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

Summary

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

Interventions

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.

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.

Sponsors & Collaborators

• New York Presbyterian Hospital

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Mario Gaudino, Prof/PhD/MD · Weill Medical College of Cornell University

• Stephen Fremes, MD · Sunnybrook Health Sciences Centre

• Ruth Masterson Creber, RN, PhD · Columbia University

• C. Noel Bairey Merz, MD · Cedars-Sinai

• Karla Ballman, PhD · Weill Medical College of Cornell University

• Sean O'Brien, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2030-03-31

Completion

2030-03-31

Countries

• United States
• Australia
• Austria
• Brazil
• Canada
• China
• Croatia
• Czechia
• Denmark
• Germany
• India
• Israel
• Italy
• Japan
• Netherlands
• North Macedonia
• Poland
• Portugal
• Russia
• Serbia
• Singapore
• South Korea
• Spain
• Sweden
• Taiwan
• United Kingdom

Study Locations