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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Mar 26, 2023; 15(3): 84-94
Published online Mar 26, 2023. doi: 10.4330/wjc.v15.i3.84
Published online Mar 26, 2023. doi: 10.4330/wjc.v15.i3.84
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, 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
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
Core Tip
Core Tip: Biodegradable polymer drug-eluting stents (BP-DES) have been proven to minimize restenosis and stent thrombosis. Our study evaluates the safety and effectiveness of FlexyRap® DES at the 5-year clinical response in real-world settings. The study proved the feasibility, safety, and efficacy of the FlexyRap® rapamycin-eluting stent for the treatment of de novo coronary artery disease, indicating low rates of events and stent thrombosis at 5-year follow-up.