Safety and performance of everolimus-eluting stents comprising of biodegradable polymers with ultrathin stent platforms.

Abstract

The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.