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在常规临床实践中无限制使用依维莫司洗脱和西罗莫司洗脱支架的结果:一项多中心、前瞻性队列研究。

Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study.

机构信息

Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

出版信息

Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.

DOI:10.1161/CIRCINTERVENTIONS.111.966549
PMID:22693347
Abstract

BACKGROUND

It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice.

METHODS AND RESULTS

We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75).

CONCLUSIONS

In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.

摘要

背景

目前尚不清楚在当代实践中,依维莫司洗脱支架(EES)和西罗莫司洗脱支架(SES)的安全性和疗效结果是否存在差异。

方法和结果

我们前瞻性纳入了 2008 年 4 月至 2010 年 6 月期间接受 EES(3081 例患者)和 SES(3085 例患者)治疗的 6166 例连续患者,数据来自介入心脏病学研究合作协会-药物洗脱支架注册处。主要终点是死亡、非致死性心肌梗死(MI)或靶血管血运重建(TVR)的复合终点。在 2 年的随访中,两组患者的主要终点的粗风险无显著差异(EES 组为 12.1%,SES 组为 12.4%;HR,0.97;95%CI,0.84-1.12,P=0.66)。在调整了基线风险因素后,两种支架类型的主要终点调整风险仍然相似(HR,0.96;95%CI,0.82-1.12,P=0.60)。支架组之间的死亡(HR,0.93;95%CI,0.67-1.30,P=0.68)、MI(HR,0.97;95%CI,0.79-1.18,P=0.74)和 TVR(HR,1.10;95%CI,0.82-1.49,P=0.51)的个体组成部分的调整风险也无差异。支架血栓形成的调整风险也相似(HR,1.16;95%CI,0.47-2.84,P=0.75)。

结论

在经皮冠状动脉介入治疗的当代实践中,无限制使用 EES 和 SES 的安全性和疗效结果相似,包括死亡、MI、支架血栓形成和 TVR。需要进行更长期的随访,以更好地确定这些药物洗脱支架的相对益处。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01070420。

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