Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer. Issue 19 (14th May 2021)

• Record Type: Journal Article
• Authors: Seo, Kyoung-Woo; Yang, Hyoung-Mo; 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; Chung, Wook-Sung; Park, Hun-Jun; Hwang, Byung-Hee; Choo, Eun-Ho; Oh, Gyu-Chul; Tahk, Seung-Jea
• Other Names: Roever. Leonardo section editor.
• Is Part Of: Medicine. Volume 100:Issue 19(2021)
• Publication Date: 2021-05-14
• Subjects: coronary artery disease -- drug-eluting stents -- Sirolimus; Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000025765
• Languages: English
• ISSNs: 0025-7974

Abstract

Abstract : Abstract: This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer. We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years. We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years. The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.