Grant: Project Grant

Coronary artery bypass grafting (CABG) 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). It has been shown that survival, prevention of further heart attacks and relief of angina are improved following CABG when a chest wall artery (left internal thoracic artery) is used for one of the bypasses rather than using leg veins (saphenous veins) for all the bypasses. It is generally believed 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) in addition to the single chest wall artery have better cardiac outcomes. Yet this viewpoint is largely based on scientifically weak evidence, rather than randomized clinical trials. Also, the standard operation continues to be using the left internal thoracic artery for one of the bypasses and saphenous veins for all other bypasses - the saphenous vein continues to be the most used bypass graft. ROMA is a randomized clinical trial funded from CIHR (April 2018 - March 2026) 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 CABG. This international study completed enrollment in April 2023 (>4300 patients). This submission entitled ROMA-ES (ROMA Extended Survival) is to continue the follow-up of the enrolled patients and not for additional patient recruitment. Based on the original planning and patient outcomes to date, we anticipate that further follow-up until 08/27 will be necessary to convincingly determine whether multiple arterial grafting is associated with fewer cardiovascular events (the primary study outcome) and until 2030/31 to assess whether there is a reduction in mortality (the key secondary study outcome) following isolated CABG.