A prospective randomized trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: 6 months angiographic and 1 year clinical results of the NIREUS trial.

AIMS: To evaluate the efficacy and safety of the BioNIR stent compared with the Resolute stent for the treatment of coronary artery disease.

METHODS AND RESULTS: This first-in-human, multicenter, single-blind randomized non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes (ACS) were randomly assigned to treatment with BioNIR or Resolute stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at 6 months. 302 patients were randomized, of whom 84 (27.8%) were diabetic and 91 (30.1%) presented with ACS. 261 (86.0%) patients underwent 6-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute stent for the primary endpoint of in-stent LLL at 6 months (0.04 ± 0.30 mm vs. 0.03 ± 0.31 mm respectively, P non inferiority <0.0001). At 12-months follow-up, target lesion failure occurred in 3.4% in the ridaforolimus group and 5.9% in the zotarolimus group (P =0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs 5.9%, respectively, P=0.45).

CONCLUSIONS: The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at 6 months. Clinical outcomes at one year were comparable between the two groups.