Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

Abstract

Background and Objectives: Recently, Genoss drug-eluting stent (DES)(TM) stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES (TM) stent. Methods: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES (TM) registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES (TM) stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. Results: Among 622 subjects, the mean age of subjects was 66.5 +/- 10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5 +/- 0.8, 3.1 +/- 0.4 mm, and 36.0 +/- 23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. Conclusions: The novel Genoss DES (TM) stent exhibited excellent safety and efficacy in real-world practice.