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多中心随机试验:在生物可降解支架置入治疗长或多支冠状动脉疾病后,使用西洛他唑 3 个月,联合双联抗血小板治疗。

Multicenter randomized trial of 3-month cilostazol use in addition to dual antiplatelet therapy after biolimus-eluting stent implantation for long or multivessel coronary artery disease.

机构信息

Division of Cardiology, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea.

Division of Cardiology, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea.

出版信息

Am Heart J. 2014 Feb;167(2):241-248.e1. doi: 10.1016/j.ahj.2013.08.028. Epub 2013 Oct 22.

Abstract

BACKGROUND

There are conflicting data on the use of cilostazol as triple antiplatelet therapy (TAPT) for improving clinical outcomes after drug-eluting stent implantation. We aimed to evaluate whether 3-month use of cilostazol in addition to dual antiplatelet therapy (DAPT) improved clinical outcomes in patients with long or multivessel coronary artery disease (CAD) after biolimus-eluting stent (BES) implantation.

METHODS

Patients (n = 630) who had been successfully treated with BES implantation for lesions with ≥28 mm in stent length or ≥2 stents for different coronary arteries were enrolled in this prospective randomized multicenter trial. All patients were randomly assigned to receive either DAPT (aspirin and clopidogrel for 12 months, n = 314) or TAPT (DAPT plus 3-month cilostazol use, n = 316). The primary end point was a device-oriented composite consisting of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel), and ischemia-driven target lesion revascularization at 1-year follow-up.

RESULTS

A total of 314 patients in DAPT and 308 patients in TAPT were analyzed. Multivessel CAD was present in 65.7% of patients. Stents ≥28 mm in length were implanted in 58.1% of lesions. There were no significant differences in baseline and angiographic characteristics between the 2 groups. The primary end point was similar between the 2 groups (2.3% in DAPT vs 1.9% in TAPT, log-rank P = .799).

CONCLUSIONS

In patients treated with BES implantation for long or multivessel CAD, 3 months of cilostazol use in addition to DAPT did not improve clinical outcome at 1-year follow-up.

摘要

背景

在药物洗脱支架植入术后,使用西洛他唑作为三联抗血小板治疗(TAPT)以改善临床结局方面存在相互矛盾的数据。我们旨在评估在生物可降解支架(BES)植入后,对于长病变或多支血管病变的患者,在双联抗血小板治疗(DAPT)基础上加用西洛他唑 3 个月是否改善临床结局。

方法

本前瞻性随机多中心试验纳入了 630 例因病变长度≥28mm 的支架或不同冠状动脉≥2 个支架而成功接受 BES 植入的患者。所有患者均随机分配接受 DAPT(阿司匹林和氯吡格雷治疗 12 个月,n=314)或 TAPT(DAPT 加西洛他唑 3 个月治疗,n=316)。主要终点是 1 年随访时的器械导向的复合终点,包括心源性死亡、心肌梗死(不能明确归因于非靶病变血管)和缺血驱动的靶病变血运重建。

结果

在 DAPT 组的 314 例患者和 TAPT 组的 308 例患者中进行了分析。多支血管 CAD 占 65.7%的患者。58.1%的病变中植入了长度≥28mm 的支架。两组患者的基线和血管造影特征无显著差异。两组之间的主要终点无显著差异(DAPT 组为 2.3%,TAPT 组为 1.9%,对数秩检验 P=0.799)。

结论

在接受 BES 植入治疗长病变或多支血管 CAD 的患者中,DAPT 基础上加用西洛他唑 3 个月并不能改善 1 年随访时的临床结局。

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