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BioMatrix versus Orsiro biodegradable polymer stents in all- comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial

 Chang-Hwan Yoon  ;  Young Jin Choi  ;  Jin Joo Park  ;  Si-Hyuck Kang  ;  Sun-Hwa Kim  ;  Jung-Won Suh  ;  Young-Seok Cho  ;  Tae-Jin Youn  ;  Myeong-Kon Kim  ;  Kwang Soo Cha  ;  Seung-Hwan Lee  ;  Bum-Kee Hong  ;  Seung-Woon Rha  ;  Woong-Chol Kang  ;  Jae-Hwan Lee  ;  Sang-Hyun Kim  ;  In-Ho Chae 
 EUROINTERVENTION, Vol.16(17) : 1404-1412, 2021-04 
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Absorbable Implants ; Coronary Artery Disease* / diagnostic imaging ; Coronary Artery Disease* / surgery ; Drug-Eluting Stents* / adverse effects ; Humans ; Middle Aged ; Percutaneous Coronary Intervention* / adverse effects ; Polymers ; Prosthesis Design ; Treatment Outcome
Aims: The aim of this trial was to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix).

Methods and results: This randomised, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF). Between July 2014 and September 2017, we randomly assigned 2,341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2,327 patients who completed 18-month follow-up. The mean patient age was 63.5 years, and 1,565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio [HR] 0.70, upper limit of one-sided 95% confidence interval: 1.18, p for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs 12 [1.0%], p=0.558), target lesion-related myocardial infarction (0 [0%] vs 3 [0.3%], p=0.250), target lesion revascularisation (18 [1.6%] vs 10 [0.9%], p=0.124), or stent thrombosis (0 [0%] vs 2 [0.2%], p=0.50).

Conclusions: In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed good clinical outcomes.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
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