp 50-58), 2010. Date of Publication:
January 2010.
Publisher
Oxford University Press
Abstract
AimsIn patients with acute coronary syndromes (ACS), the negative impact
of baseline haemoglobin levels on ischaemic events, particularly death, is
well established, but the association with bleeding risk is less well
studied. The aim of this study was to assess the impact of baseline
haemoglobin levels on major bleeding complications.Methods and
resultsPooled analysis of OASIS 5 and 6 data involving 32 170 patients
with ACS with and without ST-segment elevation was performed. The
association between baseline haemoglobin and major bleeding or ischaemic
events was examined using multiple regression model. Main outcome measures
were 30-day rates of major bleeding, death, and death/myocardial
infarction (MI) analysed according to baseline haemoglobin levels.
Baseline haemoglobin level independently predicted the risk of overall,
procedure-related, and non-procedure-related major bleedings at 30 days
[odds ratio (OR) 0.94, 95 CI 0.90-0.98; OR 0.94, 95 CI 0.90-0.99; and OR
0.89, 95 CI 0.83-0.95, respectively, per 1 g/dL haemoglobin increment
above 10 g/dL]. In addition, a curvilinear relationship between baseline
haemoglobin levels and death at 30 days was observed with a 6 decrease in
the risk for every 1 g/dL haemoglobin increment above 10 g/dL up to 15.9
g/dL (OR 0.94, 95 CI 0.90-0.98) and a 19 increase above this value (OR
1.19, 95 CI, 0.98-1.43). A similar relationship for the composite outcome
of death/MI was observed.ConclusionA low baseline haemoglobin level is an
independent predictor of the risk of major bleeding in ACS as well as of
the risk of death and death and MI. Among other predictors of bleeding
risk, baseline haemoglobin should be taken into account in patients
presenting with ACS.Clinical trial registration: ClinicalTrials.gov
number, NCT00139815.http://clinicaltrials.gov/ct2/show/NCT00139815?term=
NCT00139815&rank=1.
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Accession Number
2010013112
Authors
Dew M.A. Dabbs A.D. Myaskovsky L. Shyu S. Shellmer D.A. Dimartini A.F.
Steel J. Unruh M. Switzer G.E. Shapiro R. Greenhouse J.B.
Institution
(Dew, Myaskovsky, Dimartini, Steel, Switzer) Department of Psychiatry,
University of Pittsburgh, School of Medicine, 3811 O'Hara St, Pittsburgh,
PA 15213, United States.
(Dew) Department of Biostatistics, University of Pittsburgh, Pittsburgh,
PA, United States.
(Dew) Department of Epidemiology, University of Pittsburgh, Pittsburgh,
PA, United States.
(Dew) Cardiothoracic Transplantation Program, University of Pittsburgh
Medical Center (UPMC), Pittsburgh, PA, United States.
(Dabbs) Department of Acute and Tertiary Care Nursing, University of
Pittsburgh, Pittsburgh, PA, United States.
(Myaskovsky, Unruh, Switzer) Department of Medicine, University of
Pittsburgh, Pittsburgh, PA, United States.
(Myaskovsky, Dimartini, Steel, Shapiro) Thomas E. Starzl Transplantation
Institute, UPMC, Pittsburgh, PA, United States.
(Shyu) University of Pittsburgh, School of Medicine, Pittsburgh, PA,
United States.
(Shellmer) Department of Pediatrics, University of Pittsburgh, Pittsburgh,
PA, United States.
(Shellmer) Hillman Center for Pediatric Transplantation, UPMC, Pittsburgh,
PA, United States.
(Dimartini, Steel, Shapiro) Department of Surgery, University of
Pittsburgh, Pittsburgh, PA, United States.
(Switzer) Center for Health. Equity Research and Promotion, Veterans
Administration Medical Center, Pittsburgh, PA, United States.
(Greenhouse) Department of Statistics, Carnegie Mellon University,
Pittsburgh, PA, United States.
Title
Meta-Analysis of medical regimen adherence outcomes in pediatric solid
organ transplantation.
Source
Transplantation. 88(5)(pp 736-746), 2009. Date of Publication: 15 Sep
2009.
