Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Weill Medical College of Cornell University
Summary
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.
Description
In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending (LAD) was grafted with a left internal thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at least in part, due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts (SVG) (2). For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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-m…
Interventions
- ProcedureSingle arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
- ProcedureMultiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
Locations (59)
- University of ColoradoBoulder, Colorado
- Baystate HealthSpringfield, Massachusetts
- Nebraska Heart HospitalLincoln, Nebraska
- University of Nebraska Medical CenterOmaha, Nebraska
- NewYork-Presbyterian Brooklyn Methodist HospitalBrooklyn, New York
- Icahn School of Medicine, Mount SinaiNew York, New York