ROMA Summary

Explaining ROMA

In the 1980’s, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the LAD was grafted with a left ITA rather than a saphenous vein. 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).

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 Arterial Graft, especially over the long term. The current United States and European Guidelines encourage the use of Arterial Grafts in patients with a long life expectancy. Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of Arterial Grafts.

The putative mechanism underlying the Arterial Graft 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 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 Arterial Graft hypothesis.

However, recently the Arterial Graft hypothesis has been challenged due to the neutral results of the ART Trial and to a critical evaluation of the observational evidence suggesting that confounders and treatment allocation bias, and not biological superiority, may be the explanation for the better outcome associated with the use of Multiple Arterial Graft.

ROMA is a two-arm event-driven randomized multi-center 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, and 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.