Grant: Project Grant

Coronary artery bypass surgery is an operation to improve the circulation of the heart where healthy blood vessels from the patients are used to go around blockages caused by hardening of the arteries (atherosclerosis), like a detour (bypass). Leg veins (saphenous veins) are used for most of the bypasses. It is well established that survival, prevention of further heart attacks and relief of angina is improved following coronary surgery when a chest wall artery (left internal thoracic artery) is used for one of the bypasses rather than using leg veins for all the bypasses; this is the coronary bypass operation that is most commonly performed. It has generally been accepted that patients with an otherwise long anticipated life expectancy who receive a second chest wall artery (right internal thoracic artery) or an artery from the arm (radial artery) have better cardiac outcomes than patients who had the standard operation. That viewpoint has largely been based on poorly controlled studies rather than well conducted randomized clinical trials (where the treatment is determined by chance, like flipping a coin). In fact, in the largest randomized trial to date, the cardiac outcomes of patients who had two chest wall arteries were identical to those who had the standard operation, challenging this widely held point of view. ROMA is a randomized clinical trial designed to address whether the use of two or more bypass grafts using arteries from the chest wall or the arm improves outcomes compared to the standard operation late after coronary surgery. The study will be international, multicentre, and involve 4300 patients in total with extended follow-up after surgery, to be highly confident afterwards that the use of two or more arterial grafts does or does not improve important cardiac outcomes. The study will likely be challenging to complete - this submission is to enroll 430 patients to determine whether the study can likely be accomplished.