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在冠状动脉旁路手术后使用氯吡格雷的益处和风险:随机试验和观察性研究的系统评价和荟萃分析。

Benefits and risks of using clopidogrel before coronary artery bypass surgery: systematic review and meta-analysis of randomized trials and observational studies.

机构信息

Division of Cardiothoracic and Vascular Surgery, Department of Surgery, Oulu University Hospital, Oulu, Finland.

出版信息

J Thorac Cardiovasc Surg. 2012 Mar;143(3):665-675.e4. doi: 10.1016/j.jtcvs.2011.01.069. Epub 2011 Jun 24.

DOI:10.1016/j.jtcvs.2011.01.069
PMID:21703636
Abstract

OBJECTIVE

The benefits and risks associated with the use of clopidogrel before coronary artery bypass grafting are controversial, and these were investigated in the present meta-analysis.

METHODS

A systematic literature search was performed to identify studies on the use of clopidogrel before coronary artery bypass grafting. Meta-analysis was performed according to the Cochrane Handbook for Systematic Reviews.

RESULTS

The literature search yielded 3 prospective randomized studies and 17 observational studies with valid data. Randomized studies were post hoc analyses of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY), Clopidogrel for the Reduction of Events During Observation (CREDO), and Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events trials. Meta-analysis based on these data showed a nonsignificant reduced risk of immediate postoperative composite end point (death, myocardial infarction, or stroke) in the clopidogrel group (risk ratio [RR], 0.77; 95% confidence interval [CI], 0.58-1.04). Data from the CREDO and CLARITY trials showed a similar risk of death (RR, 0.81; 95% CI, 0.20-3.37), myocardial infarction (RR, 0.58; 95% CI, 0.25-1.33), and major bleeding according to Thrombolysis in Myocardial Infarction criteria (RR, 1.48; 95% CI, 0.72-3.04). Meta-analysis of observational studies showed that preoperative exposure to clopidogrel was associated with an increased risk of death (RR, 1.30; 95% CI, 1.02-1.67), reoperation for bleeding (RR, 1.88; 95% CI, 1.37-2.58), blood loss (mean difference, 157.8 mL; 95% CI, 61.9-253.6), need of packed red blood cell transfusion (RR, 1.23; 95% CI, 1.10-1.37), and increased use of blood products. A significantly reduced risk of postoperative myocardial infarction was observed among patients taking clopidogrel (RR, 0.63; 95% CI, 0.48-0.82).

CONCLUSIONS

Contrary to the findings of post hoc analyses of randomized trials, observational studies showed that recent exposure to clopidogrel before coronary artery bypass grafting is associated with increased risk of postoperative death, reoperations for bleeding, blood loss, and need of blood transfusions.

摘要

目的

在冠状动脉旁路移植术前使用氯吡格雷的获益和风险存在争议,本研究对此进行了荟萃分析。

方法

系统检索了关于冠状动脉旁路移植术前使用氯吡格雷的研究。根据 Cochrane 系统评价手册进行荟萃分析。

结果

文献检索得到 3 项前瞻性随机研究和 17 项具有有效数据的观察性研究。随机研究是 Clopidogrel as Adjunctive Reperfusion Therapy(CLARITY)、Clopidogrel for the Reduction of Events During Observation(CREDO)和 Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events 试验的事后分析。基于这些数据的荟萃分析显示,氯吡格雷组术后复合终点(死亡、心肌梗死或卒中)的风险降低,但无统计学意义(风险比 [RR],0.77;95%置信区间 [CI],0.58-1.04)。来自 CREDO 和 CLARITY 试验的数据显示,根据血栓溶解治疗心肌梗死标准,死亡(RR,0.81;95% CI,0.20-3.37)、心肌梗死(RR,0.58;95% CI,0.25-1.33)和大出血的风险相似(RR,1.48;95% CI,0.72-3.04)。观察性研究的荟萃分析显示,术前暴露于氯吡格雷与死亡风险增加相关(RR,1.30;95% CI,1.02-1.67)、再次出血(RR,1.88;95% CI,1.37-2.58)、出血量(平均差值,157.8 mL;95% CI,61.9-253.6)、需要输红细胞(RR,1.23;95% CI,1.10-1.37)和血液制品使用增加有关。接受氯吡格雷治疗的患者术后心肌梗死风险显著降低(RR,0.63;95% CI,0.48-0.82)。

结论

与随机试验事后分析的结果相反,观察性研究显示,冠状动脉旁路移植术前近期使用氯吡格雷与术后死亡、再次出血手术、失血和输血需求增加相关。

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