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, like a detour (bypass). Leg veins (saphenous veins) are used for most of the bypasses. Survival, prevention of further heart attacks and relief of angina are 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 most commonly performed coronary bypass operation. It has also been assumed 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 following the standard operation. Yet this viewpoint is largely based on scientifically weak evidence, rather than randomized clinical trials. ROMA is an international, multicentre randomized clinical trial of 4300 patients with extended follow-up 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 pilot phase of the study of 430 patients is currently underway with CIHR funding to determine the viability of the project prior to commitment to the full study. As of July 31, 2018, 380 patients have been enrolled - we predict that the pilot phase will be completed in October 2018. The pilot phase is on target in terms of the timelines and the stated pilot phase objectives and strongly supports the viability of the project. This submission is to fund the definitive phase of the study, i.e. complete the total study enrollment and extend the patient follow-up (up to 7 years) to determine with confidence if the multiple arterial grafting approach is better for patients.