title: Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery.
abstract: 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.affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University, Canada. lamya@mcmaster.ca
authors.forename: Andre
authors.initials: A
authors.lastname: Lamy
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: Dorairaj
authors.initials: D
authors.lastname: Prabhakaran
authors.forename: Shengshou
authors.initials: S
authors.lastname: Hu
authors.forename: Leopoldo S
authors.initials: LS
authors.lastname: Piegas
authors.forename: Zbynek
authors.initials: Z
authors.lastname: Straka
authors.forename: Ernesto
authors.initials: E
authors.lastname: Paolasso
authors.forename: David
authors.initials: D
authors.lastname: Taggart
authors.forename: Fernando
authors.initials: F
authors.lastname: Lanas
authors.forename: A Ruchan
authors.initials: AR
authors.lastname: Akar
authors.forename: Anil
authors.initials: A
authors.lastname: Jain
authors.forename: Nicolas
authors.initials: N
authors.lastname: Noiseux
authors.forename: Yongning
authors.initials: Y
authors.lastname: Ou
authors.forename: Susan
authors.initials: S
authors.lastname: Chrolavicius
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ng
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D047549:Coronary Artery Bypass, Off-Pump / Q000009:adverse effects / Q000191:economics / Q000379:methods; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D005260:Female; D014943:Global Health; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality; D018579:Patient Selection; D011183:Postoperative Complications / Q000401:mortality*; D051437:Renal Insufficiency / Q000401:mortality; D012107:Research Design; D020521:Stroke / Q000401:mortality