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Volume : 25 Issue : 10 Year : 2021
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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 [Anatol J Cardiol]
Anatol J Cardiol. 2021; 25(10): 706-715 | DOI: 10.5152/AnatolJCardiol.2021.78291

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

Ramesh Babu Pothineni1, Vikrant Vijan2, Anil Potdar3, Manohar K. Inamdar4, Abhijit Pathak5, Sai Sudhakar Mantravadi6, Prakash Ajmera7
1Department of Cardiology, Ramesh Hospitals; Andhra Pradesh–India
2Department of Cardiology, Vijan Hospital and Research Centre; Maharashtra–India
3Department of Cardiology, Parisoha Foundation Pvt. Ltd.; Mumbai–India
4Department of Cardiology, Ashwini Hospital; Maharashtra–India
5Department of Cardiology, Swasthya Hospital and Medical Research Center; Maharashtra–India
6Department of Cardiology, Gleneagles Global Hospital; Telangana–India
7Department of Cardiology, Malla Reddy Narayana Multispeciality Hospital; Telangana–India

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.

Keywords: biodegradable polymer, percutaneous coronary intervention, sirolimus-eluting stent, stent thrombosis, target lesion failure, ultrathin strut

Ramesh Babu Pothineni, Vikrant Vijan, Anil Potdar, Manohar K. Inamdar, Abhijit Pathak, Sai Sudhakar Mantravadi, Prakash Ajmera. 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. Anatol J Cardiol. 2021; 25(10): 706-715

Corresponding Author: Ramesh Babu Pothineni, India