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依维莫司洗脱冠状动脉支架系统(Evermine50)在原发性冠状动脉病变患者中的安全性和有效性:单中心三年随访结果

Safety and efficacy of Evermine50 Everolimus-eluting coronary stent system in patients with native coronary artery lesions: Three-year outcomes from a single-center.

作者信息

Patted Suresh V

机构信息

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

出版信息

J Cardiovasc Thorac Res. 2025 Mar 18;17(1):58-65. doi: 10.34172/jcvtr.025.33123. eCollection 2025 Mar.

Abstract

INTRODUCTION

The Evermine50 (Meril Life Sciences Pvt. Ltd., India) is the world's thinnest strut (50 µm) featuring a biodegradable polymer-based Everolimus-eluting stent (EES) system. We present the 3-year safety and performance outcomes of Evermine50 EES.

METHODS

This was a prospective, post-marketing, single-center study of patients with native coronary artery lesions (CAL) in real-world settings. Patients with symptomatic ischemic heart disease due to and in-stent restenotic lesions (lengths<44mm) in native coronary arteries with reference vessel diameters of 2.0 - 4.5 mm. and eligible for stenting procedure with percutaneous transluminal coronary angioplasty were included.

RESULTS

A total of 251 patients (mean age: 58.20 years) were enrolled, of which 48.2% had ST-elevation myocardial infarction and 31.5% had silent ischemia. The mean lesion length was 21.81±8.14 mm, and 70.3% of patients had pre-procedure Thrombolysis in Myocardial Infarction (TIMI) flow grade III. The average and stent length was recorded as 23.50±12.21 mm. In 98% of patients, post-procedural TIMI-III flow grade was achieved. The cumulative rate of major adverse cardiac events defined as composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR) at 1, 2, and 3 years were 1.59%, 3.58%, and 3.58%, respectively. The cumulative rates of CD-TLR remained constant at 0.79% from 1 to 3 years. There were no cases of stent thrombosis until 3 years.

CONCLUSION

This study demonstrated favorable safety and performance of the ultrathin Evermine50 EES at 36 months in patients with native CAL.

摘要

引言

Evermine50(印度Meril生命科学私人有限公司)是世界上最薄的支架(50微米),具有基于可生物降解聚合物的依维莫司洗脱支架(EES)系统。我们展示了Evermine50 EES的3年安全性和性能结果。

方法

这是一项针对真实世界中患有原发性冠状动脉病变(CAL)患者的前瞻性、上市后单中心研究。纳入因原发性冠状动脉病变导致有症状缺血性心脏病且支架内再狭窄病变(长度<44mm)、参考血管直径为2.0 - 4.5mm且适合经皮冠状动脉腔内血管成形术支架置入术的患者。

结果

共纳入251例患者(平均年龄:58.20岁),其中48.2%患有ST段抬高型心肌梗死,31.5%患有无症状性心肌缺血。平均病变长度为21.81±8.14mm,70.3%的患者术前心肌梗死溶栓(TIMI)血流分级为III级。平均支架长度记录为23.50±12.21mm。98%的患者术后达到TIMI-III血流分级。1年、2年和3年时定义为心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建(CD-TLR)复合终点的主要不良心脏事件累积发生率分别为1.59%、3.58%和3.58%。1至3年CD-TLR累积发生率保持在0.79%不变。3年内无支架血栓形成病例。

结论

本研究表明,超薄的Evermine50 EES在原发性CAL患者中36个月时具有良好的安全性和性能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d30e/12068795/db1833bea879/jcvtr-17-58-g001.jpg

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