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

Korean Circulation Journal 2020년 50권 4호 p.317 ~ 327
윤영진 ( Youn Young-Jin ) - Yonsei University Wonju College of Medicine Wonju Severance Christian Hospital Department of Internal Medicine

유상용 ( Yoo Sang-Yong ) - University of Ulsan College of Medicine Gangneung Asan Hospital Department of Internal Medicine
이준원 ( Lee Jun-Won ) - Yonsei University Wonju College of Medicine Wonju Severance Christian Hospital Department of Internal Medicine
안성균 ( Ahn Sung-Gyun ) - Yonsei University Wonju College of Medicine Wonju Severance Christian Hospital Department of Internal Medicine
이승환 ( Lee Seung-Hwan ) - Yonsei University Wonju College of Medicine Wonju Severance Christian Hospital Department of Internal Medicine
윤정한 ( Yoon Jung-Han ) - Yonsei University Wonju College of Medicine Wonju Severance Christian Hospital Department of Internal Medicine
박재형 ( Park Jae-Hyoung ) - Korea University Anam Hospital Department of Cardiology
최웅길 ( Choi Woong-Gil ) - Konkuk University School of Medicine Konkuk University Chungju Hospital Department of Internal Medicine
조성수 ( Cho Sung-Soo ) - Dankook University College of Medicine Dankook University Hospital Department of Internal Medicine
임상욱 ( Lim Sang-Wook ) - CHA University CHA Bundang Medical Center Department of Internal Medicine
장양수 ( Jang Yang-Soo ) - Ewha Womans University School of Medicine Ewha Womans University Mokdong Hospital Department of Internal Medicine
권기환 ( Kwon Ki-Hwan ) - Hallym University Kangnam Sacred Heart Hospital Department of Internal Medicine
이남호 ( Lee Nam-Ho ) - Inje University Ilsan Paik Hospital Department of Internal Medicine
도준형 ( Doh Joon-Hyung ) - Inje University Ilsan Paik Hospital Department of Internal Medicine
강웅철 ( Kang Woong-Chol ) - Gachon University Gil Medical Center Department of Internal Medicine
전동운 ( Jeon Dong-Woon ) - National Health Insurance Service Ilsan Hospital Department of Internal Medicine
이봉기 ( Lee Bong-Ki ) - Kangwon National University School of Medicine Kangwon National University Hospital Department of Internal Medicine
허정호 ( Heo Jung-Ho ) - Kosin University Gospel Hospital Department of Internal Medicine Division of Cardiology
홍범기 ( Hong Bum-Kee ) - Yonsei University College of Medicine Gangnam Severance Hospital Division of Cardiology
최현희 ( Choi Hyun-Hee ) - Hallym University College of Medicine Chuncheon Sacred Heart Hospital Division of Cardiology

Abstract


Background and Objectives: Recently, Genoss drug-eluting stent (DES)™ 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 DES™ stent.

Methods: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ 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 DES™ stent exhibited excellent safety and efficacy in real-world practice.

키워드

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