Rationale and design of The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization Study: A large international randomized trial in cardiac surgery - 14/12/11
, Philip J. Devereaux, MD, PhD a, m, Dorairaj Prabhakaran, MD, DM b, m, Shengshou Hu, MSc, MD c, m, Leopoldo S. Piegas, MD, PhD d, m, Zbynek Straka, MD, PhD e, m, Ernesto Paolasso, MD f, m, David Taggart, MD, FRCS CTh, PhD g, m, Fernando Lanas, MD, MSc h, m, A. Ruchan Akar, MD, FRCS CTh i, m, Anil Jain, MD, DNB j, m, Nicolas Noiseux, MD k, m, Yongning Ou, MSc, MD l, m, Susan Chrolavicius, BA, RN l, m, Jennifer Ng, MSc l, m, Salim Yusuf, DPhil a, mRésumé |
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.
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| RCT reg number 00463294. |
Vol 163 - N° 1
P. 1-6 - janvier 2012 Retour au numéro
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