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

• Youn YJ
• Yoo SY
• Lee JW
• Ahn SG
• Lee SH
• Yoon J
• Park JH
• Choi WG
• Cho S
• Lim SW
• Jang YS
• Kwon KH
• Lee NH
• Doh JH
• Kang WC
• Jeon DW
• Lee BK
• Heo JH
• Hong BK
• Choi HH

• KMID: 2471281
• DOI: http://doi.org/10.4070/kcj.2019.0258

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

MeSH Terms

Death
Drug-Eluting Stents
Follow-Up Studies
Humans
Hypertension
Male
Multicenter Studies as Topic
Myocardial Infarction
Percutaneous Coronary Intervention
Polymers*
Prospective Studies
Registries
Sirolimus
Stents*
Polymers
Sirolimus

Figure

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  Figure 1 The study flow diagram.DES = drug-eluting stent.

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  Figure 2 The Kaplan-Meier survival curves. Event rate was estimated based on the unadjusted Kaplan-Meier method. (A) DOCO; (B) POCO; (C) TLR; and (D) definite and probable stent thrombosis.DOCO = device-oriented composite outcome; POCO = patient-oriented composite outcome; TLR = target lesion revascularization.

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