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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Real-world five-year outcomes of FlexyRap® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease
Nitish Garg, Raman Chawla, Vivek Tandon, Deepak Garg, Nilesh Parshottam, Preeti Vani, Malte Neuss
Nitish Garg, Department of Interventional Cardiology, Cardinova Hospital, Jalandhar 144001, India
Raman Chawla, Department of Interventional Cardiology, CareMax Hospital, Jalandhar 144001, India
Vivek Tandon, Department of Interventional Cardiology, EMC Hospital, Amritsar 143001, India
Deepak Garg, Department of Interventional Cardiology, Moga Medicity Hospital, Moga 142001, India
Nilesh Parshottam, Department of Interventional Cardiology, Sunshine Global Hospital, Surat 394370, India
Preeti Vani, Malte Neuss, Medical Division, Sahajanand Laser Technology Ltd., Gandhinagar, Gujarat, 382028, India
Author contributions: Vani P concept and study design, Neuss M, Garg N, Chawla R, Tandon V, Garg D, Parshottam N performed the research; All authors have reviewed and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the OM Institutional Ethics Committee.
Informed consent statement: As per ICH guidelines - E6 (R2/4.8), there is a need to obtain informed consent from subjects in the case of prospective/RCT/Observational clinical studies/investigations. However, in the case of Retrospective post-market clinical follow-up studies, where data collection is done from the hospital records, the permission for the patient (Anonymous) data collection shall be taken from the E/IRB/Head of the Institution from the medical records and not mandatorily requires Informed consent from the patient.
Conflict-of-interest statement: Ms. Preeti and Dr. Malte are employees of Sahajanand Laser Technology Ltd. (SLTL), India. All other authors have nothing to disclose.
Data sharing statement: No additional data are available.
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 NonCommercial (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:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Preeti Vani, MSc, Researcher, Medical Division, Sahajanand Laser Technology Limited, A-8, G.I.D.C, Electronic Estate, Sec-25, Gandhinagar 382028, India. clinical@sltl.com
Received: November 6, 2022
Peer-review started: November 6, 2022
First decision: January 3, 2023
Revised: January 27, 2023
Accepted: March 3, 2023
Article in press: March 3, 2023
Published online: March 26, 2023
Processing time: 135 Days and 0.9 Hours
ARTICLE HIGHLIGHTS
Research background
Drug-eluting stents manufactured with biodegradable polymers (BP-DES) effectively reduce restenosis and the risk of stent thrombosis.
Research motivation
The motivation of the present study is focused on the safety and effectiveness from the stent eluting rapamycin for treating the de novo coronary artery disease (CAD).
Research objectives
Our study evaluates the safety and effectiveness of FlexyRap® DES at the 5-year clinical response in real-world settings. The outcome of the study proved to be viable, safe, and efficacious results of the FlexyRap®, rapamycin-eluting stent for treating de novo CAD, indicating low rates of events and ST at 5-year follow-up.
Research methods
Findings from a retrospective, multi-center, observational, post-market clinical follow-up study of individuals treated with FlexyRap® DES for de novo CAD. During the 12-mo follow-up, the primary endpoint was to determine the rate of target lesion failure (TLF). TLF was established as the culmination of three events: Death caused by cardiovascular issues, a myocardial infarction in the target vessel, and the requirement for revascularization of the target lesion due to clinical findings.
Research results
The major adverse cardiac event rate at 12-mo, 3-year, and 5-year follow-up was 1 (0.2%), 0 (0%) and 1 (0.2%) respectively with 0 (0%) cardiovascular death, 2 (0.4%) TV-MI and 0 (0%) TLR compositely. Furthermore, late stent thrombosis was found in 2 (0.4%) patients at the follow-up of 12-mo, very late stent thrombosis was observed in 2 patients (0.4%) at 3-year follow-up.
Research conclusions
In conclusion, this PMCF study investigated the preliminary indications of the feasibility, safety, and effectiveness of using the FlexyRap® rapamycin-eluting stent for treating de novo lesion in CAD. In the present study, FlexyRap® DES was found to have clinical benefits in treating patients with CAD in a real-world setting.
Research perspectives
To improve the inner luminal diameter and decrease the likelihood of repeat blockages in the treatment of de novo lesions in the native coronary arteries.
