Randomization of Single vs Multiple Arterial Grafts

Summary

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Conditions

• Coronary Artery Disease
• Heart Diseases

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

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

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

• Stephen Fremes, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-07

Primary Completion

2027-06-30

Completion

2030-01-01

Countries

• United States
• Austria
• Brazil
• Canada
• China
• Croatia
• Czechia
• Germany
• Italy
• Japan
• Netherlands
• Poland
• Portugal
• Serbia
• Singapore
• South Korea
• Spain

Study Locations