Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Purpose
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.
Conditions
- Heart Diseases
- Coronary Artery Disease
- Coronary Artery Bypass Grafting
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Women patients ≥18 years old. 2. Isolated coronary artery bypass grafting. 3. Primary (first time) cardiac surgery procedure. 4. 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.
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The endpoint assessors will be blinded to treatment allocation (PROBE).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single Arterial Graft (SAG) group |
Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts. |
|
|
Experimental Multiple Arterial Graft (MAG) group |
Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery. |
|
Recruiting Locations
Los Angeles, California 90048
Joanna Chikwe, MD
Pomona, California 91767
Christine Montesa, MD
San Francisco, California 94118
Elaine Tseng, MD
Aurora, Colorado 80045
Jessica Rove, MD
Hartford, Connecticut 06106
David Yaffee, MD
New Haven, Connecticut 06510
Roland Assi, MD
Atlanta, Georgia 30322
Alison Ward, MD
Chicago, Illinois 60637
Hasam Balkhy, MD
Iowa City, Iowa 52242
Mohammad Bashir, MD
Baltimore, Maryland 21218
Jennifer Lawton, MD
Springfield, Massachusetts 01199
Daniel Engelman, MD
Worcester, Massachusetts 01655
Leora Balsam, MD
Ann Arbor, Michigan 48104
Robert Hawkins, MD
Royal Oak, Michigan 48073
Thomas Schwann, MD
St Louis, Missouri 63110
Puja Kachroo, MD
Omaha, Nebraska 68118
HelenMari Merritt-Genore, DO
Omaha, Nebraska 68198
Aleem Siddique, MD
Englewood, New Jersey 07631
Molly Schultheis, MD
Newark, New Jersey 07112
Arash Salemi, MD
Ridgewood, New Jersey 07450
Juan B Grau, MD
Brooklyn, New York 11215
Sandhya Balaram, MD
New York, New York 10021
New York, New York 10032
Koji Takeda, MD
Queens, New York 11355
Charles Mack, MD
Durham, North Carolina 27710
Brittany Zwischenberger, MD
Greenville, North Carolina 27858
Benjamin Degner, MD
Winston-Salem, North Carolina 27106
Bart Imielski, MD
Columbus, Ohio 43210
Jovan Bozinovski, MD
Zanesville, Ohio 43701
Trevor Ellison, MD
Philadelphia, Pennsylvania 19104
Marisa Cevasco, MD
Wynnewood, Pennsylvania 19096
Gianluca Torregrossa, MD
Providence, Rhode Island 02903
Afshin Efsan, MD
Dallas, Texas 75204
Michael DiMaio, MD
Galveston, Texas 77550
Abe DeAnda, MD
Houston, Texas 77030
Lauren Barron, MD
San Antonio, Texas 78229
Dawn Hui, MD
Salt Lake City, Utah 84132
Sara Pereira, MD
More Details
- Status
- Recruiting
- Sponsor
- Weill Medical College of Cornell University
Detailed Description
ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, 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. In Aim 2, 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. Differences by important 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. ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial. ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.