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.