The Best Bypass Surgery Trial: rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting.
BACKGROUND
Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have additional benefit from OPCAB.


METHODS
The Best Bypass Surgery Trial is a randomized, single center trial comparing the effects of OPCAB versus CCAB. The inclusion criteria are 3 vessel coronary heart disease affecting one of the marginal arteries, age>54 years, and EuroSCORE>or=5. The primary composite outcome measure consists of all-cause mortality, myocardial infarction, stroke, cardiac arrest, cardiogenic shock, and cardiac revascularization procedure. Follow up involves collection of data of mortality and morbidity via linkage to public registers, quality of life assessment at 3 and 12 months postoperatively and angiographic control at 12 months. The sample size of 330 patients was based on an estimated 75% one-year event free rate of the primary outcome measure in the OPCAB arm and 60% in the control arm with alpha=.05 and beta=.20. Accordingly, the trial will be able to detect an absolute risk reduction of 15% or a relative risk reduction of 37.5%. The median follow-up time is scheduled to 3 years.


RESULTS
Enrollment started in April 2002 and ended March 2006.


CONCLUSIONS
The results may have implications on the treatment modality of moderate- to high-risk patients scheduled for coronary artery bypass grafting.
Møller
Christian H
CH
Department of Cardiothoracic Surgery, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. christian.01.moeller@rh.hosp.dk
Jensen
Birte Østergaard
BØ
Gluud
Christian
C
Perko
Mario J
MJ
Lund
Jens T
JT
Andersen
Lars Willy
LW
Madsen
Jan Kyst
JK
Hughes
Pia
P
Steinbrüchel
Daniel A
DA
D000368:Aged; D002315:Cardiopulmonary Bypass; D002423:Cause of Death; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D047549:Coronary Artery Bypass, Off-Pump; D003718:Denmark; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications / Q000401:mortality; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method