Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in "Real-World" Patients: A Multicenter Registry (PERFORM-EVER).

Abstract

Background:Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt–chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in “real-world” clinical practice.Methods:The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimus-eluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All “real-world” patients who had received Tetrilimus everolimus-eluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint.Results:During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up. Conclusion:Low incidences of target lesion failure and stent thrombosis at 1-year follow-up indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.