Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer

Background and Objectives: This trial evaluated the safety and efficacy of the Genoss drugeluting coronary stent. Methods: This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent $(DES)^{TM}$ and Promus $Element^{TM}$. Inclusion criteria were the presence of stable angina, unstable angina, or silent ischemia. Angiographic inclusion criteria were de novo coronary stenotic lesion with diameter stenosis >50%, reference vessel diameter of 2.5-4.0 mm, and lesion length ${\leq}40mm$. The primary endpoint was in-stent late lumen loss at 9-month quantitative coronary angiography follow-up. Secondary endpoints were in-segment late lumen loss, binary restenosis rate, death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis during 9 months of follow-up. Results: We enrolled 38 patients for the Genoss $DES^{TM}$ group and 39 patients for the Promus $Element^{TM}$ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups ($0.11{\pm}0.25$ vs. $0.16{\pm}0.43mm$, p=0.567). There was no MI or stent thrombosis in either group. The rates of death (2.6% vs. 0%, p=0.494), TLR (2.6% vs. 2.6%, p=1.000), and TVR (7.9% vs. 2.6%, p=0.358) at 9 months were not significantly different. Conclusion: This first-in-patient study of the Genoss $DES^{TM}$ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.