Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

What this study is about

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Who can join (things the study team will check)

✅ You may be able to join if…

• Women patients ≥18 years old.
• Isolated coronary artery bypass grafting.
• Primary (first time) cardiac surgery procedure.
• Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

🚫 You may not be able to join if…

• Male gender
• Single graft
• Emergency operation
• Myocardial infarction within 72 hours of surgery
• Left ventricular ejection fraction < 35%
• Any concomitant cardiac or non-cardiac procedure
• Previous cardiac surgery
• Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
• Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
• Anticipated need for coronary thrombo-endarterectomy
• Planned hybrid revascularization

Where this trial is running

• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Pomona Valley Hospital Medical Center, Pomona, California, United States
• University of California, San Francisco, San Francisco, California, United States
• University of Colorado, Aurora, Colorado, United States
• Hartford Hospital, Hartford, Connecticut, United States
• Yale University Hospital, New Haven, Connecticut, United States
• Emory University, Atlanta, Georgia, United States
• University of Chicago, Chicago, Illinois, United States
• Indiana University, Indianapolis, Indiana, United States
• University of Iowa, Iowa City, Iowa, United States
• Johns Hopkins University, Baltimore, Maryland, United States
• Baystate Health, Springfield, Massachusetts, United States

+ 134 more sites.

Who to contact

Mario Gaudino, Prof/PhD/MD · 212.746.1812 · mfg9004@med.cornell.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04124120.