Effectiveness and Safety of CENTUM™, an Everolimus-Eluting Stent, in Patients With Coronary Artery Disease: A Prospective Multi-Center Observational Study.

Abstract

Background and objectives: CENTUM is a biodegradable everolimus-eluting stent comprising a cobalt-chromium open-cell stent platform. In this prospective trial, we aimed to evaluate the effectiveness and safety of CENTUM™ in a clinical setting.

Methods: A prospective, single-arm, multi-center observational registry was designed to assess the clinical outcomes after CENTUM implantation in all-comers who underwent percutaneous coronary intervention. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization at 12 months. The secondary endpoints included stent thrombosis and other clinical events (all-cause death, myocardial infarction, stroke, target vessel revascularization, and bleeding).

Results: Total 490 patients were enrolled, and 451 completed the study. The mean age was 67.1 years, and 52.8% of the patients presented with acute coronary syndrome. The primary endpoint was observed in 1.11% of the patients. Definite/probable stent thrombosis was observed in 0.44% of the patients, whereas total clinical events recorded was 4.43%.

Conclusions: CENTUM was effective and safe at 12 months in all patients who underwent percutaneous coronary intervention. Our findings support the broader application of CENTUM in patients with coronary artery disease.

Trial registration: Clinical Research Information Service Identifier: KCT0009898.