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急性心肌梗死患者中可生物降解聚合物涂层薄支架西罗莫司洗脱支架与耐用聚合物涂层依维莫司洗脱支架的安全性和有效性比较

Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction.

作者信息

Gąsior Paweł, Gierlotka Marek, Szczurek-Katanski Krzysztof, Osuch Marcin, Roleder Magda, Hawranek Michal, Gasior Mariusz, Wojakowski Wojciech, Polonski Lech

机构信息

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.

3 Department of Cardiology, Silesian Centre for Heart Diseases, Zabrze, Poland.

出版信息

Postepy Kardiol Interwencyjnej. 2018;14(4):347-355. doi: 10.5114/aic.2018.79194. Epub 2018 Nov 9.

Abstract

INTRODUCTION

The biodegradable polymer drug-eluting stents were developed to improve vascular healing. However, further data are needed to confirm the safety and efficacy of these stents in patients with acute myocardial infarction (AMI).

AIM

We sought to determine the 1-year clinical follow-up in patients with AMI treated with a thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus a durable coating everolimus-eluting stent (DP-EES).

MATERIAL AND METHODS

We analyzed patients with AMI (STEMI and NSTEMI) treated with either a BP-SES (ALEX, Balton, Poland, = 886) or DP-EES (XIENCE, Abbott, USA, = 1054) with available 1-year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as the efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.

RESULTS

After propensity score matching 672 patients treated with BP-SES and 672 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between the groups. In-hospital mortality was similar in both tested groups. One-year follow-up demonstrated comparable efficacy outcome TVR (BP-SES 7.1% vs. DP-EES 5.2%, = 0.14), as well as similar safety outcomes of all-cause death, myocardial infarction, and definite/probable stent thrombosis.

CONCLUSIONS

The thin-strut biodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1 year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in AMI patients undergoing percutaneous coronary intervention.

摘要

引言

可生物降解聚合物药物洗脱支架的研发旨在改善血管愈合。然而,尚需更多数据来证实这些支架在急性心肌梗死(AMI)患者中的安全性和有效性。

目的

我们试图确定急性心肌梗死患者接受薄支柱可生物降解聚合物涂层西罗莫司洗脱支架(BP-SES)与耐用涂层依维莫司洗脱支架(DP-EES)治疗后的1年临床随访情况。

材料与方法

我们分析了接受BP-SES(ALEX,Balton,波兰,n = 886)或DP-EES(XIENCE,雅培,美国,n = 1054)治疗且有1年临床随访数据的急性心肌梗死(STEMI和NSTEMI)患者,采用倾向评分匹配法。结局指标包括作为疗效指标的靶血管血运重建(TVR)以及作为安全性指标的全因死亡、心肌梗死和明确/可能的支架血栓形成。

结果

经过倾向评分匹配,选择了672例接受BP-SES治疗的患者和672例接受DP-EES治疗的患者。两组间的手术和临床特征相似。两个试验组的院内死亡率相似。1年随访显示,疗效指标TVR相当(BP-SES为7.1%,DP-EES为5.2%,P = 0.14),全因死亡、心肌梗死和明确/可能的支架血栓形成等安全性指标也相似。

结论

薄支柱可生物降解聚合物涂层西罗莫司洗脱支架在植入后1年的临床结局与DP-EES相当。这些数据支持BP-SES在接受经皮冠状动脉介入治疗的AMI患者中的相对安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b39e/6309843/3290359007cc/PWKI-14-34029-g001.jpg

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