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.