The BioNIR ridaforolimus-eluting stent was non-inferior to the Resolute zotarolimus-eluting stent for one-year clinical outcomes, according to the results of the BIONICS Trial presented Oct. 30 at TCT 2016.

David E. Kandzari, MD, FACC, et al., conducted a multi-national randomized trial assessing the safety and efficacy of the BioNIR stent compared to the Resolute stent in 1919 patients with coronary artery disease. The primary endpoint was target lesion failure at one year, the composite rate of cardiac death, target vessel myocardial infarction, and ischemia driven target lesion revascularization.

The results of the trial showed that the primary endpoint of target lesion failure was identical for both the BioNIR and Resolute stents. In addition, the rates of cardiac death (0.5 vs. 0.2 percent), target vessel myocardial infarction (3.1 vs. 3.3 percent) and ischemia driven target lesion revascularization (3.0 vs. 2.4 percent) were similar. Device success was 98.3 percent for the BioNIR stent compared to 99.5 percent for the Resolute stent.

“One-year clinical outcomes … clearly show that the [BioNIR] stent was non-inferior to the [Resolute] stent with identical target lesion failure rates,” said Kandzari. “In addition, it had a low stent thrombosis rate with no events beyond 30 days.”

Keywords: Transcatheter Cardiovascular Therapeutics, Angina, Stable, Bionics, Coronary Artery Disease, Sirolimus, Stents

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