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<1>
Accession Number
2014479378
Authors
Rogers C.A. Pike K. Campbell H. Reeves B.C. Angelini G.D. Gray A. Altman
D.G. Miller H. Wells S. Taggart D.P.
Institution
(Rogers, Pike, Reeves, Miller, Wells) Clinical Trials and Evaluation Unit,
School of Clinical Sciences, University of Bristol, Bristol, United
Kingdom
(Campbell, Gray) Health Economics Research Centre, Nuffield Department of
Population Health, University of Oxford, Oxford, United Kingdom
(Angelini) Bristol Heart Institute, School of Clinical Sciences,
University of Bristol, Bristol, United Kingdom
(Altman) Centre for Statistics in Medicine, University of Oxford, Oxford,
United Kingdom
(Taggart) Nuffield Department of Surgical Science, University of Oxford,
Oxford, United Kingdom
Title
Coronary artery bypass grafting in high-RISk patients randomised to off-
or on-pump surgery: A randomized controlled trial (the CRISP trial).
Source
Health Technology Assessment. 18 (44) (pp 1-157), 2014. Date of
Publication: 2014.
Publisher
NIHR Journals Library
Abstract
Background: Coronary artery bypass grafting (CABG) is the treatment of
choice for patients with multivessel coronary artery disease (CAD).
Evidence from randomised controlled trials (RCTs) in low-risk populations
shows that 'off-pump' CABG is at least as safe as 'on-pump' CABG, but
high-quality trial data in high-risk populations are lacking. Objectives:
To test the hypothesis that, in high-risk patients, off-pump coronary
artery bypass grafting (OPCABG) reduces mortality and morbidity without
causing a higher risk of reintervention compared with on-pump coronary
artery bypass grafting (ONCABG). Design: Open parallel-group RCT with a 1:
1 allocation ratio and expertise-based randomisation. Setting: Eight
specialist cardiac surgery centres in the UK and one specialist centre in
Kolkata, India. Participants: Patients with an additive European system
for cardiac operative risk evaluation score (EuroSCORE) of > 5, undergoing
non-emergency isolated CABG via a median sternotomy. Interventions: CABG
without cardiopulmonary bypass (CPB), i.e. OPCABG on the beating heart, or
CABG with CPB, i.e. ONCABG on a chemically arrested heart. Main outcome
measures: Primary outcome - a composite of death or serious morbidity
[all-cause mortality, myocardial infarction (MI), stroke, prolonged
initial ventilation, sternal wound dehiscence] within 30 days of surgery.
Secondary outcomes - quality of life (QoL) [Rose Angina Questionnaire,
Canadian Cardiovascular Society (CCS) angina class, European QoL-5
Dimensions (EQ-5D), Coronary Revascularisation Outcome Questionnaire
(CROQ)] and resource utilisation. Results: The organisation of a tertiary
cardiac surgery service in the UK presented several barriers to
recruitment. Referral information was often inadequate to confirm
eligibility. Limited surgeon participation at a centre, the need to meet
referral-to-treatment performance targets and complex referral pathways
did not support an expertise-based allocation. Urgent patients waiting for
surgery in local 'feeder' hospitals were often not transferred until late
the night before surgery, which limited the time available to take consent
and organise the surgery on an expertise basis. Several elective patients
declined to take part because they wanted the surgeon they had met when
the surgery was first discussed in clinic to operate. Several initiatives
were explored to boost recruitment. After 10 months of recruitment, the
trial design was modified to permit both within-surgeon and
expertise-based randomisation within a centre. However, this did not have
sufficient impact and the trial was stopped on the grounds of futility
after 106 patients (< 2% of the target sample size) had been recruited in
18 months. Ninety-eight patients were included in the trial analyses, six
patients were withdrawn and two died before surgery. In both groups, 6% of
patients experienced the primary outcome [adjusted odds ratio (OR) (OPCABG
to ONCABG) 1.07; 95% confidence interval (CI) 0.27 to 4.14]. QoL scores at
4-8 weeks post surgery were similar in the two groups. Patients randomised
to OPCABG had a shorter stay in the intensive care unit and in hospital
after surgery (median 26.0 vs. 27.7 hours in intensive care and 7 vs. 8
days in hospital). Conclusions: The Coronary artery bypass grafting in
high-RISk patients randomised to off- or on-Pump surgery (CRISP) trial was
not successful for a range of logistical reasons. However, the experience
gained is of value for the design and conduct of future trials. The
surgical community have polarised views. A qualitative evaluation of the
reasons behind the views held by the advocates of the two techniques is an
area for future research. Trial registration: Current Controlled Trials
ISRCTN29161170. Funding: This project was funded by the Medical Research
Council/National Institute for Health Research (NIHR) Efficacy and
Mechanism Evaluation programme and will be published in full in Health
Technology Assessment; Vol. 18, No. 44. See the NIHR Journals Library
website for further project information. Queen'S Printer and Controller
of HMSO 2014.
<2>
Accession Number
2014478691
Authors
Yang R.-Q. Wang L. Huang Q.-Y. Jiang X.-H. Wu Y.-Q. Hong K. Wu Q.-H. Cheng
X.-S.
Institution
(Yang, Huang, Jiang, Wu, Hong, Wu, Cheng) Department of Cardiology, Second
Affiliated Hospital, Nanchang University, 1st Minde road, Nanchang, China
(Wang) Laboratory of Biochemistry, Second Affiliated Hospital, Nanchang
University, Nanchang, China
Title
Invasive management of acute coronary syndrome in patients end-stage renal
disease: A meta-analysis.
Source
Experimental and Clinical Cardiology. 20 (6) (pp 145-159), 2014. Date of
Publication: 2014.
Publisher
Cardiology Academic Press
Abstract
The objective was to obtain evidence on the effectiveness of invasive
management by comparing mortality rates between patients with end-stage
renal disease (ESRD; Stage V CKD) who received invasive vs non-invasive
management of ACS. Medline, The Cochrane Library, EMBASE, and Google
Scholar were searched to identify studies involving patients with ACS and
ESRD (Stage V CKD) that compared outcomes for invasive (percutaneous
coronary intervention or coronary artery bypass grafting) vs non-invasive
(pharmaceutical) management of ACS. The outcomes of interest were the
short-term (< 1 month) and 1-year mortality rates. A total of 3 studies,
involving 593 patients who received invasive management and 2698 patients
who received non-invasive management, were included in the meta-analysis.
It revealed that the short-term mortality rate was significantly lower for
patients who received invasive management compared with patients who
received non-invasive management (OR: 0.69; 95% CI: 0.53 to 0.90; P =
0.006). Likewise, the 1-year mortality rate was significantly lower for
patients who received invasive management compared with patients who
received non-invasive management (OR: 0.61; 95% CI: 0.42 to 0.88; P =
0.008). The results of our meta-analysis suggest that patients of ACS
comorbidity with ESRD may benefit from invasive rather than non-invasive
management.
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