Randomization of Single vs Multiple Arterial Grafts (ROMA)
Daniel Engelman, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.
Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.
Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
• Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
• Age > 70 years
• Single graft
• Emergency operation
• Evolving myocardial infarction within 48 hours of surgery
• Left ventricular ejection fraction of < 35%
• Any concomitant cardiac or non-cardiac procedure
• Previous cardiac surgery
• Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
• Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
• Anticipated need for coronary thrombo-endarterectomy
• Planned hybrid revascularization
Interventional (Clinical Trial), Randomized