2/2- randomized comparison of the outcomes of single VS multiple arterial grafts trial in women (roma:women)

Icahn School of Medicine at Mount Sinai received a $770,844 Cooperative Agreement from the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837) awarded on September 15, 2025. The award funds the ROMA:WOMEN trial, the first randomized controlled study exclusively enrolling women to compare outcomes of multiple arterial grafts (MAG) versus single arterial grafts (SAG) in coronary artery bypass grafting (CABG) procedures. The trial will enroll 2,000 women randomized 1:1 to MAG or SAG arms and track major adverse cardiac and cerebrovascular events at a minimum 2.5-year follow-up, with a target of greater than 90% statistical power to demonstrate a 25% relative risk reduction in the primary composite outcome.

The study leverages existing infrastructure from the broader ROMA trial, including the clinical trial database, randomization systems, regulatory approvals, and network of participating sites. Secondary outcomes will assess generic and disease-specific quality of life measures using validated instruments including the Seattle Angina Questionnaire (SAQ), SF-12, EQ-5D, and PROMIS-29 assessments at 12 months post-baseline. The performance period extends through August 31, 2030, with the trial being conducted at the awardee's location in New York, NY.

Abstract

Coronary artery bypass grafting (cabg) is the most common 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. Women represent a minority of patients in cabg trials, and there are important biological and surgical differences between men and women undergoing cabg roma:women is the first trial comparing arterial VS. Venous graft in a exclusive women population. In a rigorous randomized trial that focus enrollment exclusively in women we will 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. We will enroll 2,000 women randomized 1:1 to MAG or SAG. Roma:women will leverage the existing infrastructure of roma (conducted on both women and men) including the clinical trial database, case report forms, randomization system, site training resources, regulatory approvals, network of participating sites, and study coordinators. The trial primary outcome will be a composite of 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 will be the absolute changes 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.