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The Anatolian Journal of Cardiology 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. Ahead of Print: AJC-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 Pothineni1, Vikrant Vijan2, Anil Potdar3, Manohar K Inamdar4, Abhijit Pathak5, Sai Sudhakar Mantravadi6, Prakash Ajmera7
1Department of Cardiology, Ramesh Hospitals, Vijayawada, Andhra Pradesh–520008, India
2Department of Cardiology, Vijan Hospital and Research Centre, Nashik, Maharashtra–422005, India
3Department of Cardiology, Parisoha Foundation Pvt. Ltd., Mumbai, Maharashtra–400086, India
4Department of Cardiology, Ashwini Hospital, Akluj, Maharashtra–413101, India
5Department of Cardiology, Swasthya Hospital And Medical Research Center, Ahmednagar, Maharashtra–414001, India
6Department of Cardiology, Gleneagles Global Hospital, Hyderabad, Telangana–500004, India
7Department of Cardiology, Malla Reddy Narayana Multispeciality Hospital, Hyderabad, Telangana–500055, India

Objective: T-Flex Registry was designed to investigate 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, investigator-initiated retrospective registry. A total of 1203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, co-morbidities and acute presentation, from May-2016 to Jan-2017 were analyzed. Primary endpoint was 1-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 1-year follow-up, TLF was observed in 3.8% (95% 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 1-year was 6.8% (95% CI: 4.6–9.8) in diabetic patients, 5.2% (95% CI: 3.4–8) in small-vessel disease patients, 6.1% (95% CI: 3.9-9.6) in ST-elevation myocardial infarction patients, and 4.5% (95% CI: 2.4-8.3) in total occlusion patients. 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 1-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



Corresponding Author: Ramesh Pothineni, India