Biofreedom tct10 press final

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Biofreedom tct10 press final

  1. 1. BioFreedom: A Prospective Randomized Trial of Polymer-Free Biolimus A9-Eluting Stents and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease Eberhard Grube, MD, FACC, FSCAI on behalf of the BioFreedom Investigators International Heart Center Essen, GermanyHospital A Oswaldo Cruz, Instituto Dante Pazzanese, São Paulo, Brazil Stanford University, School of Medicine, Stanford, CA
  2. 2. BioFreedom™Selectively micro-structured surface holds drug in abluminal surface structures Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings. Potential advantage • Avoid long term late adverse effects that might be Proprietary Highly Lipophilic Limus drug attributable to the polymer • Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts • Possible shorter need of dual antiplatelet therapy
  3. 3. BioFreedom FIM Design BioFreedom FIM 182 patients First Cohort Second Cohort 12 Month Clinical FU 99% 4 Month Angio FU 12 Month Angio FU 75 patients 107 patients Angio FU 92% Angio FU 92%BioFreedom BioFreedom BioFreedom BioFreedom standard low TAXUS® standard low TAXUS® dose dose Liberté ® dose dose Liberté ® (BFD SD) (BFD LD) N=24 (BFD SD) (BFD LD) N=36 N=25 N=26 N=35 N=36 Enrollment Period Enrollment Period Sept 2008 – Jan 2009 Jan 2009 – Jun 2009
  4. 4. BioFreedom FIM Study Design Symptomatic, ischemic heart disease Native coronary artery ≥ 2.25 mm and ≤ 3.0 mm Lesion length ≤ 14 mm Lesion amenable to percutaneous treatment with DES BioFreedom™ BioFreedom™ Taxus® Liberté®Standard Dose 15.6 µg/mm Low Dose 7.8 µg/mmClinical Follow-Up 30 d 4 mo 12 mo 2yr 3yr 4yr 5yrAngio and IVUS Follow-upPrimary Endpoint: In-stent Late Lumen Loss (LL) at 12 months (2nd cohort) Non-Inferiority, margin = 0.24 mmSecondary Endpoints: In-stent Late Lumen Loss (LL) at 4 months (1st cohort) MACE and stent thrombosis rate at 30 days, 4, 12 months, 2, 3, 4 & 5 yrs Clinically-driven TLR, TVR and TVF at 4, 12 months, 2, 3, 4 & 5 yrs In-stent/In-segment binary restenosis at 4 months In-stent/In-segment Minimum Lumen Diameter (MLD) at 4 months Neointimal hyperplasia volume at 4 months measured by IVUS Biolimus A9 concentrations pre/post procedure at discharge & 30 daysDAPT recommended for a minimum of 6 months
  5. 5. 12 Month Angiographic FU In-Stent Late Lumen Loss: 2nd Cohort Primary Endpoint Non – inferiority P = 0.001 P values 0.4 P = 0.21 0.35 [0.22, 0.57] 0.3 0.22 [0.17, 0.66] 0.17(mm) 0.2 [0.09, 0.39] 0.1 0.0 BFD SD BFD LD Taxus N = 31 N = 35 N = 31 All values are presented as median [IQR] .
  6. 6. 12 Month Angiographic FU In-Stent Late Lumen Loss: 2nd Cohort Primary Endpoint Superiority P values P = 0.11 0.4 P = 0.55 0.35 0.3 0.22(mm) 0.2 0.17 0.1 0.0 BFD SD BFD LD Taxus N = 31 N = 35 N = 31 All values are presented as median.
  7. 7. 12 Month MACE (KM Estimates) All Patients (1st + 2nd Cohorts) BFD SD BFD LD Taxus N = 60 N = 62 N = 60MACE* 3 (6.1%) 7 (11.6%) 3 (5.5%)(All Death, MI, Emergent Bypass or TLR) All Death 1 (1.8%) 0 (0.0%) 0 (0.0%) MI 1 (1.8%) 1 (1.6%) 0 (0.0%) Q Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) Non-Q Wave MI 1 (1.8%) 1 (1.6%)** 0 (0.0%) Emergent Bypass 0 (0.0%) 0 (0.0%) 0 (0.0%) TLR 1 (1.8%) 6 (10.0%) 3 (5.5%)*Time to first event**In-hospital MI All p values are non significant. Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
  8. 8. 12 Month Stent Thrombosis All Patients (1st + 2nd Cohorts) BFD SD BFD SD Taxus N = 60 N = 62 N = 60 Acute (%) 0 0 0 Sub-acute (%) 0 0 0 Late (%) 0 0 0Possible, probable or definite stent thrombosis as per ARC Definition. All P values are non significant. Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.
  9. 9. Summary & Conclusions - 1• Primary endpoint (In-Stent LL at 12 months) met: BioFreedom SD non-inferior to Taxus.• In-Stent LL for BioFreedom SD (0.17 mm) demonstrated a trend towards superiority at 12 months compared to Taxus (0.35 mm).• Both BioFreedom SD and BioFreedom LD demonstrated sustained safety up to 12 months, including absence of stent thrombosis.
  10. 10. Summary & Conclusions - 2• BioFreedom: first polymer-free drug coated stent demonstrating comparable efficacy in inhibiting NIH (as assessed by independent QCA analysis) vs. a currently available DES with durable polymer at 12 months in a randomized clinical trial.• Larger trial with longer term follow-up warranted to confirm these encouraging results.

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