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

  1. 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

ArmDescriptionAssigned 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.
  • Procedure: Single arterial graft
    This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
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.
  • Procedure: Multiple arterial grafting
    This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

Recruiting Locations

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Contact:
Joanna Chikwe, MD

Pomona Valley Hospital Medical Center
Pomona 5384170, California 5332921 91767
Contact:
Christine Montesa, MD

University of California, San Francisco
San Francisco 5391959, California 5332921 94118
Contact:
Elaine Tseng, MD

University of Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Jessica Rove, MD

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06106
Contact:
David Yaffee, MD

Yale University Hospital
New Haven 4839366, Connecticut 4831725 06510
Contact:
Roland Assi, MD

Emory University
Atlanta 4180439, Georgia 4197000 30322
Contact:
Alison Ward, MD

University of Chicago
Chicago 4887398, Illinois 4896861 60637
Contact:
Hasam Balkhy, MD

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Mohammad Bashir, MD

Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21218
Contact:
Jennifer Lawton, MD

Baystate Health
Springfield 4951788, Massachusetts 6254926 01199
Contact:
Daniel Engelman, MD

University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Leora Balsam, MD

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48104
Contact:
Robert Hawkins, MD

Corewell Health William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Thomas Schwann, MD

Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Puja Kachroo, MD

Methodist Physicians Health
Omaha 5074472, Nebraska 5073708 68118
Contact:
HelenMari Merritt-Genore, DO

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Contact:
Aleem Siddique, MD

Englewood Health
Englewood 5097672, New Jersey 5101760 07631
Contact:
Molly Schultheis, MD

Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760 07112
Contact:
Arash Salemi, MD

The Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450
Contact:
Juan B Grau, MD

NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn 5110302, New York 5128638 11215
Contact:
Sandhya Balaram, MD

Weill Cornell Medicine
New York 5128581, New York 5128638 10021
Contact:
Mario Gaudino, Prof/PhD/MD
212-746-1812
mfg9004@med.cornell.edu

Columbia University Medical Center
New York 5128581, New York 5128638 10032
Contact:
Koji Takeda, MD

New York Presbyterian Queens
Queens 5133273, New York 5128638 11355
Contact:
Charles Mack, MD

Duke University
Durham 4464368, North Carolina 4482348 27710
Contact:
Brittany Zwischenberger, MD

East Carolina University
Greenville 4469160, North Carolina 4482348 27858
Contact:
Benjamin Degner, MD

Wake Forest University
Winston-Salem 4499612, North Carolina 4482348 27106
Contact:
Bart Imielski, MD

Ohio State University
Columbus 4509177, Ohio 5165418 43210
Contact:
Jovan Bozinovski, MD

Genesis Healthcare System
Zanesville 4528923, Ohio 5165418 43701
Contact:
Trevor Ellison, MD

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Marisa Cevasco, MD

Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19096
Contact:
Gianluca Torregrossa, MD

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
Contact:
Afshin Efsan, MD

Baylor Scott & White Research Institute
Dallas 4684888, Texas 4736286 75204
Contact:
Michael DiMaio, MD

The University of Texas Medical Health Branch at Galveston
Galveston 4692883, Texas 4736286 77550
Contact:
Abe DeAnda, MD

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Contact:
Lauren Barron, MD

UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Dawn Hui, MD

University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Contact:
Sara Pereira, MD

More Details

Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

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

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.