Safety and performance of the EverPro TM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario.

Autor: Trimukhe R; Department of Cardiology, Atma Malik Hospital, Ahmednagar 423601, Maharashtra, India., Vani P; SLTL Medical Division, SLTL (Sahajanand Laser Technology Ltd.), Gandhinagar 382016, Gujarat, India., Patel A; SLTL Group, SLTL (Sahajanand Laser Technology Ltd.), Gandhinagar 382016, Gujarat, India., Salgotra V; SLTL Medical Division, SLTL (Sahajanand Laser Technology Ltd.), Gandhinagar 382016, Gujarat, India. clinical@sltl.com.
Jazyk: angličtina
Zdroj: World journal of cardiology [World J Cardiol] 2020 Dec 26; Vol. 12 (12), pp. 615-625.
DOI: 10.4330/wjc.v12.i12.615
Abstrakt: Background: The EverPro TM (Sahajanand Laser Technology Ltd., India) everolimus-eluting coronary stent system (EES) is a second-generation drug-eluting stent with a biodegradable polymer.
Aim: To determine the safety and performance of the EverPro TM EES in patients with coronary artery disease (CAD) during a 1-year clinical follow-up.
Methods: This observational, retrospective, single-center study enrolled patients who had been implanted with the EverPro TM stent between June 1, 2018 and January 31, 2019, and had completed a 1-year follow-up period after the index procedure. The primary clinical endpoint was major adverse cardiac events (MACE) at 6 mo defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary endpoints were the incidence of TLR at 1, 6 and 12 mo follow-up, MACE at 1 and 12 mo follow-up, and stent thrombosis up to 1 year after the index procedure.
Results: The study population comprised 77 patients (98 lesions). A total of 37 (48.1%) patients had comorbid hypertension. In total, 26 (33.8%) patients presented with ST segment elevation MI and 10.4% patients with non-ST segment elevation MI. Treated lesions were located mainly in the left anterior descending artery (49%) followed by the right coronary artery (29.6%), left circumflex (12.2%) and obtuse marginal (9.2%) arteries. The majority of patients were with single-vessel disease (79%), 22.2% of lesions had a mild to severe thrombus load, and 94.9% were American College of Cardiology/American Heart Association type B or C. De novo stenting was performed in 96.9% of patients and 3% were treated for in-stent restenosis. Procedural success was attained in all patients. In-hospital or follow-up MACE and stent thrombosis were not reported during the 1-year follow-up period.
Conclusion: These findings suggest that the EverPro TM EES is a safe and effective treatment option with no MACE or stent thrombosis reported during the 1-year study period in patients with CAD.
Competing Interests: Conflict-of-interest statement: Vani P, Patel A, Salgotra V are employees of Sahajanand Laser Technology Ltd., and Dr. Trimukhe R is an employee of Atma Malik Hospital. The authors do not have any other conflicts of interest to declare.
(©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.)
Databáze: MEDLINE