Two-Year BIONICS Data Presented for Medinol's EluNIR Stent
March 6, 2018—The EluNIR ridaforolimus-eluting coronary stent system (Medinol Ltd.; distributed by Cordis, a Cardinal Health company) continued to show comparable results to the Resolute zotarolimus-eluting stent (Medtronic) at 2-year follow-up, according to results presented at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.
In the BIONICS trial, 1,919 patients with symptomatic coronary artery disease were randomized 1:1 to treatment with EluNIR or Resolute. The study was led by David E. Kandzari, MD, Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute in Atlanta, Georgia.
As summarized by CRT, for the primary endpoint of the 12-month rate of target lesion failure (TLF), EluNIR showed noninferiority to Resolute (5.4% vs 5.4%; hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.75–1.46; Pnoninferiority = .001). The results at 24 months continued to be similar, with TLF rates of 7.6% for EluNIR versus 7.2% for Resolute (HR, 1.05; 95% CI, 0.75–1.46). TLF was defined as a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization.
The investigators also reported that both the EluNIR and Resolute devices showed low rates of stent thrombosis at 24 months. Of particular note, EluNIR demonstrated a very low 0.1% rate of stent thrombosis after 30 days compared to 0.5% for Resolute (HR, 0.56; 95% CI, 0.19 to 1.67; P = 0.1).
The BIONICS investigators noted that the 24-month follow-up rate was > 99% in both groups. The study will continue to follow patients up to 5 years.
Commenting on the study and its findings with Cardiac Interventions Today, Dr. Kandzari stated, "Overall, these favorable outcomes observed with the EluNIR stent in a more complex patient and lesion population endorse the safety and efficacy of this stent in patients representative of those routinely encountered in clinical practice. The efficacy and safety data through 2 years provide the opportunity for further study in potential indications that could include complex lesion anatomy or even abbreviated dual antiplatelet therapy."