One-Year BIONICS Data Presented for Medinol's BioNIR Ridaforolimus-Eluting Stent

October 30, 2016—The large multinational randomized BIONICS study found that the BioNIR ridaforolimus-eluting stent (Medinol, Ltd,) was noninferior to a zotarolimus-eluting stent (Resolute, Medtronic, plc) for 1-year clinical outcomes in a broad, less selected "more comers" population. The findings were reported at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The results of the trial will be submitted to the US Food and Drug Administration for approval of the device in the United States. The BIONICS trial was funded by Medinol. The trial was designed and conducted by the CRF Clinical Trials Center in collaboration with Novella Clinical, which provided site management.

The BioNIR device is a thin-strut (90 µm) cobalt chromium stent that elutes the rapamycin analogue ridaforolimus from a durable elastomeric polymeric coating. 
The multicenter randomized BIONICS trial was conducted at 76 medical centers in the United States, Canada, Europe, and Israel. The trial enrolled a broad range of patients with coronary artery disease including patients with non–ST-segment elevation myocardial infarction, as well as complex lesions.

The trial’s primary endpoint was target lesion failure (TLF) at 1 year, the composite rate of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). Secondary endpoints were 1-year major adverse cardiovascular events, target vessel failure (TVF) and individual component endpoints, definite/probable stent thrombosis, and procedural success.

As summarized in the TCT announcement, 1,919 patients were randomized 1:1 to the BioNIR ridaforolimus-eluting stent (n = 958, 1,275 lesions) or Resolute zotarolimus-eluting stent (n = 961, 1,277 lesions) stent. The baseline clinical characteristics were well balanced between the two arms, as were angiographic baseline characteristics with the exception of severe calcification (13.3% in the BioNIR group vs 10.5% in the Resolute group; P = .03).

The trial investigators found that the primary endpoint of TLF at 1 year was identical for both at 5.3% (P = .98). In addition, the rates of cardiac death (0.5% vs 0.2%; P = .29), TV-MI (3.1% vs 3.3%; P = .81) and ID-TLR (3% vs 2.4%; P = .38) were similar. Definite/probable stent thrombosis was 0.4% (4/921) for the ridaforolimus-eluting stent and 0.6% (6/927) for the zotarolimus-eluting stent (P = .75). Finally, device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent (P = .004).

Commenting on the trial in the TCT announcement, BIONICS principal investigator David E. Kandzari stated, “One-year clinical outcomes from the BIONICS study clearly show that the ridaforolimus-eluting stent was noninferior to the zotarolimus-eluting stent with identical target lesion failure rates. In addition, it had a low stent thrombosis rate with no events beyond 30 days.”