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Lookup NU author(s): Professor Azfar ZamanORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. OBJECTIVE: We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation. STUDY DESIGN: The study was a prospective, observational, multicentre, single-arm registry. STUDY SETTINGS: The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021. STUDY PARTICIPANTS: A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled. PRIMARY AND SECONDARY OUTCOMES MEASURE: The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm). RESULTS: A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20±11.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up. CONCLUSION: The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis. TRIAL REGISTRATION NUMBER: ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665).
Author(s): Karthikeyan VJ, Mozid A, Aggarwal S, Kumar A, Hildick-Smith D, Anderson R, Nair S, Ruparelia N, Curzen N, Veerasamy M, Elsheikh S, Zaman A
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2024
Volume: 14
Issue: 10
Online publication date: 22/10/2024
Acceptance date: 15/09/2024
Date deposited: 04/11/2024
ISSN (print): 2044-6055
ISSN (electronic): 2044-6055
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmjopen-2024-084028
DOI: 10.1136/bmjopen-2024-084028
Data Access Statement: All data relevant to the study are included in the article or uploaded as online supplemental information.
PubMed id: 39438097
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