Publisher
Lippincott Williams and Wilkins
Abstract
Background. Adherence to the medical, regimen after pediatric organ
transplantation is important for maximizing good clinical outcomes.
However, the literature provides inconsistent evidence regarding
prevalence and risk factors for nonadherence posttransplant. Methods. A
total of 61 studies (30 kidney, 18 liver, 8 heart, 2 lung/heart-lung, and
3 with mixed recipient samples) were included in a meta-analysis. Average
rates ofnonadherenee to six areas of the regimen, and correlations of
potential risk factors with nonadherence, were calculated. Results. Across
all types of transplantation, nonadherence to clinic appointments and
tests was most prevalent, at 12.9 cases per 100 patients per year (PPY).
The immunosuppression nonadherence rate was six cases per 100 PPY.
Nonadherence to substance use restrictions, diet, exercise, and other
healthcare requirements ranged from 0.6 to 8 cases per 100 PPY. Only the
rate of nonadherence to clinic appointments and tests varied by transplant
type: heart recipients had the lowest rate (4.6 cases per 100 PPY vs.
12.7-18.8 cases per 100 PPY in other recipients). Older age of the child,
family functioning (greater parental distress and lower family cohesion),
and the child's psychological status (poorer behavioral functioning and
greater distress) were among the psychosocial, characteristics
significantly correlated with poorer adherence. These correlations were
small to modest in size (r=0.12-0.18). Conclusions. These nonadherence
rates provide benchmarks for clinicians to use to estimate patient risk.
The identified psychosocial correlates of nonadherence are potential
targets for intervention. Future studies should focus on improving the
prediction of nonadherence risk and on testing interventions to reduce
risk. Copyright copyright 2009 by Lippincott Williams & Wilkins.
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Accession Number
2009652009
Authors
Garg S. Serruys P. Onuma Y. Dorange C. Veldhof S. Miquel-Hebert K. Sudhir
K. Boland J. Huber K. Garcia E. te Riele J.A.M.
Institution
(Garg, Serruys, Onuma) Thoraxcenter, Erasmus Medical Center, Rotterdam,
Netherlands.
(Dorange, Veldhof, Miquel-Hebert) Abbott Vascular, Diegem, Belgium.
(Sudhir) Abbott Vascular, Santa Clara, CA, United States.
(Boland) C.H.R. La Citadelle, Liege, Belgium.
(Huber) Wilhelminenspital der Stadt, Vienna, Austria.
(Garcia) University Hospital Gregorio Maranon, Madrid, Spain.
(te Riele) Amphia Hospital, Breda, Netherlands.
Title
3-Year Clinical Follow-Up of the XIENCE V Everolimus-Eluting Coronary
Stent System in the Treatment of Patients With De Novo Coronary Artery
Lesions. The SPIRIT II Trial (Clinical Evaluation of the Xience V
Everolimus Eluting Coronary Stent System in the Treatment of Patients with
de novo Native Coronary Artery Lesions).
Source
JACC: Cardiovascular Interventions. 2(12)(pp 1190-1198), 2009. Date of
Publication: December 2009.
Publisher
Elsevier Inc.
Abstract
Objectives: This paper reports the 3-year clinical outcomes of the XIENCE
V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent
(EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts)
paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical
Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the
Treatment of Patients with de novo Native Coronary Artery Lesions) study.
Background: The Xience V EES is a new-generation drug-eluting stent (DES)
that might offer advantages over the first-generation DES in terms of
improved clinical outcomes and a better safety profile. Methods: The
SPIRIT II trial was a multicenter, prospective, randomized, single-blind,
clinical trial, randomizing 300 patients with de novo coronary artery
lesions in a ratio of 3:1 to either EES or PES. The primary end point was
in-stent late loss at 180 days. Results: At 3-year clinical follow-up
cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p =
0.056). The observed rate of myocardial infarction was 3.6% for EES and
7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion
revascularization was 4.6% and 10.1% for EES and PES, respectively (p =
0.14). Overall, there was a trend for lower major adverse cardiovascular
events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The
rate of stent thrombosis was low and comparable in both groups (EES 1.0%
vs. PES 2.9%). Conclusions: The present study reports the favorable 3-year
clinical outcomes of the EES, which are consistent with the results from
other studies of the EES with shorter follow-up. copyright 2009 American
College of Cardiology Foundation.
