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Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test

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Author(s)
Chang-Hwan YoonJihong JangSeung Ho HurJun-Hee LeeSeung Hwan HanSoon-Jun HongKiyuk ChangIn-Ho Chae
Keimyung Author(s)
Hur, Seung Ho
Department
Dept. of Internal Medicine (내과학)
Journal Title
Korean Circ J
Issued Date
2022
Volume
52
Issue
5
Keyword
Coronary diseasePercutaneous coronary interventionDrug-eluting stentsCoronary restenosis
Abstract
Background and objectives:
To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience).

Methods:
This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization.

Results:
We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group.

Conclusions:
The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.
Keimyung Author(s)(Kor)
허승호
Publisher
School of Medicine (의과대학)
Citation
Chang-Hwan Yoon et al. (2022). Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test. Korean Circ J, 52(5), 354–364. doi: 10.4070/kcj.2021.0198
Type
Article
ISSN
1738-5555
Source
https://e-kcj.org/DOIx.php?id=10.4070/kcj.2021.0198
DOI
10.4070/kcj.2021.0198
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44202
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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