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与裸金属支架相比,第二代药物洗脱支架的极晚期支架内血栓形成:随机原发性经皮冠状动脉介入试验的网状荟萃分析

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

作者信息

Philip Femi, Stewart Susan, Southard Jeffrey A

机构信息

Department of Internal Medicine and Biostatistics, University of California, Davis, California.

出版信息

Catheter Cardiovasc Interv. 2016 Jul;88(1):38-48. doi: 10.1002/ccd.26458. Epub 2016 Feb 24.

Abstract

BACKGROUND

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared.

METHODS

Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials.

RESULTS

Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years.

CONCLUSIONS

Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc.

摘要

背景

药物洗脱支架(DES)与裸金属支架(BMS)在ST段抬高型心肌梗死(STEMI)的直接经皮冠状动脉介入治疗(PPCI)中的相对安全性仍存在争议。本研究采用网状Meta分析比较了第二代DES与BMS用于直接经皮冠状动脉介入治疗(PCI)的长期临床结局。

方法

纳入比较支架类型(第一代DES、第二代DES或BMS)的随机对照试验。检索策略包括使用Medline、Embase、Cochrane数据库以及国际会议论文集。提取有关研究设计、纳入标准和样本特征的信息。采用网状Meta分析汇总随机试验中的直接证据(第二代DES与BMS的比较)和间接证据(第一代DES与BMS以及第二代DES之间的比较)。

结果

分析了12项比较所有支架类型的试验,共9673例患者被随机分配至治疗组。与BMS相比,第二代DES在3年时明确或可能的支架血栓形成(ST)发生率(OR 0.59,95%CI 0.39 - 0.89)、心肌梗死(MI)发生率(OR 0.59,95%CI 0.39 - 0.89)以及靶血管重建(TVR)发生率(OR 0.50:95%CI 0.31 - 0.81)均显著降低。此外,第二代DES在3年时的主要不良心血管事件(MACE)发生率也显著低于BMS(OR 0.54,95%CI 0.34 - 0.74)。这是由于BMS组在3年时较高的TVR、MI和支架血栓形成率所致。使用第二代DES与BMS相比,3年时总体死亡率和心脏死亡率无显著降低[OR 0.83,95%CI(0.60 - 1.14),OR 0.88,95%CI(0.6 - 1.28)]。

结论

对直接PCI随机试验的网状Meta分析表明,与BMS相比,第二代DES的MACE、MI、TVR和支架血栓形成发生率更低。©2016威利期刊公司。

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