Evaluation of Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in an All-Comers Patient Population: 1-Year Results of the S-FLEX Slovakia Registry.

Publisher: KARE publishing Country of Publication: Turkey NLM ID: 101652981 Publication Model: Print Cited Medium: Internet ISSN: 2149-2271 (Electronic) Linking ISSN: 21492263 NLM ISO Abbreviation: Anatol J Cardiol Subsets: MEDLINE

Publication: 2023- : İstanbul, Turkey : KARE publishing
Original Publication: İstanbul, Turkey : Aves, [2015]-

Coronary Artery Disease*/surgery ; Diabetes Mellitus*/epidemiology ; Drug-Eluting Stents* ; Myocardial Infarction*/epidemiology ; Percutaneous Coronary Intervention*/methods ; Thrombosis*; Humans ; Polymers ; Prospective Studies ; Registries ; Sirolimus ; Slovakia/epidemiology ; Stents ; Treatment Outcome

Background: Supraflex (Sahajanand Medical Technologies Limited, Surat, India) is a new-generation, biodegradable polymer-coated sirolimus-eluting stent (SES) designed on an ultrathin (60 µm) cobalt-chromium platform with a flexible 'S-link.' The S-FLEX Slovakia registry aimed to assess the safety and effectiveness of Supraflex SES in an all-comers population, with a subgroup of diabetic patients.
Methods: This was a prospective, observational, multi-center, post-market registry conducted between February 2018 and May 2019. All consecutive patients with symptomatic coronary artery disease scheduled for percutaneous coronary intervention with Supraflex SES were enrolled. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR) by percutaneous or surgical methods at 1-year follow-up. Stent thrombosis was a safety endpoint.
Results: A total of 413 patients was assessed (145 diabetics and 268 nondiabetics). At 1-year follow-up, the primary endpoint of TLF occurred in 5.1% patients, comprised of 3.9% cardiac deaths, 0.5% TV-MI, and 0.7% CI-TLR. Overall stent thrombosis occurred in 0.5% patients at 1-year follow-up. In the subgroup analysis, TLF occurred in 6.2% diabetics and 4.5% nondiabetics (P =.433) and comprised 4.8% and 3.4% cardiac deaths (P =.447), 0.7% and 0.4% TV-MI (P =.653), and 0.7%, and 0.7% CI-TLR (P =.952) in diabetics and non-diabetics, respectively. Overall stent thrombosis occurred in 0.7% diabetic and 0.4% non-diabetic patient (P =.659).
Conclusion: This registry demonstrates favourable clinical outcomes after the implantation of the ultrathin biodegradable polymer coated Supraflex SES in an all-comers population, with event rates that were similar in diabetic and nondiabetic patients.

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0 (Polymers)
W36ZG6FT64 (Sirolimus)

Date Created: 20240229 Date Completed: 20240301 Latest Revision: 20240309

20240309

PMC10918283

10.14744/AnatolJCardiol.2023.3801

38419511