Clinical Outcomes of Ultrathin Biodegradable Polymer-coated Sirolimus-eluting Stents in an All-comer Population: One-year Results from the T-FLEX Registry Including High-risk Subgroups

Overview

Journal Anatol J Cardiol

Publisher Kare Publishing

Specialty Cardiology & Vascular Diseases

Date 2021 Oct 8

PMID 34622785

Citations 7

Authors

Ramesh Babu Pothineni

Vikrant Vijan

Anil Potdar

Manohar K Inamdar

Abhijit Pathak

Sai Sudhakar Mantravadi

Prakash Ajmera

Affiliations

Soon will be listed here.

Abstract

Objective: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups.

Methods: This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint.

Results: At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population.

Conclusion: Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

Citing Articles

Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry.

Karthikeyan V, Mozid A, Aggarwal S, Kumar A, Hildick-Smith D, Anderson R BMJ Open. 2024; 14(10):e084028.

PMID: 39438097 PMC: 11499841. DOI: 10.1136/bmjopen-2024-084028.

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.

Hudec M, Kupec A, Gazdic P Anatol J Cardiol. 2024; 28(3):142-149.

PMID: 38419511 PMC: 10918283. DOI: 10.14744/AnatolJCardiol.2023.3801.

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study.

Meennahalli Palleda G, Gupta M, Bansal A, Batra V, Tyagi S, Kunal S Cardiol Res. 2023; 14(5):360-369.

PMID: 37936627 PMC: 10627375. DOI: 10.14740/cr1515.

Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stents: Patient-Level Pooled Analysis From Two Indian Registries.

Pothineni R, Ajmera P, Chawla K, Mantravadi S, Pathak A, Inamdar M Cureus. 2023; 15(7):e41743.

PMID: 37575772 PMC: 10415628. DOI: 10.7759/cureus.41743.

Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents.

Polavarapu R, Pamidimukkala V, Polavarapu A, Siripuram Y, Ravella K, Rachaputi M Indian Heart J. 2023; 75(4):279-284.

PMID: 36972762 PMC: 10421990. DOI: 10.1016/j.ihj.2023.03.006.

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