Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; CADENCE Research Group, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.
Patients with recent coronary artery bypass graft (CABG) surgery are at risk for early graft failure, which is associated with a risk of myocardial infarction and death. In the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced the primary major adverse cardiovascular events (MACE) outcome of cardiovascular death, stroke, or myocardial infarction. Rivaroxaban 5 mg twice daily alone did not significantly reduce MACE.
This pre-planned substudy sought to determine whether the COMPASS treatments are more effective than aspirin alone for preventing graft failure and MACE after CABG surgery.
The substudy randomized 1,448 COMPASS trial patients 4 to 14 days after CABG surgery to receive the combination of rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. The primary outcome was graft failure, diagnosed by computed tomography angiogram 1 year after surgery.
The combination of rivaroxaban and aspirin and the regimen of rivaroxaban alone did not reduce the graft failure rates compared with aspirin alone (combination vs. aspirin: 113 [9.1%] vs. 91 [8.0%] failed grafts; odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45; rivaroxaban alone vs. aspirin: 92 [7.8%] vs. 92 [8.0%] failed grafts; OR: 0.95; 95% CI: 0.67 to 1.33; p = 0.75). Compared with aspirin, the combination was associated with fewer MACE (12 [2.4%] vs. 16 [3.5%]; hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone was not (16 [3.3%] vs. 16 [3.5%]; HR: 0.99, CI: 0.50 to 1.99; p = 0.98). There was no fatal bleeding or tamponade within 30 days of randomization.
The combination of rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone compared with aspirin alone did not reduce graft failure in patients with recent CABG surgery, but the combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in MACE, as observed in the larger COMPASS trial. (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS]; NCT01776424).
近期行冠状动脉旁路移植术（CABG）的患者存在早期移植物失败的风险，这与心肌梗死和死亡的风险相关。COMPASS（使用抗凝策略的人群心血管结局）试验中，与每日一次 100mg 阿司匹林相比，每日两次 2.5mg 利伐沙班加阿司匹林可降低心血管死亡、卒中和心肌梗死的主要不良心血管事件（MACE）主要终点。每日两次 5mg 利伐沙班单独治疗并未显著降低 MACE。
这项预先计划的亚组研究旨在确定 COMPASS 治疗方案是否比单独使用阿司匹林更能预防 CABG 手术后的移植物失败和 MACE。
该亚组研究将 COMPASS 试验的 1448 例患者随机分配至 CABG 手术后 4-14 天，接受利伐沙班加阿司匹林联合治疗、利伐沙班单药治疗或阿司匹林单药治疗。主要结局是术后 1 年通过计算机断层血管造影术诊断的移植物失败。
与阿司匹林单药治疗相比，利伐沙班加阿司匹林联合治疗和利伐沙班单药治疗并未降低移植物失败率（联合治疗组 vs. 阿司匹林组：113 [9.1%] 例 vs. 91 [8.0%] 例移植物失败；比值比[OR]：1.13；95%置信区间[CI]：0.82 至 1.57；p=0.45；利伐沙班单药治疗组 vs. 阿司匹林组：92 [7.8%] 例 vs. 92 [8.0%] 例移植物失败；OR：0.95；95%CI：0.67 至 1.33；p=0.75）。与阿司匹林相比，联合治疗组的 MACE 发生率较低（12 [2.4%] 例 vs. 16 [3.5%]；风险比[HR]：0.69；95%CI：0.33 至 1.47；p=0.34），而利伐沙班单药治疗组则没有（16 [3.3%] 例 vs. 16 [3.5%]；HR：0.99，CI：0.50 至 1.99；p=0.98）。随机分组后 30 天内无致命性出血或心包填塞。
与阿司匹林单药治疗相比，近期 CABG 术后患者使用每日两次 2.5mg 利伐沙班加阿司匹林或每日两次 5mg 利伐沙班单药治疗并未降低移植物失败率，但每日两次 2.5mg 利伐沙班加阿司匹林联合治疗与 COMPASS 试验中观察到的 MACE 发生率降低相似。（使用抗凝策略的人群心血管结局[COMPASS]；NCT01776424）。
