Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer.
- Author:
Hyoung Mo YANG
1
;
Kyoung Woo SEO
;
Junghan YOON
;
Hyo Soo KIM
;
Kiyuk CHANG
;
Hong Seok LIM
;
Byoung Joo CHOI
;
So Yeon CHOI
;
Myeong Ho YOON
;
Seung Hwan LEE
;
Sung Gyun AHN
;
Young Jin YOUN
;
Jun Won LEE
;
Bon Kwon KOO
;
Kyung Woo PARK
;
Han Mo YANG
;
Jung Kyu HAN
;
Ki Bae SEUNG
;
Wook Sung CHUNG
;
Pum Joon KIM
;
Yoon Seok KOH
;
Hun Jun PARK
;
Seung Jea TAHK
Author Information
- Publication Type:Multicenter Study ; Original Article
- Keywords: Drug-eluting stents; Coronary artery disease; Sirolimus
- MeSH: Angina, Stable; Angina, Unstable; Constriction, Pathologic; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Ischemia; Mortality; Myocardial Infarction; Polymers*; Prospective Studies; Sirolimus; Stents*; Thrombosis
- From:Korean Circulation Journal 2017;47(6):898-906
- CountryRepublic of Korea
- Language:English
- Abstract: 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.
