1/2 Randomized comparison of the Outcomes of single vs Multiple Arterial grafts trial in Women (ROMA:Women)

About This Grant

Project Summary / Abstract Coronary artery bypass grafting (CABG) is the most commonly performed adult cardiac surgery procedure, and the standard of care for patients with severe coronary artery disease. CABG can be performed using either arterial or venous grafts, with arterial grafts being associated with better outcomes in observational studies, but not in the only published randomized trial. The Randomized comparison of the Outcomes of single vs Multiple Arterial grafts (ROMA) trial will evaluate whether multiple arterial grafts (MAG) compared with single arterial graft (SAG) have better outcomes in the general CABG population (84.5% men). Women represent a minority of patients in CABG trials, and there are important biological and surgical differences between men and women undergoing CABG, so that ROMA as currently funded will not allow a meaningful assessment of the effect of MAG in women. However, ROMA provides a unique opportunity to leverage the existing trial infrastructure to realize the first cardiac surgery trial dedicated to women (ROMA:Women). By enrolling 2,000 women, we will have enough statistical power to determine 1) the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing CABG and 2) the impact of MAG vs SAG on generic and disease-specific quality of life (QOL) as well as physical and mental health symptoms in women undergoing CABG. Enrolled patients are randomized 1:1 to MAG or SAG. The inclusion and exclusion criteria, the interventions, outcome definitions and the follow-up protocol are identical to those of the ROMA trial. The only exception is that the 70 years age cut-off that was used in ROMA and will not be used in ROMA:Women. ROMA:Women leverages the existing ROMA infrastructure including clinical trial unit, database, case report forms, randomization system, site training resources, regulatory approvals, network of participating sites, and study coordinators. The trial primary outcome is a composite including death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure at a minimum follow-up of 2.5 years. The secondary outcome is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline. The trial is designed to have >90% power to demonstrate a 25% relative risk reduction in the primary composite outcome in the MAG group. Generic QOL (SF-12, EQ-5D), and symptoms (PROMIS-29) as well as key clinical events will also be captured.