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Accession Number
2009649996
Authors
Hachamovitch R. Johnson J.R. Hlatky M.A. Cantagallo L. Johnson B.H.
Coughlan M. Hainer J. Gierbolini J. Di Carli M.F.
Institution
(Cantagallo, Coughlan, Hainer, Gierbolini, Di Carli) Department of
Radiology, Harvard Medical School, Brigham and Women's Hospital, Boston,
MA, United States.
(Di Carli) Departments of Medicine and Radiology, Harvard Medical School,
Brigham and Women's Hospital, Boston, MA, United States.
(Hlatky) Departments of Health Research and Policy and of Medicine
(Cardiovascular Medicine), Stanford University, School of Medicine,
Stanford, CA, United States.
(Johnson, Johnson) SPARC Data Coordinating Center, Cary, NC, United
States.
(Hachamovitch) 6380 Wilshire Blvd, Los Angeles, CA 90048, United States.
Title
The study of myocardial perfusion and coronary anatomy imaging roles in
CAD (SPARC): Design, rationale, and baseline patient characteristics of a
prospective, multicenter observational registry comparing PET, SPECT, and
CTA for resource utilization and clinical outcomes.
Source
Journal of Nuclear Cardiology. 16(6)(pp 935-948), 2009. Date of
Publication: December 2009.
Publisher
Springer New York
Abstract
Objectives: To design a multicenter study comparing the prognostic value
and post-test resource utilization of PET, CT Coronary Angiography (CTA),
and SPECT in clinical practice. Background: Although PET, CTA, and SPECT
are widely used, their relative clinical- and cost-effectiveness are
undefined. Methods: The Study of Myocardial Perfusion and Coronary Anatomy
Imaging Roles in CAD (SPARC) is a prospective, multicenter, observational
registry that has enrolled 3019 patients undergoing clinically referred
SPECT, PET, and CTA with the goal of comparing post-test resource
utilization and comparative prognostic value. Resource utilization
assessment will enroll intermediate-high likelihood patients without prior
CAD, while prognostic assessment will include both these patients and
patients with prior CAD. Secondary analyses include assessments of
diagnostic accuracy, cost, and referral to revascularization. Sites
recruited into at least two of the three imaging arms. Except for
semi-quantitative interpretation, site protocols will be used for all
imaging studies and images forwarded to an image repository. Follow-up for
catheterization, revascularization, cardiac death, myocardial infarction,
all-cause death and medication use changes will be performed at 90-day, 1,
and 2 years. Standard statistical methods will be used to risk-adjust
results within and between study arms. SPARC will have >85% power
(two-sided test, alpha = 0.01) to detect a 5% catheterization rate
difference at 90 days between the three arms and >90% power to detect a 2%
difference in cardiac death, or nonfatal MI within 2 years of the index
test. Conclusions: SPARC will be the first study comparing outcomes and
resource utilization between SPECT, PET, and CTA in daily practice. In
addition, the study design offers insights into inter-site and geographic
differences in referral patterns and resource utilization. copyright 2009
American Society of Nuclear Cardiology.
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Accession Number
2010020870
Authors
Villari B. Sossalla S. Ciampi Q. Petruzziello B. Turina J. Schneider J.
Turina M. Hess O.M.
Institution
(Villari, Ciampi, Petruzziello) Division of Cardiology, Fatebenefratelli
Hospital of Benevento, Benevento, Italy.
(Sossalla, Hess) Department of Cardiology, Swiss Cardiovascular Center,
University Hospital, CH-3010 Bern, Switzerland.
(Turina, Schneider, Turina) Division of Cardiology and Cardiovascular
Surgery, University Hospital, Zurich, Switzerland.
Title
Persistent diastolic dysfunction late after valve replacement in severe
aortic regurgitation.
Source
Circulation. 120(23)(pp 2386-2392), 2009. Date of Publication: December
2009.
