Garg N, Chawla R, Tandon V, Garg D, Parshottam N, Vani P, Neuss M. Real-world five-year outcomes of FlexyRap® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease. World J Cardiol 2023; 15(3): 84-94 [PMID: 37033681 DOI: 10.4330/wjc.v15.i3.84]
Corresponding Author of This Article
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
Research Domain of This Article
Cardiac & Cardiovascular Systems
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which 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/
World J Cardiol. Mar 26, 2023; 15(3): 84-94 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/
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
Abstract
BACKGROUND
The use of biodegradable polymer drug-eluting stents (BP-DES) has been proven to minimize restenosis and stent thrombosis. The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap® DES in the real world.
AIM
To assess the safety and effectiveness of FlexyRap® DES at the 5-year follow-up in real-world settings.
METHODS
Findings from a retrospective, multi-center, observational, post-market clinical follow-up study of patients treated with FlexyRap® DES for de novo coronary artery disease (CAD) were reported. During the 12-mo follow-up, the primary endpoint was target lesion failure, which was defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization.
RESULTS
The data of 500 patients received with FlexyRap® DES was obtained at the completion of the surveillance timeline of 5-year. After the implantation of FlexyRap® DES, the device success rate was 100%. Adverse events that led to major bleeding, permanent disability, or death were not experienced in the patients. 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.
CONCLUSION
FlexyRap® DES was proved to be safe and efficacious in real-world patients with de novo CAD, indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.
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.
