Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents in Patients with Coronary Artery Disease: Primary Results from the BIONICS Trial
Background—The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined.
Methods—A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RES) and slow-release zotarolimus-eluting stents (ZES) among 1,919 patients at 76 centers undergoing percutaneous coronary intervention. Inclusion criteria allowed enrollment of patients with recent myocardial infarction (MI), total occlusions, bifurcations lesions and other complex conditions.
Results—Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% were diabetic and 39.7% presented with acute coronary syndromes. At 12 months, the primary endpoint of target lesion failure (composite of cardiac death, target vessel-related MI and target lesion revascularization) was 5.4% for both devices (upper bound of one-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES vs. 0.6% ZES, P=0.75). 13-month angiographic in-stent late lumen loss was 0.22 ± 0.41 mm and 0.23 ± 0.39 mm (Pnoninferiority=0.004) for the RES and ZES groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10 ± 5.81 and 8.85 ± 7.77, respectively (Pnoninferiority=0.01).
Conclusions—In the present trial which allowed broad inclusion criteria, 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. These findings support the safety and efficacy of RES in patients representative of clinical practice.
Clinical Trial Registration—URL: www.ClinicalTrials.gov Unique Identifier: NCT01995487
- Received April 10, 2017.
- Revision received June 26, 2017.
- Accepted July 20, 2017.