BIONICS: Ridaforolimus-Eluting Stent Noninferior to Zotarolimus Stent at 1 Year

In a broad population of patients with complex CAD undergoing PCI, the BioNIR ridaforolimus-eluting stent (RES) was noninferior to the Resolute zotarolimus-eluting stent (ZES) for TLF at 1 year, and its use resulted in low rates of stent thrombosis and TLR.

The primary outcome of TLF at 1 year was 5.3% among patients randomized to the BioNIR RES (Medinol, Tel Aviv, Israel) or Resolute ZES (Medtronic). This event rate met the prespecified noninferiority margin, with a P value of 0.0012.

David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA), reported the BIONICS results today in the Main Arena at TCT 2016.

Individual components of the primary outcome at 1 year were also similar between the BioNIR and Resolute arms: cardiac death, 0.5% vs 0.2% (P = 0.29), target vessel MI (3.1% vs 3.3%; P = 0.81) and ischemia-driven TLR (3% vs 2.4%; P = 0.38).

Discussing the new data during the late-breaking clinical trial presentation, Gregg W. Stone, MD (NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY), said BIONICS “is a very interesting study, and important, because it has been some time since we’ve had a new metallic DES in the United States and this trial was designed to overcome that limitation.”

Safety, Efficacy Demonstrated

The BIONICS trial enrolled a more-comers population with symptomatic CAD and complex lesions at 76 centers in eight countries. A total of 1,919 patients were randomized 1:1 to receive the BioNIR RES (n = 958, 1,275 lesions) or Resolute ZES (n = 961; 1,277 lesions). Baseline and angiographic characteristics were well balanced, with the exception of more severe calcification in the RES arm (13.3% vs 10.5%; P = 0.03). Procedural success was greater than 97% in both arms.

Stent thrombosis was “very low” in this trial, Kandzari said. The rate of definite or probable stent thrombosis was 0.4% with BioNIR RES and 0.6% with Resolute ZES (P = 0.75).

Moreover, in prespecified subgroup analyses, TLF at 1 year was not significantly different based on presence of ACS or diabetes, sex, age or region.

“These findings endorse the safety and efficacy of BioNIR in patients who are representative of real-world clinical practice,” Kandzari said during the late-breaking clinical trials session.

Future Directions

The BioNIR RES is a thin-strut (90 µm) cobalt chromium stent that elutes ridaforolimus from a durable elastomeric polymeric coating. More than 95% of the drug is eluted from the stent in a low and stable concentration over an approximate 180-day period, according to Kandzari.

Looking ahead, a subgroup of patients enrolled in BIONICS are undergoing angiographic and IVUS follow-up at 13 months.

Results of the BIONICS trial fall against the background of the simultaneously initiated NIREUS trial (n = 302). Findings presented at EuroPCR 2016 demonstrated noninferiority of BioNIR versus Resolute for 6-month in-stent late loss (P < 0.0001) and showed similar clinical outcomes between the two arms.