Publisher
Lippincott Williams and Wilkins
Abstract
BACKGROUND-Regression of left ventricular (LV) hypertrophy with
normalization of diastolic function has been reported in patients with
aortic stenosis late after aortic valve replacement (AVR). The purpose of
the present study was to evaluate the effect of AVR on LV function and
structure in chronic aortic regurgitation early and late after AVR.
METHODS AND RESULTS-Twenty-six patients were included in the present
analysis. Eleven patients with severe aortic regurgitation were studied
before, early (21 months) and late (89 months) after AVR through the use
of LV biplane angiograms, high-fidelity pressure measurements, and LV
endomyocardial biopsies. Fifteen healthy subjects were used as controls.
LV systolic function was determined from biplane ejection fraction and
midwall fractional shortening. LV diastolic function was calculated from
the time constant of LV relaxation, peak filling rates, and myocardial
stiffness constant. LV structure was assessed from muscle fiber diameter,
interstitial fibrosis, and fibrous content. LV muscle mass decreased
significantly by 38% early and 55% late after surgery. Ejection fraction
was significantly reduced preoperatively and did not change after AVR
(P=NS). LV relaxation was significantly prolonged before surgery (89+/-28
ms) but was normalized late after AVR (42+/-14 ms). Early and late peak
filling rates were increased preoperatively but normalized
postoperatively. Diastolic stiffness constant was increased before surgery
(22+/-6 versus 9+/-3 in control subjects; P=0.0003) and remained elevated
early and late after AVR (23+/-4; P=0.002). Muscle fiber diameter
decreased significantly after AVR but remained increased at late
follow-up. Interstitial fibrosis was increased preoperatively and
increased even further early but decreased late after AVR. Fibrosis was
positively linearly correlated to myocardial stiffness and inversely
correlated to LV ejection fraction. CONCLUSIONS-Patients with aortic
regurgitation show normalization of macroscopic LV hypertrophy late after
AVR, although fiber hypertrophy persists. These changes in LV myocardial
structure late after AVR are accompanied by a change in passive elastic
properties with persistent diastolic dysfunction. copyright 2009 American
Heart Association, Inc.
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Accession Number
2010004356
Authors
Baker W.L. Coleman C.I. Kluger J. Reinhart K.M. Talati R. Quercia R. Phung
O.J. White C.M.
Institution
(Baker, Coleman, Kluger, Reinhart, Talati, Quercia, Phung, White)
University of Connecticut, Hartford Hospital Evidence-based Practice
Center, 80 Seymour Street, Hartford, CT 06102-5037, United States.
Title
Systematic review: Comparative effectiveness of angiotensin-converting
enzyme inhibitors or angiotensin II-receptor blockers for ischemic heart
disease.
Source
Annals of Internal Medicine. 151(12)(pp 861-871), 2009. Date of
Publication: 15 Dec 2009.
Publisher
American College of Physicians
Abstract
Background: Patients with ischemic heart disease and preserved ventricular
function experience considerable morbidity and mortality despite standard
medical therapy. Purpose: To compare benefits and harms of using
angiotensin-converting enzyme (ACE) inhibitors, angiotensin II-receptor
blockers (ARBs), or combination therapy in adults with stable ischemic
heart disease and preserved ventricular function. Data Sources: MEDLINE,
EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane
Database of Systematic Reviews (earliest date, July 2009) were searched
without language restrictions. Study Selection: Two independent
investigators screened citations for trials of at least 6 months' duration
that compared ACE inhibitors, ARBs, or combination therapy with placebo or
active control and reported any of several clinical outcomes. Data
Extraction: Using standardized protocols, 2 independent investigators
extracted information about study characteristics and rated the quality
and strength of evidence. Disagreement was resolved by consensus. Data
Synthesis: 41 studies met eligibility criteria. Moderate- to high-strength
evidence (7 trials; 32 559 participants) showed that ACE inhibitors reduce
the relative risk (RR) for total mortality (RR, 0.87 [95% CI, 0.81 to
0.94]) and nonfatal myocardial infarction (RR, 0.83 [CI, 0.73 to 0.94])
but increase the RR for syncope (RR, 1.24 [CI, 1.02 to 1.52]) and cough
(RR, 1.67 [CI, 1.22 to 2.29]) compared with placebo. Low-strength evidence
(1 trial; 5926 participants) suggested that ARBs reduce the RR for the
composite end point of cardiovascular mortality, nonfatal myocardial
infarction, or stroke (RR, 0.88 [CI, 0.77 to 1.00]) but not for the
individual components. Moderate-strength evidence (1 trial; 25 620
participants) showed similar effects on total mortality (RR, 1.07 [CI,
0.98 to 1.16]) and myocardial infarction (RR, 1.08 [CI, 0.94 to 1.23]) but
an increased risk for discontinuations because of hypotension (P < 0.001)
and syncope (P = 0.035) with combination therapy compared with ACE
inhibitors alone. Limitations: Many studies either did not assess or did
not report harms in a systematic manner. Many studies did not adequately
report benefits or harms by various patient subgroups. Conclusion: Adding
an ACE inhibitor to standard medical therapy improves outcomes, including
reduced risk for mortality and myocardial infarctions, in some patients
with stable ischemic heart disease and preserved ventricular function.
