Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
Duke Clinical Research Institute, Duke Health, Durham, NC, USA.
Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1031-1040. doi: 10.1093/ejcts/ezx358.
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 multicentre 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 centre 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 outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored.
ROMA 试验的主要假设是，在接受初次择期非紧急冠状动脉旁路移植术的患者中，与使用单个动脉移植物（SAG）相比，使用 2 个或更多动脉移植物与复合结局（任何原因导致的死亡、任何卒中、出院后心肌梗死和/或再次血运重建）的降低相关。
次要假设是，与 SAG 相比，这些患者使用 2 个或更多动脉移植物与生存率的提高相关。ROMA 试验是一项前瞻性、非盲、随机事件驱动的多中心试验，至少包括 4300 例患者。年龄小于 70 岁、有左主干和/或多支血管疾病的患者将按 1:1 的比例随机分配至 SAG 或左冠状动脉系统的多个动脉移植物。将使用按中心和第二种动脉移植物类型分层的置换区组随机化。主要结局将是任何原因导致的死亡、任何卒中、出院后心肌梗死和/或再次血运重建的复合结局。次要结局将是全因死亡率。主要安全性结局将是任何原因导致的死亡、任何卒中和任何心肌梗死的复合结局。在所有患者中，将用 1 根内乳动脉吻合至前降支冠状动脉。对于随机分配至 SAG 组的患者，将使用隐静脉移植物治疗所有非前降支靶血管。对于随机分配至多个动脉移植物组的患者，将用桡动脉或第二根内乳动脉吻合侧壁的主要靶血管。对于多个动脉移植物组，其他移植物可以是隐静脉或补充性动脉移植物。为了检测主要结局有 20%的相对减少，在 5%的 alpha 和假设时间事件分析下，90%的功效，样本量必须包括 845 例事件（和 3650 例患者）。为了检测次要结局有 20%的相对减少，在 5%的 alpha 和 80%的功效下，样本量必须包括 631 例事件（和 3650 例患者）。为了保守起见，样本量将设定为 4300 例患者。将根据意向治疗原则检验主要结局。主要分析将是 Cox 比例风险回归模型，将治疗臂作为协变量。如果观察到非比例风险，则将探索 Cox 比例风险回归的替代方法。
