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聚合物支架治疗高出血风险患者的疗效并不优于无聚合物支架

本期文章:《新英格兰医学杂志》:Online/在线发表

聚合物支架或无聚合物支架PCI对高出血风险患者的疗效,这一成果由瑞士伯尔尼大学医院Stephan Windecker课题组经过不懈努力而取得。2020年2月12日,《新英格兰医学杂志》发表了这一最新研究成果。

在接受经皮冠状动脉介入治疗(PCI)并接受1个月双重抗血小板治疗的高出血风险的患者中,无聚合物药物涂层支架比裸金属支架具有更好的临床效果。然而,与无聚合物药物涂层支架相比,在此类患者中使用聚合物药物涂层支架的数据很有限。

在一项国际、随机、单盲试验中,研究组招募了1996例高出血风险患者,这些患者经PCI后,均接受1个月的双重抗血小板治疗,之后再进行单次抗血小板治疗。将其按1:1随机分组,其中1003例接受聚合物磷酸基佐他莫司洗脱支架,993例接受不含聚合物的尿嘧啶涂层支架。

1年后,佐他莫司洗脱支架组中有17.1%的患者发生心脏原因死亡、心肌梗死或支架血栓形成,无聚合物药物涂层支架组中有16.9%,符合非劣效性标准。佐他莫司洗脱支架组中有17.6%的患者发生靶病变衰竭,无聚合物药物涂层支架组中有17.4%。

总之,对于PCI术后接受1个月双重抗血小板治疗的高出血风险患者,使用聚合物磷酸基佐他莫司洗脱支架的安全性和有效性均不优于使用无聚合物药物涂层支架。

附:英文原文

Title: Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk

Author: Stephan Windecker, M.D.,, Azeem Latib, M.D.,, Elvin Kedhi, M.D., Ph.D.,, Ajay J. Kirtane, M.D.,, David E. Kandzari, M.D.,, Roxana Mehran, M.D.,, Matthew J. Price, M.D.,, Alexandre Abizaid, M.D.,, Daniel I. Simon, M.D.,, Stephen G. Worthley, M.B., B.S., Ph.D.,, Azfar Zaman, M.D.,, Martin Hudec, M.D.,, Petra Poliacikova, M.D.,, A. Kahar bin Abdul Ghapar, M.D.,, Kamaraj Selvaraj, M.D.,, Ivo Petrov, M.D., Ph.D.,, Darren Mylotte, M.D.,, Eduardo Pinar, M.D.,, Raul Moreno, M.D.,, Franco Fabbiocchi, M.D.,, Sanjeevan Pasupati, M.D.,, Hyo-Soo Kim, M.D., Ph.D.,, Adel Aminian, M.D.,, Charles Tie, M.D.,, Adrian Wlodarczak, M.D.,, Seung-Ho Hur, M.D., Ph.D.,, Steven O. Marx, M.D.,, Ivana Jankovic, M.D.,, Sandeep Brar, M.D.,, Lisa Bousquette, M.S.,, Minglei Liu, Ph.D.,, and Gregg W. Stone, M.D.

Issue&Volume: 2020-02-12

Abstract:

Background

Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.

Methods

In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus–coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.

Results

A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P=0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P=0.007 for noninferiority).

Conclusions

Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)

DOI: 10.1056/NEJMoa1910021

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1910021

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
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