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

Abstract

Introduction: The Evermine50^TM (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 de novo 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.