BioFreedom FIM: Noninferiority of Novel Polymer-Free Stent
The BioFreedom polymer/carrier free Biolimus-coated stent proved non-inferior to paclitaxel-eluting stents in patients with de novo coronary lesions, according to the results of a study presented Oct. 11 at TCT 2015 and simultaneously published in JACC: Cardiovascular Interventions.
Researchers evaluated the efficacy and long-term outcomes of the BioFreedom drug-coated stent through a randomized trial of 182 patients with de novo coronary lesions. Patients received either the BioFreedom standard dose drug-coated stent, a low-dose version or a first-generation paclitaxel-eluting stent.
According to the results of the study, in-stent late lumen loss was lower with the BioFreedom standard dose versus the paclitaxel-eluting stent at 12 month follow-up. Although the BioFreedom low dose drug-eluting stent did not reach non-inferiority, there were no significant differences amongst the three stents in major adverse cardiac events at five-year follow-up.
“Non-polymer based drug-eluting stents could offer, at least theoretically, additional advantages [over durable polymers in first-generation drug-eluting stents],” state Ricardo A. Costa, MD, PhD, et al. These benefits include “optimize[d] vascular healing, maintain[ed] stent surface integrity, and shorten[ed] dual antiplatelet therapy post-stent implantation.”
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