Korean Circ J.  2020 Apr;50(4):317-327. 10.4070/kcj.2019.0258.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

Affiliations
  • 1Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea. jyoon@yonsei.ac.kr
  • 2Division of Cardiology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
  • 3Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University, Seoul, Korea.
  • 4Division of Cardiology, Department of Internal Medicine, Konkuk University Chungju Hospital, Konkuk University College of Medicine, Chungju, Korea.
  • 5Division of Cardiovascular Medicine, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea.
  • 6Division of Cardiology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
  • 7Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea.
  • 8Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea.
  • 9Division of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University, Goyang, Korea.
  • 10Department of Cardiology, Gachon University Gil Medical Center, Gachon University, Incheon, Korea.
  • 11Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 12Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
  • 13Department of Internal Medicine, Kangwon National University Hospital, Kangwon National University, Chuncheon, Korea.
  • 14Division of cardiology, Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University, Busan, Korea.
  • 15Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 16Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.

Abstract

BACKGROUND AND OBJECTIVES
Recently, Genoss drug-eluting stent (DES)â„¢ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DESâ„¢ stent.
METHODS
We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DESâ„¢ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DESâ„¢ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.
RESULTS
Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.
CONCLUSIONS
The novel Genoss DESâ„¢ stent exhibited excellent safety and efficacy in real-world practice.

Keyword

Drug-eluting stents; Percutaneous coronary intervention; Prospective studies; Registries
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