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Randomization of Single vs Multiple Arterial Grafts (ROMA) in Female Patients

2019-10-17 11:03:43 | BioPortfolio

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.

By leveraging the existing infrastructure of the on-going Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts (ROMA) trial, this proposal is aimed at examining the effect of multiple arterial revascularization during CABG in women.

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.

Study Design

Conditions

Heart Diseases

Intervention

Procedure: Single arterial graft, Procedure: Multiple arterial grafting

Status

Not yet recruiting

Source

Maastricht University Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:43-0400

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Medical and Biotech [MESH] Definitions

Procedure in which arterial blood pressure is intentionally reduced in order to control blood loss during surgery. This procedure is performed either pharmacologically or by pre-surgical removal of blood.

Surgical procedure for anatomical correction of transposed great arteries (e.g., DOUBLE OUTLET RIGHT VENTRICLE).

Thickening and loss of elasticity of the walls of medium and large muscular ARTERIES with lesions in the innermost layer of the artery (ARTERIAL INTIMA). This disease process of atherogenesis includes the retention of cholesterol-rich LIPOPROTEINS and their binding to PROTEOGLYCANS in the arterial intima, generation of proinflammatory molecules that recruit MACROPHAGES to the subendothelial space, formation of FOAM CELLS, and eventual calcification of the arterial wall. These arterial plaques (atheromas) contain CARBOHYDRATES; BLOOD; and CALCIUM.

Blocking of a blood vessel by CHOLESTEROL-rich atheromatous deposits, generally occurring in the flow from a large artery to small arterial branches. It is also called arterial-arterial embolization or atheroembolism which may be spontaneous or iatrogenic. Patients with spontaneous atheroembolism often have painful, cyanotic digits of acute onset.

Pathological processes which result in the partial or complete obstruction of ARTERIES. They are characterized by greatly reduced or absence of blood flow through these vessels. They are also known as arterial insufficiency.

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