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药物洗脱支架经皮冠状动脉介入治疗患者双联抗血小板治疗的最佳停药时机:随机试验的荟萃分析

The optimal discontinuation of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention with drug-eluting stents: A meta-analysis of randomized trials.

作者信息

Wang Wei, Liu Jing, Fang Jingxue, Liu Yang, An Tong, Zou Meijuan, Cheng Gang

机构信息

Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang, Liaoning, China.

Department of Cardiology, General Hospital of Shenyang Military Area, Shenhe District, Shenyang, Liaoning, China.

出版信息

Int J Cardiol. 2017 May 15;235:73-86. doi: 10.1016/j.ijcard.2017.02.091. Epub 2017 Feb 24.

DOI:10.1016/j.ijcard.2017.02.091
PMID:28284499
Abstract

BACKGROUND

Current guidelines recommend prolonged dual antiplatelet therapy (DAPT) for patients with drug-eluting stents (DES) implantation. Nevertheless, optimal discontinuation of DAPT remains a controversy. We performed a meta-analysis of all randomized controlled trials (RCTs) that evaluate optimal discontinuation of DAPT in patients undergoing percutaneous coronary intervention (PCI) with DES.

METHODS

We searched electronic databases including PubMed, Cochrane Library, EMBASE and ClinicalTrials.gov from database RCTs that reported different modes of discontinuation of DAPT in patients with DES. The primary endpoints were all-cause death, cardiovascular death, myocardial infarction (MI) and probably or definite stent thrombosis (ST). Secondary endpoints were repeat revascularization, stroke, major bleeding and net adverse clinical events (NACE).

RESULTS

We included 13 RCTs meeting the criteria with a total of 36,749 patients. No significant difference was observed in all-cause death (RR [95% CI]=0.87 [0.75, 1.01], P=0.07, I=0%), cardiovascular death (RR [95% CI]=0.97 [0.79, 1.19], P=0.76, I=0%), repeat revascularization (RR [95% CI]=1.07 [0.92, 1.25], P=0.36, I=0%), and stroke (RR [95% CI]=1.01 [0.80, 1.28], P=0.94, I=0%). Compared with shorter DAPT, longer DAPT was associated with a significant reduction in MI (RR [95% CI]=1.46 [1.26, 1.69], P<0.00001, I=28%) and ST (RR [95% CI]=1.93 [1.45, 2.58], P<0.00001, I=32%), and a significant increase in major bleeding (RR [95% CI]=0.60 [0.49, 0.74], P<0.00001, I=0%). However, there was no difference in NACE (RR [95% CI]=1.03 [0.91, 1.17], P=0.63, I=0%). In subgroup analyses based on stent type, we demonstrated that longer DAPT was associated with a significant reduction in thrombotic events (MI and ST) after first-generation DES implantation (RR [95% CI]=2.58 [1.85, 3.58], I=0%) and everolimus-eluting stents (EES, RR [95% CI]=1.54 [1.12, 2.11], I=0%). Conversely, there was no difference in thrombotic events in patients with zotarolimus-eluting stents (ZES, RR [95% CI]=1.17 [0.83, 1.63], I=75%) and biodegradable polymer DES (BP-DES, RR [95% CI]=1.15 [0.74, 1.79]).

CONCLUSIONS

  1. Compared with shorter DAPT, longer DAPT was associated with a significant reduction in thrombotic events (MI and ST) and a higher rate of major bleeding. 2) By the assessment of the trade-off between thrombotic and hemorrhagic events, shorter DAPT was non-inferior to longer DAPT. 3) The benefit of longer DAPT was significant in patients with first-generation DES and EES and weakened with other second-generation DES (ZES and BP-DES).
摘要

背景

当前指南推荐对药物洗脱支架(DES)植入患者进行延长的双联抗血小板治疗(DAPT)。然而,DAPT的最佳停药时间仍存在争议。我们对所有评估DES经皮冠状动脉介入治疗(PCI)患者DAPT最佳停药时间的随机对照试验(RCT)进行了荟萃分析。

方法

我们检索了电子数据库,包括PubMed、Cochrane图书馆、EMBASE和ClinicalTrials.gov,以获取报告DES患者不同DAPT停药模式的数据库RCT。主要终点为全因死亡、心血管死亡、心肌梗死(MI)以及可能或确定的支架血栓形成(ST)。次要终点为重复血运重建、中风、大出血和净不良临床事件(NACE)。

结果

我们纳入了13项符合标准的RCT,共36749例患者。在全因死亡(RR [95% CI]=0.87 [0.75, 1.01],P=0.07,I=0%)、心血管死亡(RR [95% CI]=0.97 [0.79, 1.19],P=0.76,I=0%)、重复血运重建(RR [95% CI]=1.07 [0.92, 1.25],P=0.36,I=0%)和中风(RR [95% CI]=1.01 [0.80, 1.28],P=0.94,I=0%)方面未观察到显著差异。与较短疗程的DAPT相比,较长疗程的DAPT与MI(RR [95% CI]=1.46 [1.26, 1.69],P<0.00001,I=28%)和ST(RR [95% CI]=1.93 [1.45, 2.58],P<0.00001,I=32%)显著减少以及大出血显著增加(RR [95% CI]=0.60 [0.49, 0.74],P<0.00001,I=0%)相关。然而,NACE方面无差异(RR [95% CI]=1.03 [0.91, 1.17],P=0.63,I=0%)。在基于支架类型的亚组分析中,我们表明较长疗程的DAPT与第一代DES植入后血栓事件(MI和ST)显著减少相关(RR [95% CI]=2.58 [1.85, 3.58],I=0%)以及依维莫司洗脱支架(EES,RR [95% CI]=1.54 [1.12, 2.11],I=0%)。相反,佐他莫司洗脱支架(ZES,RR [95% CI]=1.17 [0.83, 1.63],I=75%)和生物可降解聚合物DES(BP-DES,RR [95% CI]=1.15 [0.74, 1.79])患者的血栓事件无差异。

结论

1)与较短疗程的DAPT相比,较长疗程的DAPT与血栓事件(MI和ST)显著减少以及大出血发生率较高相关。2)通过评估血栓和出血事件之间的权衡,较短疗程的DAPT不劣于较长疗程的DAPT。3)较长疗程的DAPT对第一代DES和EES患者的益处显著,而对其他第二代DES(ZES和BP-DES)则减弱。

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