Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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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

  • Chang-Hwan Yoon (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Jihong Jang (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Seung Ho Hur (Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Medical Center) ;
  • Jun-Hee Lee (Division of Cardiology, Department of Internal Medicine, Kangdong Sacred Heart Hospital) ;
  • Seung Hwan Han (Division of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Soon-Jun Hong (Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital) ;
  • Kiyuk Chang (Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea Seoul St. Mary's Hospital) ;
  • In-Ho Chae (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital)
  • Received : 2021.06.03
  • Accepted : 2021.12.07
  • Published : 2022.05.01
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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.

Keywords

Acknowledgement

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI18C2332).

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