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

• Published in: Korean circulation journal Vol. 47; no. 6; pp. 898 - 906
• Main Authors: Yang, Hyoung-Mo, Seo, Kyoung-Woo, Yoon, Junghan, Kim, Hyo-Soo, Chang, Kiyuk, Lim, Hong-Seok, Choi, Byoung-Joo, Choi, So-Yeon, Yoon, Myeong-Ho, Lee, Seung-Hwan, Ahn, Sung Gyun, Youn, Young Jin, Lee, Jun-Won, Koo, Bon-Kwon, Park, Kyung Woo, Yang, Han-Mo, Han, Jung-Kyu, Seung, Ki-Bae, Chung, Wook-Sung, Kim, Pum-Joon, Koh, Yoon-Seok, Park, Hun-Jun, Tahk, Seung-Jea
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society of Cardiology 01.11.2017; 대한심장학회
• Subjects: Original; 내과학; Sirolimus; Coronary artery disease; Drug-eluting stents
• ISSN: 1738-5520; 1738-5555
• DOI: 10.4070/kcj.2017.0094

This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent. This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent (DES)™ and Promus Element™. 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 ≤40 mm. 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. We enrolled 38 patients for the Genoss DES™ group and 39 patients for the Promus Element™ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups (0.11±0.25 vs. 0.16±0.43 mm, 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. This first-in-patient study of the Genoss DES™ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.