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药物洗脱支架与金属裸支架置入治疗 ST 段抬高型心肌梗死患者的长期预后:急性心肌梗死药物洗脱和远端保护(DEDICATION)随机试验的 3 年随访结果。

Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial.

机构信息

Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.

出版信息

J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.

Abstract

OBJECTIVES

The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).

BACKGROUND

The evidence of long-term efficacy and safety after implantation of DES in patients with complex lesions is scarce.

METHODS

We randomly assigned 626 patients with STEMI referred within 12 h to have a DES or a BMS implanted in the infarct-related lesion with or without distal protection during primary percutaneous coronary intervention.

RESULTS

At 3 years, target lesion revascularization was 6.1% in the DES group compared with 16.3% in the BMS group (p<0.001), and the rate of major adverse cardiac events was 11.5% versus 18.2%, respectively (p=0.02). Whereas all-cause mortality did not differ significantly, the rate of cardiac death was higher in the DES group, 6.1% versus 1.9% for the BMS group (p=0.01). The occurrence of reinfarction, stroke, and stent thrombosis was similar.

CONCLUSIONS

Implantation of DES in patients with STEMI reduces the long-term rate of major adverse cardiac events compared with BMS, but patients with DES had a higher risk of cardiac death not attributed to myocardial infarction or stent thrombosis. (Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction [DEDICATION]; NCT00192868)

摘要

目的

本研究旨在比较 ST 段抬高型心肌梗死(STEMI)患者接受药物洗脱支架(DES)和金属裸支架(BMS)植入后的长期临床结局。

背景

DES 植入后在复杂病变患者中具有长期疗效和安全性的证据有限。

方法

我们将 626 例 STEMI 患者随机分配,在发病 12 小时内行直接经皮冠状动脉介入治疗(PCI),于梗死相关病变处植入 DES 或 BMS,或同时应用远端保护装置。

结果

3 年时,DES 组的靶病变血运重建率为 6.1%,BMS 组为 16.3%(p<0.001),主要不良心脏事件发生率分别为 11.5%和 18.2%(p=0.02)。两组全因死亡率无显著差异,但 DES 组的心脏死亡率较高,为 6.1%,BMS 组为 1.9%(p=0.01)。再梗死、卒中和支架血栓形成的发生率相似。

结论

与 BMS 相比,DES 植入可降低 STEMI 患者的长期主要不良心脏事件发生率,但 DES 组的心脏死亡风险更高,且并非归因于心肌梗死或支架血栓形成。(ST 段抬高型心肌梗死经皮冠状动脉介入治疗中药物洗脱和远端保护[DEDICATION];NCT00192868)

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