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
ARTICLE HIGHLIGHTS
Research background

The increasing prevalence of coronary artery disease (CAD) has caused significantly higher rates of morbidity and mortality worldwide. Thus, percutaneous coronary intervention, a revascularization modality to treat CAD, restores blood supply to myocardial tissues. Antiproliferative drugs in second-generation drug-eluting stents (DES) inhibit mammalian target of rapamycin and affect stent restenosis. However, EverProTM, an approved second-generation everolimus-eluting coronary stent system (EES) with a biodegradable polymer facilitates a reduction in intra-arterial injury.

Research motivation

Sirolimus has a longer half-life, lower bioavailability and does not directly affect stent restenosis. However, everolimus outperforms sirolimus and can decrease vascular inflammation and promote rapid endothelialization. These findings indicate the potential of EES to replace second-generation DES and impart benefits to patients with CAD.

Research objectives

The objectives of this study were to determine the safety and performance of EverProTM EES in a real-world scenario and to translate its use in the real world as an effective alternative to DES for the treatment of CAD. The EverProTM EES could offer various benefits in addition to reduced stent restenosis and rapid endothelialization.

Research methods

This single-center, observational study enrolled patients who completed a 1-year follow-up period after being implanted with the EverProTM stent (between June 1, 2018 and January 31, 2019). As no hypothesis was tested in the study, we did not perform a formal sample size calculation and included patients who met the eligibility criteria during the stipulated time.

Research results

Of the 102 lesions detected in the included patients, 98 lesions were treated by implantation of the EverProTM stent. 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 with no in-hospital major adverse cardiac events (MACE) or stent thrombosis observed throughout the follow-up period. However, the results were limited by the study’s observational nature, retrospective data analysis and a shorter follow-up period.

Research conclusions

The results showed that EverProTM EES is a safe and effective treatment alternative as no MACE or stent thrombosis was observed during the 1-year study period in patients with CAD.

Research perspectives

The data on the use of the EverProTM stent in the treatment of CAD are very promising. However, if future studies can overcome the study limitation by conducting well-designed studies with a larger sample size and a longer follow-up duration, EverProTM EES can be used as an alternative to contemporary DES for treating CAD.