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超薄支柱可生物降解聚合物涂层依维莫司洗脱支架在冠心病患者中的临床结局

Clinical outcomes of ultrathin strut biodegradable polymer-coated everolimus-eluting stent in patients with coronary artery disease.

作者信息

Patted Suresh V, Thakkar Ashok S

机构信息

Professor, Department of Cardiology, KLE Academy of Higher Education & Research, Belagavi, Karnataka, India.

Head, Department of Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India.

出版信息

ARYA Atheroscler. 2020 May;16(3):130-135. doi: 10.22122/arya.v16i3.1827.

Abstract

BACKGROUND

Evermine 50™ (Meril Life Sciences Pvt. Ltd., India) everolimus-eluting stent system (EES) is a novel ultrathin strut (50 µm) cobalt-chromium coronary drug-eluting stent (DES) platform with biodegradable polymer coating. The Evermine 50 EES-KLES study aimed to evaluate the Evermine 50 EES in terms of 24-month clinical safety and performance in patients with coronary artery disease (CAD).

METHODS

This retrospective study consisted of 171 patients (258 lesions) implanted with Evermine 50 EES for managing CAD. We analyzed the major adverse cardiac events (MACE) incidence, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (ID-TLR) at 6-, 12-, and 24-month follow-up.

RESULTS

A total of 171 patients were included with a mean age of 57.85 ± 10.05 years, of which, 139 (81.29%) were men, 69 (40.35%) were hypertensive, and 70 (40.94%) were diabetic. The incidence of MACE was 1 (0.58%), 3 (1.81%), and 4 (2.42%) at 6-, 12-, and 24-month follow-up, respectively. There were three cases (1.82%) of cardiac death and one case (0.61%) of ID-TLR up to 24 months. None of the patients was presented with definite or probable stent thrombosis (ST).

CONCLUSION

This study demonstrated that implantation of ultrathin strut Evermine 50 EES resulted in a low rate of incidence of MACE, indicating a favourable clinical safety and performance profile of Evermine 50 EES in patients with CAD [Clinical Trials Registry-India (CTRI) Number: CTRI/2017/09/009939)].

摘要

背景

Evermine 50™(印度 Meril Life Sciences Pvt. Ltd.公司)依维莫司洗脱支架系统(EES)是一种新型的超薄(50微米)钴铬合金冠状动脉药物洗脱支架(DES)平台,具有可生物降解聚合物涂层。Evermine 50 EES-KLES研究旨在评估Evermine 50 EES在冠心病(CAD)患者中的24个月临床安全性和性能。

方法

这项回顾性研究纳入了171例植入Evermine 50 EES以治疗CAD的患者(258个病变)。我们分析了在6个月、12个月和24个月随访时主要不良心脏事件(MACE)的发生率,MACE定义为心源性死亡、心肌梗死和缺血驱动的靶病变血运重建(ID-TLR)的复合事件。

结果

共纳入171例患者,平均年龄57.85±10.05岁,其中139例(81.29%)为男性,69例(40.35%)患有高血压,70例(40.94%)患有糖尿病。在6个月、12个月和24个月随访时,MACE的发生率分别为1例(0.58%)、3例(1.81%)和4例(2.42%)。至24个月时,有3例(1.82%)心源性死亡和1例(0.61%)ID-TLR。没有患者出现明确或可能的支架血栓形成(ST)。

结论

本研究表明,植入超薄支架的Evermine 50 EES导致MACE发生率较低,表明Evermine 50 EES在CAD患者中具有良好的临床安全性和性能[印度临床试验注册中心(CTRI)编号:CTRI/2017/09/009939]。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e37c/7778515/4bf8154b111c/ARYA-16-130f1.jpg

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