Effectiveness and safety of biolimus A9™-eluting stEnt in patients with acUTe coronary syndrome; a multicenter, observational study (BEAUTY study)

Keun Ho Park, Myung Ho Jeong, Young Joon Hong, Youngkeun Ahn, Hyun Kuk Kim, Young Yub Koh, Doo Il Kim, Sang Wook Kim, Weon Kim, Seung-Woon Rha, Jay Young Rhew, Jong Seon Park, Hun Sik Park, Jang Ho Bae, Jang Whan Bae, Seok Kyu Oh, Sung Yun Lee, Seung Wook Lee, Jae Hwan Lee, Sang Yeob LimJang Hyun Cho, Kwang Soo Cha, Jai Keon Chae, Seung Ho Hur, Sun Ho Hwang, Jin Yong Hwang

Research output: Contribution to journalArticle

Abstract

Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

Original languageEnglish
Pages (from-to)72-79
Number of pages8
JournalYonsei Medical Journal
Volume59
Issue number1
DOIs
Publication statusPublished - 2018 Jan 1

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Acute Coronary Syndrome
Multicenter Studies
Stents
Observational Studies
Safety
Myocardial Infarction
Biolimus A9
Incidence
Korea
Registries
Polymers
Thrombosis
Regression Analysis
Confidence Intervals

Keywords

  • Acute coronary syndrome
  • Biodegradable polymer
  • Biolimus-eluting stent

ASJC Scopus subject areas

  • Medicine(all)

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Effectiveness and safety of biolimus A9™-eluting stEnt in patients with acUTe coronary syndrome; a multicenter, observational study (BEAUTY study). / Park, Keun Ho; Jeong, Myung Ho; Hong, Young Joon; Ahn, Youngkeun; Kim, Hyun Kuk; Koh, Young Yub; Kim, Doo Il; Kim, Sang Wook; Kim, Weon; Rha, Seung-Woon; Rhew, Jay Young; Park, Jong Seon; Park, Hun Sik; Bae, Jang Ho; Bae, Jang Whan; Oh, Seok Kyu; Lee, Sung Yun; Lee, Seung Wook; Lee, Jae Hwan; Lim, Sang Yeob; Cho, Jang Hyun; Cha, Kwang Soo; Chae, Jai Keon; Hur, Seung Ho; Hwang, Sun Ho; Hwang, Jin Yong.

In: Yonsei Medical Journal, Vol. 59, No. 1, 01.01.2018, p. 72-79.

Research output: Contribution to journalArticle

Park, KH, Jeong, MH, Hong, YJ, Ahn, Y, Kim, HK, Koh, YY, Kim, DI, Kim, SW, Kim, W, Rha, S-W, Rhew, JY, Park, JS, Park, HS, Bae, JH, Bae, JW, Oh, SK, Lee, SY, Lee, SW, Lee, JH, Lim, SY, Cho, JH, Cha, KS, Chae, JK, Hur, SH, Hwang, SH & Hwang, JY 2018, 'Effectiveness and safety of biolimus A9™-eluting stEnt in patients with acUTe coronary syndrome; a multicenter, observational study (BEAUTY study)', Yonsei Medical Journal, vol. 59, no. 1, pp. 72-79. https://doi.org/10.3349/ymj.2018.59.1.72
Park, Keun Ho ; Jeong, Myung Ho ; Hong, Young Joon ; Ahn, Youngkeun ; Kim, Hyun Kuk ; Koh, Young Yub ; Kim, Doo Il ; Kim, Sang Wook ; Kim, Weon ; Rha, Seung-Woon ; Rhew, Jay Young ; Park, Jong Seon ; Park, Hun Sik ; Bae, Jang Ho ; Bae, Jang Whan ; Oh, Seok Kyu ; Lee, Sung Yun ; Lee, Seung Wook ; Lee, Jae Hwan ; Lim, Sang Yeob ; Cho, Jang Hyun ; Cha, Kwang Soo ; Chae, Jai Keon ; Hur, Seung Ho ; Hwang, Sun Ho ; Hwang, Jin Yong. / Effectiveness and safety of biolimus A9™-eluting stEnt in patients with acUTe coronary syndrome; a multicenter, observational study (BEAUTY study). In: Yonsei Medical Journal. 2018 ; Vol. 59, No. 1. pp. 72-79.
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abstract = "Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8{\%} of the patients were male, 28.5{\%} had diabetes, 32.8{\%} had multi-vessel disease (MVD), and 47.9{\%} presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9{\%} and 0.2{\%}, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95{\%} confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3{\%} vs. 3.7{\%}, p=0.667), between those who presented with and without AMI (4.4{\%} vs. 3.4{\%}, p=0.403), and between those with and without MVD (4.6{\%} vs. 3.5{\%}, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.",
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T1 - Effectiveness and safety of biolimus A9™-eluting stEnt in patients with acUTe coronary syndrome; a multicenter, observational study (BEAUTY study)

AU - Park, Keun Ho

AU - Jeong, Myung Ho

AU - Hong, Young Joon

AU - Ahn, Youngkeun

AU - Kim, Hyun Kuk

AU - Koh, Young Yub

AU - Kim, Doo Il

AU - Kim, Sang Wook

AU - Kim, Weon

AU - Rha, Seung-Woon

AU - Rhew, Jay Young

AU - Park, Jong Seon

AU - Park, Hun Sik

AU - Bae, Jang Ho

AU - Bae, Jang Whan

AU - Oh, Seok Kyu

AU - Lee, Sung Yun

AU - Lee, Seung Wook

AU - Lee, Jae Hwan

AU - Lim, Sang Yeob

AU - Cho, Jang Hyun

AU - Cha, Kwang Soo

AU - Chae, Jai Keon

AU - Hur, Seung Ho

AU - Hwang, Sun Ho

AU - Hwang, Jin Yong

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

AB - Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

KW - Acute coronary syndrome

KW - Biodegradable polymer

KW - Biolimus-eluting stent

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