Very Long-term Results of BioFreedom First-In-Man, a Randomized Trial comparing Polymer-Free BioFreedom™ stents with Durable Polymer Taxus Liberte™ Stents

Background: US guidelines currently recommend 12 months of uninterrupted DAPT after implantation of DES. Prolonged and more powerful DAPT regimens have offered benefit by reducing VLST, but at the cost of increased risk of bleeding. There is an emerging need for new stents that are less dependent on prolonged DAPT. The BioFreedom®stent (BFD) releases Biolimus A9®, without using a polymer or binder. Based on an animal model, 98% of the drug diffuses to the vessel wall within 1 month, leaving a BMS in place. It is reasonable therefore to consider that the stent offers a potential safety advantage and a reduced need for prolonged DAPT compared to a polymer based DES. This First-In-Man trial aims to demonstrate the safety and effectiveness of theBFDcompared to the Taxus Liberté®paclitaxel-eluting stent (PES). Methods: The BioFreedom FIM is a prospective, multi-center, randomized trial. 182 patients were enrolled and randomized to BFD Standard Dose (SD, 15.6 mg/mm), or BFD Low Dose (LD, 7.8 mg/mm), or Taxus Liberté® DES. The primary endpoint was in-stent Late Loss (LL) at 12 months. The main secondary endpoints are IVUS neointimal volume at 4 & 12 months; MACE (death, MI, emergent bypass or clinically-driven TLR) and ST rates (ARC defined) at 30 days, 4 and 12 months, and then yearly up to 5 years. Results: The in-stent LL was non inferior in BFD SD (p non-inferiority = 0.001) and trended towards superiority with medians of 0.17mm [0.09, 0.39] vs. 0.35mm [0.22, 0.57] compared to PES (p sup=0.11) at 12 months. At 3 years, the clinical FU was 96%. The BFD SD and PES showed similar rates of MACE (BFD SD 11.9% vs. PES 10.0%) with no definite/probable ST in any group. Interestingly, at 2 years, there was a significant difference in adherence to DAPT between the groups (BFD SD 5.2% vs. PES 19% p=0.025) which disappeared at 3 years. Conclusions: The safety and efficacy of the polymer free BioFreedom has been shown out to 3 years. An ongoing trial is studying the possibility of using this stent in patients with high bleeding risk, unable to tolerate a prolonged course of DAPT. The BioFreedom FIM 4-year follow-up will be reported for the 1st time during this presentation.