Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer

Hyoung Mo Yang, Kyoung Woo Seo, Junghan Yoon, Hyo Soo Kim, Kiyuk Chang, Hong Seok Lim, Byoung Joo Choi, So Yeon Choi, Myeong Ho Yoon, Seunghwan Lee, Sung Gyun Ahn, Youngjin Youn, Junwon Lee, Bon Kwon Koo, Kyung Woo Park, Han Mo Yang, Jung Kyu Han, Ki Bae Seung, Wook Sung Chung, Pum Joon Kim & 3 others Yoon Seok Koh, Hun Jun Park, Seung Jea Tahk

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)898-906
Number of pages9
JournalKorean Circulation Journal
Volume47
Issue number6
DOIs
Publication statusPublished - 2017 Nov 1

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Sirolimus
Stents
Polymers
Drug-Eluting Stents
Thrombosis
Myocardial Infarction
Stable Angina
Mortality
Unstable Angina
Coronary Angiography
Multicenter Studies
Pathologic Constriction
Ischemia
Safety

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Yang, Hyoung Mo ; Seo, Kyoung Woo ; Yoon, Junghan ; Kim, Hyo Soo ; Chang, Kiyuk ; Lim, Hong Seok ; Choi, Byoung Joo ; Choi, So Yeon ; Yoon, Myeong Ho ; Lee, Seunghwan ; Ahn, Sung Gyun ; Youn, Youngjin ; Lee, Junwon ; 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. / Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer. In: Korean Circulation Journal. 2017 ; Vol. 47, No. 6. pp. 898-906.
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title = "Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer",
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.",
author = "Yang, {Hyoung Mo} and Seo, {Kyoung Woo} and Junghan Yoon and Kim, {Hyo Soo} and Kiyuk Chang and Lim, {Hong Seok} and Choi, {Byoung Joo} and Choi, {So Yeon} and Yoon, {Myeong Ho} and Seunghwan Lee and Ahn, {Sung Gyun} and Youngjin Youn and Junwon Lee and Koo, {Bon Kwon} and Park, {Kyung Woo} and Yang, {Han Mo} and Han, {Jung Kyu} and Seung, {Ki Bae} and Chung, {Wook Sung} and Kim, {Pum Joon} and Koh, {Yoon Seok} and Park, {Hun Jun} and Tahk, {Seung Jea}",
year = "2017",
month = "11",
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doi = "10.4070/kcj.2017.0094",
language = "English",
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pages = "898--906",
journal = "Korean Circulation Journal",
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Yang, HM, Seo, KW, Yoon, J, Kim, HS, Chang, K, Lim, HS, Choi, BJ, Choi, SY, Yoon, MH, Lee, S, Ahn, SG, Youn, Y, Lee, J, Koo, BK, Park, KW, Yang, HM, Han, JK, Seung, KB, Chung, WS, Kim, PJ, Koh, YS, Park, HJ & Tahk, SJ 2017, 'Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer', Korean Circulation Journal, vol. 47, no. 6, pp. 898-906. https://doi.org/10.4070/kcj.2017.0094

Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer. / Yang, Hyoung Mo; Seo, Kyoung Woo; Yoon, Junghan; Kim, Hyo Soo; Chang, Kiyuk; Lim, Hong Seok; Choi, Byoung Joo; Choi, So Yeon; Yoon, Myeong Ho; Lee, Seunghwan; Ahn, Sung Gyun; Youn, Youngjin; Lee, Junwon; 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.

In: Korean Circulation Journal, Vol. 47, No. 6, 01.11.2017, p. 898-906.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical and angiographic outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal bioresorbable polymer

AU - Yang, Hyoung Mo

AU - Seo, Kyoung Woo

AU - Yoon, Junghan

AU - Kim, Hyo Soo

AU - Chang, Kiyuk

AU - Lim, Hong Seok

AU - Choi, Byoung Joo

AU - Choi, So Yeon

AU - Yoon, Myeong Ho

AU - Lee, Seunghwan

AU - Ahn, Sung Gyun

AU - Youn, Youngjin

AU - Lee, Junwon

AU - Koo, Bon Kwon

AU - Park, Kyung Woo

AU - Yang, Han Mo

AU - Han, Jung Kyu

AU - Seung, Ki Bae

AU - Chung, Wook Sung

AU - Kim, Pum Joon

AU - Koh, Yoon Seok

AU - Park, Hun Jun

AU - Tahk, Seung Jea

PY - 2017/11/1

Y1 - 2017/11/1

N2 - 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.

AB - 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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