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在随机TWENTE试验中,使用佐他莫司洗脱Resolute支架和依维莫司洗脱Xience V支架治疗的复杂患者:2年临床结果比较

Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome.

作者信息

Sen Hanim, Lam Ming Kai, Tandjung Kenneth, Löwik Marije M, Stoel Martin G, de Man Frits H A F, Louwerenburg J Hans W, van Houwelingen Gert K, Linssen Gerard C M, Doggen Carine J M, Basalus Mounir W Z, von Birgelen Clemens

机构信息

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.

出版信息

Catheter Cardiovasc Interv. 2015 Jan 1;85(1):74-81. doi: 10.1002/ccd.25464. Epub 2014 Mar 14.

DOI:10.1002/ccd.25464
PMID:24585502
Abstract

OBJECTIVE

To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).

BACKGROUND

Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).

METHODS

We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30%; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.

RESULTS

Among the 1,033 complex patients, 529 (51%) were treated with Resolute ZES and 504 (49%) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1% of patients treated with Resolute ZES and 12.3% of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization-the individual components of TVF.

CONCLUSION

Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up. © 2014 Wiley Periodicals, Inc.

摘要

目的

评估使用雷帕霉素洗脱支架(ZES)与依维莫司洗脱支架(EES)治疗的复杂患者临床结局的差异。

背景

如今,许多患有冠状动脉疾病的复杂患者接受经皮冠状动脉介入治疗,使用药物洗脱支架(DES)。

方法

我们分析了TWENTE试验中1033例复杂患者的2年结局数据,这些患者接受了第二代雷帕霉素洗脱支架或依维莫司洗脱支架治疗。复杂患者具有以下至少一项特征:肾功能不全(肌酐≥140 μmol/l);射血分数<30%;既往72小时内发生急性心肌梗死(MI);>1处病变/血管;>2处血管接受治疗;病变长度>27 mm;分叉病变;大隐静脉移植血管病变;动脉搭桥移植血管病变;支架内再狭窄;无保护左主干病变;有血栓的病变;或完全闭塞的病变。靶血管失败(TVF)是该试验的主要复合终点,定义为心源性死亡、靶血管相关心肌梗死或靶血管血运重建。

结果

在1033例复杂患者中,529例(51%)接受了雷帕霉素洗脱支架治疗,504例(49%)接受了依维莫司洗脱支架治疗。两组药物洗脱支架患者的患者和手术相关特征相似。经过2年随访,两组药物洗脱支架的结局也相似。接受雷帕霉素洗脱支架治疗的患者中12.1%发生靶血管失败,接受依维莫司洗脱支架治疗的患者中12.3%发生靶血管失败。此外,两组药物洗脱支架在心源性死亡、心肌梗死或靶血管血运重建(靶血管失败的各个组成部分)方面无显著差异。

结论

在2年随访期间,使用雷帕霉素洗脱支架和依维莫司洗脱支架治疗的复杂患者显示出相似的安全性和有效性。©2014威利期刊公司

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