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Effectiveness and Safety of Biolimus A9TM-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)

Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing BiolimusA9TM-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 impl...

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Published in:Yonsei medical journal 2018, 59(1), , pp.72-79
Main Authors: 박근호, 정명호, 홍영준, 안영근, 김현국, 고영엽, 김두일, 김상욱, 김원, 나승운, 류재영, 박종선, 박헌식, 배장호, 배장환, 오석규, 이성윤, 이승욱, 이재환, 임상엽, 조장현, 차광수, 채제건, 허승호, 황선호, 황진용
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container_title Yonsei medical journal
container_volume
creator 박근호
정명호
홍영준
안영근
김현국
고영엽
김두일
김상욱
김원
나승운
류재영
박종선
박헌식
배장호
배장환
오석규
이성윤
이승욱
이재환
임상엽
조장현
차광수
채제건
허승호
황선호
황진용
description Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing BiolimusA9TM-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 Koreawere 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 predictorsof 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. KCI Citation Count: 0
doi_str_mv 10.3349/ymj.2018.59.1.72
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Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Koreawere 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 predictorsof 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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title Effectiveness and Safety of Biolimus A9TM-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)
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