Less evidence supports a benefit of ARB therapy, and combination therapy
seems no better than ACE inhibitor therapy alone and increases harms.
Primary Funding Source: Agency for Healthcare Research and Quality.
copyright 2009 American College of Physicians.
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Accession Number
2009627100
Authors
Urwyler N. Trelle S. Theiler L. Juni P. Staub L.P. Luyet C. Alberio L.
Stricker K. Greif R.
Institution
(Urwyler, Theiler, Luyet, Stricker, Greif) University Department of
Anesthesiology and Pain Therapy, University Hospital of Bern, Inselspital,
3010 Bern, Switzerland.
(Trelle, Juni) CTU Bern, Bern University Hospital and Institute of Social
and Preventive Medicine, University of Bern, Niesenweg 6, 3012 Bern,
Switzerland.
(Staub) NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77,
Camperdown NSW 1450, Australia.
(Alberio) University Department of Hematology, University Hospital of
Bern, Inselspital, 3010 Bern, Switzerland.
Title
Does point of care prothrombin time measurement reduce the transfusion of
fresh frozen plasma in patients undergoing major surgery? The POC-OP
randomized-controlled trial.
Source
Trials. 10, 2009. Article Number: 107. Date of Publication: 23 Nov 2009.
Publisher
BioMed Central Ltd.
Abstract
Background: Bleeding is a frequent complication during surgery. The
intraoperative administration of blood products, including packed red
blood cells, platelets and fresh frozen plasma (FFP), is often live
saving. Complications of blood transfusions contribute considerably to
perioperative costs and blood product resources are limited. Consequently,
strategies to optimize the decision to transfuse are needed.
Methods/Design: Bleeding during surgery is a dynamic process and may
result in major blood loss and coagulopathy due to dilution and
consumption. The indication for transfusion should be based on reliable
coagulation studies. While hemoglobin levels and platelet counts are
available within 15 minutes, standard coagulation studies require one
hour. Therefore, the decision to administer FFP has to be made in the
absence of any data. Point of care testing of prothrombin time ensures
that one major parameter of coagulation is available in the operation
theatre within minutes. It is fast, easy to perform, inexpensive and may
enable physicians to rationally determine the need for FFP. Discussion:
The objective of the POC-OP trial is to determine the effectiveness of
point of care prothrombin time testing to reduce the administration of
FFP. It is a patient and assessor blind, single center randomized
controlled parallel group trial in 220 patients aged between 18 and 90
years undergoing major surgery (any type, except cardiac surgery and liver
transplantation) with an estimated blood loss during surgery exceeding 20%
of the calculated total blood volume or a requirement of FFP according to
the judgment of the physicians in charge. Patients are randomized to usual
care plus point of care prothrombin time testing or usual care alone
without point of care testing. The primary outcome is the relative risk to
receive any FFP perioperatively. The inclusion of 110 patients per group
will yield more than 80% power to detect a clinically relevant relative
risk of 0.60 to receive FFP of the experimental as compared with the
control group. Trial registration: Point of care prothrombin time testing
in the operation theatre may reduce the administration of FFP
considerably, which in turn may decrease costs and complications usually
associated with the administration of blood products. NCT00656396.
copyright 2009 Urwyler et al; licensee BioMed Central Ltd.
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