Randomization of Single vs Multiple Arterial Grafts

  • STATUS
    Recruiting
  • End date
    Jan 1, 2030
  • participants needed
    4300
  • sponsor
    Weill Medical College of Cornell University
Updated on 28 May 2021
Investigator
Mario F Gaudino, MD
Primary Contact
Saitama Medical University (9.6 mi away) Contact
+56 other location
stroke
myocardial infarction
infarct
bypass graft
bypass surgery
revascularisation

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.

Description

In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending (LAD) was grafted with a left internal thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at least in part, due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts (SVG) (2).

For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased postoperative survival compared to those who receive only one AG, especially over the long term (3-5). The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy (6, 7). Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs (8).

The putative mechanism underlying the AG hypothesis is greater patency. In line with the original findings of improved LAD graft patency with ITA vs. SVG, data from randomized control trials (RCTs) as well as observational studies and a network meta-analysis (9) have demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG, providing mechanistic basis to support the AG hypothesis.

ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.

The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs 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 aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival.

Details
Condition Coronary Artery Disease, Coronary heart disease, Heart disease, Cardiovascular Disease, Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder
Treatment Single arterial graft, Multiple arterial grafting
Clinical Study IdentifierNCT03217006
SponsorWeill Medical College of Cornell University
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery

Exclusion Criteria

Age > 70 years
Single graft
Emergency operation
Evolving myocardial infarction within 48 hours of surgery
Left ventricular ejection fraction of < 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 reduce 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
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