Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer
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 sil...
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| Published in | Korean circulation journal Vol. 47; no. 6; pp. 898 - 906 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Korea (South)
The Korean Society of Cardiology
01.11.2017
대한심장학회 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1738-5520 1738-5555 |
| DOI | 10.4070/kcj.2017.0094 |
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| Abstract | 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. |
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| AbstractList | 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. 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. KCI Citation Count: 2 This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent.BACKGROUND AND OBJECTIVESThis 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.METHODSThis 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.RESULTSWe 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.CONCLUSIONThis 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. |
| Author | Koo, Bon-Kwon Tahk, Seung-Jea Seung, Ki-Bae Han, Jung-Kyu Park, Hun-Jun Koh, Yoon-Seok Yoon, Myeong-Ho Seo, Kyoung-Woo Yang, Han-Mo Park, Kyung Woo Kim, Pum-Joon Yoon, Junghan Yang, Hyoung-Mo Kim, Hyo-Soo Chang, Kiyuk Choi, So-Yeon Choi, Byoung-Joo Lee, Seung-Hwan Chung, Wook-Sung Youn, Young Jin Lee, Jun-Won Lim, Hong-Seok Ahn, Sung Gyun |
| AuthorAffiliation | 4 Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea 1 Department of Cardiology, Ajou University School of Medicine, Suwon, Korea 2 Department of Cardiology, Yonsei University Wonju Christian Hospital, Wonju, Korea 3 Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea |
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| Cites_doi | 10.1161/CIRCULATIONAHA.106.675934 10.1016/S0140-6736(08)61244-1 10.1093/eurheartj/ehs086 10.1161/CIRCINTERVENTIONS.108.823443 10.1161/01.CIR.0000116202.41966.D4 10.1016/j.ijcard.2014.03.167 10.1016/j.jacc.2006.03.042 10.1016/S0735-1097(01)01175-5 10.1056/NEJMoa012843 10.1016/j.jcin.2009.07.007 10.4244/EIJV7I1A15 10.1056/NEJMoa067193 10.1161/CIRCULATIONAHA.106.685313 10.1056/NEJMoa035071 10.1056/NEJMoa032441 10.1016/j.jacc.2005.07.071 |
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| Keywords | Sirolimus Coronary artery disease Drug-eluting stents |
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This study was a prospective, multicenter, randomized trial with a 1:1... This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent.BACKGROUND AND OBJECTIVESThis trial evaluated the safety and efficacy of... Background and Objectives: This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent. Methods: This study was a prospective,... |
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| Title | Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer |
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