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随机试验阿司匹林和氯吡格雷与阿司匹林单独预防冠状动脉旁路移植术闭塞:术前阿司匹林和术后抗血小板在冠状动脉旁路移植术中的研究。

Randomized trial of aspirin and clopidogrel versus aspirin alone for the prevention of coronary artery bypass graft occlusion: the Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting study.

机构信息

Division of Cardiac Surgery, McMaster University, Hamilton, Canada.

出版信息

Am Heart J. 2010 Dec;160(6):1178-84. doi: 10.1016/j.ahj.2010.07.035.

DOI:10.1016/j.ahj.2010.07.035
PMID:21146675
Abstract

BACKGROUND

Routine use of postoperative aspirin after coronary artery bypass grafting (CABG) reduces graft failure and cardiovascular events. The efficacy and safety of adding clopidogrel to aspirin for the prevention of graft failure and cardiovascular events after CABG are unknown. We performed a pilot study measuring safety and efficacy outcomes of aspirin and clopidogrel therapy after CABG.

METHODS

We randomized 100 patients undergoing CABG to receive placebo or clopidogrel started after surgery and for 30 days. All patients received aspirin 81 mg daily. Graft patency was measured by cardiac computed tomography angiography at 30 days.

RESULTS

Clinical follow-up was complete for 99 patients, and 79 (80%) underwent computed tomography angiography. The proportion of patients with ≥1 occluded graft was not significantly different between placebo and clopidogrel groups (9/39 [23.1%] vs 7/40 [17.5%], relative risk 0.95, 95% CI 0.80-1.14, P=.54). Among radial artery grafts, the placebo group had a significantly higher number of occlusions or "string signs" compared with the clopidogrel group (7/16 [43.8%] vs 2/19 [10.5%], relative risk 0.24, 95% CI 0.06-1.00, P=.05). There was no difference between placebo and clopidogrel groups in the safety outcomes of total postoperative bleeding, transfusions, bleeding events, and reexploration and in the efficacy outcomes of nonfatal myocardial infarction, stroke, and death.

CONCLUSIONS

This pilot study confirms a high rate of graft occlusion after CABG surgery and suggests that the addition of clopidogrel to aspirin is feasible and safe and may be superior for prevention of graft failure in radial artery grafts.

摘要

背景

在冠状动脉旁路移植术(CABG)后常规使用阿司匹林可降低移植物失败和心血管事件的风险。在 CABG 后,加用氯吡格雷预防移植物失败和心血管事件的疗效和安全性尚不清楚。我们进行了一项初步研究,以评估 CABG 后阿司匹林和氯吡格雷治疗的安全性和疗效。

方法

我们将 100 例接受 CABG 的患者随机分为安慰剂组或术后开始并持续 30 天的氯吡格雷组。所有患者均每日服用 81mg 阿司匹林。术后 30 天通过心脏计算机断层血管造影术测量移植物通畅情况。

结果

99 例患者的临床随访完整,79 例(80%)接受了计算机断层血管造影术。安慰剂组和氯吡格雷组之间闭塞的移植物比例无显著差异(9/39 [23.1%] vs 7/40 [17.5%],相对风险 0.95,95%可信区间 0.80-1.14,P=.54)。在桡动脉移植物中,安慰剂组的闭塞或“条索征”数量明显高于氯吡格雷组(7/16 [43.8%] vs 2/19 [10.5%],相对风险 0.24,95%可信区间 0.06-1.00,P=.05)。安慰剂组和氯吡格雷组在术后总出血、输血、出血事件、再次探查以及非致命性心肌梗死、卒中和死亡的疗效结果方面无差异。

结论

本初步研究证实 CABG 术后移植物闭塞率较高,并表明阿司匹林加氯吡格雷是可行且安全的,并且可能更有利于预防桡动脉移植物的失败。

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