Document Detail


Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery.
MedLine Citation:
PMID:  22172429     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart (off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relatively short follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- and long-term impact of the 2 approaches to CABG.
METHODS: We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or off pump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at 30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will also undertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitive dysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life.
RESULTS: As of May 3, 2011, CORONARY has recruited >3,884 patients from 79 centers in 19 countries. Currently, patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and 34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triple vessel disease.
CONCLUSIONS: CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its results will lead to a better understanding of the safety and efficacy of off-pump CABG.
Authors:
Andre Lamy; Philip J Devereaux; Dorairaj Prabhakaran; Shengshou Hu; Leopoldo S Piegas; Zbynek Straka; Ernesto Paolasso; David Taggart; Fernando Lanas; A Ruchan Akar; Anil Jain; Nicolas Noiseux; Yongning Ou; Susan Chrolavicius; Jennifer Ng; Salim Yusuf
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  163     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-16     Completed Date:  2012-02-10     Revised Date:  2012-04-06    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-6     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Mosby, Inc. All rights reserved.
Affiliation:
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Canada. lamya@mcmaster.ca
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00463294
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MeSH Terms
Descriptor/Qualifier:
Aged
Coronary Artery Bypass / adverse effects,  economics,  methods*
Coronary Artery Bypass, Off-Pump / adverse effects,  economics,  methods
Cost-Benefit Analysis
Disease-Free Survival
Female
Humans
Male
Middle Aged
Myocardial Infarction / mortality
Patient Selection
Postoperative Complications / mortality*
Renal Insufficiency / mortality
Research Design
Stroke / mortality
World Health
Grant Support
ID/Acronym/Agency:
//Canadian Institutes of Health Research

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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