Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts the ROMA Trial

What this Trial Is About

Researchers are studying patients with coronary artery disease undergoing primary isolated non-emergency coronary artery bypass surgery CABG. The trial compares the use of a single arterial graft versus multiple arterial grafts to assess whether multiple grafts reduce the combined risk of death, stroke, heart attack after discharge, and repeat revascularization, as well as improve overall survival. This international randomized trial involves over 4,300 patients across at least 25 centers and aims to provide clear evidence on the benefits of arterial graft strategies in heart surgery. Participants will be randomly assigned to one of two groups. The first group receives a single arterial graft using the left internal thoracic artery, supplemented by venous grafts as needed. The second group receives multiple arterial grafts, including the left internal thoracic artery plus either the right internal thoracic artery or the radial artery, with the possibility of additional arterial grafts. Treatment is delivered during CABG surgery, and patients are followed over time to observe outcomes. During the study, participants will be monitored for major events such as death, stroke, heart attacks, and the need for additional procedures. Researchers will track these primary outcomes starting 72 hours after surgery and also evaluate secondary outcomes like 30-day mortality, postoperative complications, wound healing, stroke, cause-specific deaths, and hospital readmissions over a follow-up period that may average five years. The trial uses a randomized design to fairly compare the two grafting approaches and includes detailed safety and outcome assessments throughout the study period.

Randomization of Single vs Multiple Arterial Grafts