Randomization of Single vs Multiple Arterial Grafts

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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

Where this trial is running

• University of Colorado, Boulder, Colorado, United States
• Baystate Health, Springfield, Massachusetts, United States
• Nebraska Heart Hospital, Lincoln, Nebraska, United States
• University of Nebraska Medical Center, Omaha, Nebraska, United States
• NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States
• Icahn School of Medicine, Mount Sinai, New York, New York, United States
• Weil Cornell Medical College Department of Cardiothoracic Surgery, New York, New York, United States
• Lenox Hill Hospital (Northwell), New York, New York, United States
• NewYork-Presbyterian Queens, New York, New York, United States
• Cleveland Clinic Foundation, Cleveland, Ohio, United States
• Allegheny General Hospital (Cardiovascular Institute), Pittsburgh, Pennsylvania, United States
• Innsbruck (Medical University) Austria, Innsbruck, Austria

+ 47 more sites.

Who to contact

Mario Gaudino, MD · 212.746.1812 · mfg9004@med.cornell.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03217006.