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KMID : 0368120170470060898
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Korean Circulation Journal
2017 Volume.47 No. 6 p.898 ~ p.906
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Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer
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Yang Hyoung-Mo
Seo Kyoung-Woo
Yoon Jung-Han
Kim Hyo-Soo
Chang Ki-Yuk
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
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Abstract
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Background and Objectives: This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent.
Methods: 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.
Results: 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.
Conclusion: 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.
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KEYWORD
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Drug-eluting stents, Coronary artery disease, Sirolimus
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