November 7, 2016 – The large multinational randomized BIONICS study found that a novel elastic polymer coated ridaforolimus-eluting stent (Medinol’s BioNIR stent) was non-inferior to a zotarolimus-eluting stent (Medtronic’s Resolute) for one-year clinical outcomes in a broad, less selected ‘more comers’ population. Results of this trial will be submitted to the FDA for U.S. approval of this novel drug-eluting stent. 

Findings were reported at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main coronary artery (LMCA) disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. Findings from the Nordic–Baltic–British Left Main Revascularization Study (NOBLE) trial found that despite similar mortality, the five-year risk of major adverse events was higher after PCI compared to CABG for the treatment of unprotected LMCA disease.

Investigators recently unveiled clinical data from the independent BIO-RESORT study, representing the first all-comers analysis to compare the safety and efficacy of biodegradable polymer stents (BP-DES) to the durable polymer Resolute Integrity drug-eluting stent (DP-DES) from Medtronic. At one year, patients with coronary artery disease who were treated with a biodegradable polymer stent showed no clinical benefits over patients treated with Resolute Integrity.