1.Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice
Young Jin YOUN ; Jun-Won LEE ; Sung Gyun AHN ; Seung-Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Sang-Yong YOO ; Woong Chol KANG ; Nam Ho LEE ; Ki Hwan KWON ; Joon Hyung DOH ; Sang-Wook LIM ; Yang Soo JANG ; Dong Woon JEON ; Jung Ho HEO ; Woong Gil CHOI ; Sungsoo CHO ; Bong-Ki LEE ; Hyonju JEONG ; Bum-Kee HONG ; Hyun-Hee CHOI
The Korean Journal of Internal Medicine 2023;38(5):683-691
Background/Aims:
The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention.
Methods:
The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.
Results:
A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%.
Conclusions
In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.
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