Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial - rationale and study protocol

The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft(SAG) 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 these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicenter trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the center and the type of second arterial graft will be used.

The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization.The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery.

For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels.For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery.Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary and secondary outcomes, the sample size will be set at 4300 patients.The primary outcome will be tested according to the intention-to-treat principle.