Department of Cardiology (L.M.W., P.W.A.J., J.P., D.R.P.P.C.P.Y., M.E.G., K.F.B., J.C.K., B.J.W.M.R., M.J.S., J.M.t.B.), St Antonius Hospital, Nieuwegein, The Netherlands.
Department of Radiology (J.P.), University Medical Center Utrecht, Utrecht, The Netherlands.
Circulation. 2020 Nov 10;142(19):1799-1807. doi: 10.1161/CIRCULATIONAHA.120.050749. Epub 2020 Aug 31.
Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG.
In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death.
Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; =0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]).
In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.
尽管在冠状动脉旁路移植术后(CABG)使用阿司匹林,但约有 15%的隐静脉移植物(SVGs)在术后第一年发生闭塞。POPular CABG 试验(替格瑞洛对冠状动脉旁路移植术后患者隐静脉桥通畅率的影响)研究了替格瑞洛加用标准阿司匹林是否能改善 CABG 后 1 年的 SVG 通畅率。
在这项由研究者发起的、随机、双盲、安慰剂对照、多中心试验中,在 CABG 后,将 ≥1 支 SVG 的患者按 1:1 随机分配(替格瑞洛或安慰剂)加用标准阿司匹林(80 mg 或 100 mg)。所有具有主要结局影像学的患者均采用冠状动脉计算机断层扫描血管造影评估 1 年时的 SVG 闭塞情况,这是主要结局。采用广义估计方程模型对每支 SVG 进行主要分析。次要结局是 1 年 SVG 失败,这是 SVG 闭塞、SVG 血运重建、由 SVG 供应的心肌区域心肌梗死或猝死的复合结局。
在 499 例随机分配的患者中,平均年龄为 67.9±8.3 岁,87.1%为男性,CABG 的适应证为急性冠状动脉综合征占 31.3%,95.2%的手术采用体外循环。替格瑞洛组有 220 例患者和安慰剂组有 223 例患者可进行主要结局影像学检查。替格瑞洛组的 SVG 闭塞率为 10.5%(484 支 SVG 中有 51 支),安慰剂组为 9.1%(470 支 SVG 中有 43 支),比值比为 1.29 [95%CI,0.73-2.30];P=0.38。替格瑞洛组有 35 例(14.2%)患者发生 SVG 失败,安慰剂组有 29 例(11.6%)患者发生 SVG 失败(比值比,1.22 [95%CI,0.72-2.05])。
在这项随机、安慰剂对照试验中,替格瑞洛加用标准阿司匹林并未降低 CABG 后 1 年的 SVG 闭塞率。