Retrospective Cohort Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Dec 26, 2020; 12(12): 615-625
Published online Dec 26, 2020. doi: 10.4330/wjc.v12.i12.615
Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario
Rahul Trimukhe, Preeti Vani, Arvind Patel, Vikas Salgotra
Rahul Trimukhe, Department of Cardiology, Atma Malik Hospital, Ahmednagar 423601, Maharashtra, India
Preeti Vani, Vikas Salgotra, SLTL Medical Division, SLTL (Sahajanand Laser Technology Ltd.), Gandhinagar 382016, Gujarat, India
Arvind Patel, SLTL Group, SLTL (Sahajanand Laser Technology Ltd.), Gandhinagar 382016, Gujarat, India
Author contributions: Vani P, Patel A, and Salgotra V designed the study; Trimukhe R was involved in data collection, analysis and interpretation; all authors were involved in drafting, reviewing and approved the final version of the manuscript.
Institutional review board statement: The study was reviewed and approved by an Independent Ethics Committee.
Informed consent statement: The study involved retrospective data collection from the medical records in the hospital; therefore, we obtained permission from the head of the institution for data collection.
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.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Vikas Salgotra, MPhil, Senior Researcher, SLTL Medical Division, SLTL (Sahajanand Laser Technology Ltd.), E30, Electronics Estate, GIDC, Sector 26, Gandhinagar 382016, Gujarat, India. clinical@sltl.com
Received: June 18, 2020
Peer-review started: June 18, 2020
First decision: September 18, 2020
Revised: October 15, 2020
Accepted: November 5, 2020
Article in press: November 5, 2020
Published online: December 26, 2020
Processing time: 182 Days and 0.9 Hours
Abstract
BACKGROUND

The EverProTM (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 EverProTM 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 EverProTM 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 EverProTM 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.

Keywords: Coronary artery disease; Everolimus; Major adverse cardiac event; Retrospective, EverProTM, Myocardial infarction

Core Tip: New-generation drug-eluting stents (DES) reduce the risk of stent thrombosis. However, the everolimus-eluting coronary stent system (EES) exerts higher interaction with rapamycin complex 2, higher bioavailability, shorter half-life than sirolimus, decreases vascular inflammation and promotes rapid endothelialization; therefore, outperforms paclitaxel DES in safety and efficacy. EverProTM, a second-generation EES with a biodegradable polymer and a 60 μm cobalt-chromium platform design, facilitates reduction in intra-arterial injury. This observational study enrolled 77 patients with coronary artery disease (CAD), implanted with the EverProTM stent who completed a 1-year follow-up period after the index procedure. Our findings suggested that EverProTM EES is safe and effective with no major adverse cardiac events/stent thrombosis during the 1 year follow-up period in patients with CAD.