• Kyoung-Woo Seo, Hyoung-Mo Yang, Junghan Yoon, Hyo-Soo Kim, Kiyuk Chang, Hong-Seok Lim, Byoung-Joo Choi, So-Yeon Choi, Yoon Myeong-Ho MH Department of Cardiology, Ajou University School of Medicine, Suwon., Seung-Hwan Lee, Sung Gyun Ahn, Young Jin Youn, Jun-Won Lee, Bon-Kwon Koo, Kyung Woo Park, Han-Mo Yang, Jung-Kyu Han, Wook-Sung Chung, Hun-Jun Park, Byung-Hee Hwang, Eun-Ho Choo, Gyu-Chul Oh, and Seung-Jea Tahk.
• Department of Cardiology, Ajou University School of Medicine, Suwon.
• Medicine (Baltimore). 2021 May 14; 100 (19): e25765.

AbstractThis 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.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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