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BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

Authors
 Chang-Hwan Yoon  ;  Ju-Seung Kwun  ;  Young Jin Choi  ;  Jin Joo Park  ;  Si-Hyuck Kang  ;  Sun-Hwa Kim  ;  Jung-Won Suh  ;  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 
Citation
 CIRCULATION-CARDIOVASCULAR INTERVENTIONS, Vol.16(1) : e012307, 2023-01 
Journal Title
CIRCULATION-CARDIOVASCULAR INTERVENTIONS
ISSN
 1941-7640 
Issue Date
2023-01
MeSH
Absorbable Implants ; Coronary Artery Disease* / diagnostic imaging ; Coronary Artery Disease* / therapy ; Drug-Eluting Stents* ; Everolimus / adverse effects ; Humans ; Percutaneous Coronary Intervention* / adverse effects ; Polymers ; Prospective Studies ; Prosthesis Design ; Sirolimus / adverse effects ; Treatment Outcome
Keywords
coronary artery disease ; drug-eluting stent ; ischemia ; percutaneous coronary intervention ; sirolimus
Abstract
Background: Comparative studies of ultrathin-strut biodegradable polymer sirolimus-eluting stent (BP-SES) have reported promising results and validated its excellent outcomes in terms of safety and efficacy. However, there are limited studies comparing BP drug-eluting stents with struts of different thicknesses. We compared the long-term clinical outcomes of patients treated with an ultrathin-strut BP-SES or a thick-strut biodegradable polymer biolimus-eluting stent (BP-BES). Methods: The BIODEGRADE trial (Biomatrix and Orsiro Drug-Eluting Stents in Angiographic Result in Patients With Coronary Artery Disease) is a multicenter prospective randomized study comparing coronary revascularization in patients with ultrathin-strut BP-SES and thick-strut BP-BES with the primary end point of target lesion failure at 18 months posttreatment. We performed the prespecified analysis of 3-year clinical outcomes. Results: In total, 2341 patients were randomized to receive treatment with ultrathin-strut BP-SES (N=1175) or thick-strut BP-BES (N=1166). The 3-year incidence rate of target lesion failure was 3.2% for BP-SES and 5.1% for BP-BES (P=0.023). The difference was primarily due to differences in ischemia-driven target lesion revascularization (BP-SES, 1.5%; BP-BES, 2.8%; P=0.035) between groups. A landmark analysis of the late follow-up period showed significant differences in target lesion failure, with outcomes being better in BP-SES. Cardiac death and target lesion revascularization were significantly lower in the BP-SES group. Conclusions: In a large, randomized trial, the long-term clinical outcome of target lesion failure at 3 years was significantly better among patients treated with the ultrathin-strut BP-SES. The results indicate the superiority of the ultrathin-strut BP-SES compared with the thick-strut BP-BES. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02299011. © 2023 Lippincott Williams and Wilkins. All rights reserved.
Full Text
https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.122.012307
DOI
10.1161/CIRCINTERVENTIONS.122.012307
Appears in Collections:
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
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198198
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