BIONICS Evaluates Safety and Efficacy of Medinol's Ridaforolimus-Eluting Stent
August 18, 2017—Primary results from the BIONICS trial were published online ahead of print by David E. Kandzari, MD, et al in Circulation. BIONICS was designed to determine the safety and efficacy of a ridaforolimus-eluting stent (RES) versus a slow-release zotarolimus-eluting stent (ZES).
This study compared the EluNIR device (Medinol Ltd., named BioNIR in the study), a cobalt alloy-based coronary stent that has a durable elastomeric polymer and elutes the antiproliferative agent ridaforolimus, to the slow-release Endeavor coronary ZES (Medtronic) in patients with coronary artery disease undergoing percutaneous coronary intervention.
The prospective, international, 1:1 randomized BIONICS trial enrolled 1,919 patients at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. The primary endpoint was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel–related myocardial infarction, and target lesion revascularization.
The investigators reported that baseline clinical and angiographic characteristics were similar between the groups. Overall, the mean age was 63.4 years, 32.5% of patients were diabetic, and 39.7% presented with acute coronary syndromes. At 12 months, target lesion failure was 5.4% for both devices (upper bound of one-sided 95% confidence interval, 1.8%; Pnoninferiority = .001).
Definite/probable stent thrombosis rates were low in both groups (0.4% RES vs 0.6% ZES; P = .75). Thirteen-month angiographic in-stent late lumen loss was 0.22 ± 0.41 mm for the RES group and 0.23 ± 0.39 mm for the ZES group (Pnoninferiority = .004), and intravascular ultrasound percent neointimal hyperplasia was 8.1 ± 5.81 for the RES group and 8.85 ± 7.77 for the ZES group (Pnoninferiority = .01).
In the present trial, the novel RES met the prespecified criteria for noninferiority compared with ZES for the primary endpoint of target lesion failure at 12 months and had similar measures of late lumen loss. The study findings support the safety and efficacy of RES in patients representative of clinical practice, concluded the investigators in Circulation.