Author + information
- Received June 15, 2015
- Revision received September 23, 2015
- Accepted September 24, 2015
- Published online January 11, 2016.
- Ricardo A. Costa, MD, PhD∗,†∗ (, )
- Alexandre Abizaid, MD, PhD∗,†,
- Roxana Mehran, MD‡,
- Joachim Schofer, MD§,
- Gerhard C. Schuler, MD‖,
- Karl E. Hauptmann, MD¶,
- Marco A. Magalhães, MD†,
- Helen Parise, ScD‡,
- Eberhard Grube, MD#,
- BioFreedom FIM Clinical Trial Investigators
- ∗Institute Dante Pazzanese of Cardiology, São Paulo, Brazil
- †Cardiovascular Research Center, São Paulo, Brazil
- ‡Cardiovascular Research Foundation, New York, New York
- §Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany
- ‖Herzzentrum Leipzig GmbH, Leipzig, Germany
- ¶Krankenhaus der Barmherzigen Brüder, Trier, Germany
- #University of Bonn, Bonn, Germany
- ↵∗Reprint requests and correspondence:
Dr. Ricardo A. Costa, Department of Invasive Cardiology, Institute Dante Pazzanese of Cardiology/Cardiovascular Research Center, Rua Dr. Altolfo Araújo, 521–Vila Mariana, São Paulo, SP, Brazil 04012-070.
Objectives The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.
Background The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland).
Methods A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD “standard dose” (BFD) or BFD “low dose” (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany.
Results Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported.
Conclusions The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119)
- coronary artery disease
- drug-coated stent(s)
- percutaneous coronary intervention
The study was funded by Biosensors Europe SA. Dr. Costa has received speaker’s fees from Biosensors Europe SA, Medtronic, and Daiichi-Sankyo; and has served as a consultant for Biosensors Europe SA. Dr. Abizaid has received research grants from Medtronic, Boston Scientific, Abbott Vascular, Biosensors, and Elixir Medical. Dr. Mehran has received institutional research grants from Bristol-Myers Squibb/Sanofi Pharmaceuticals, Eli Lilly, AstraZeneca, The Medicines Company, and Lilly/Daiichi-Sankyo; and has received consultant/advisory board fees from Abbott Vascular, AstraZeneca, Bayer, CSL Behring, Boston Scientific, Covidien, The Medicines Company, Merck, Osprey Medical, Regado Biosciences, Sanofi-Aventis, Watermark Research Partners, and Janssen Pharmaceuticals/Johnson & Johnson. Dr. Schofer has received institutional research grants from Biosensors Europe SA. Dr. Grube has received consulting fees/honoraria from Biosensors Europe SA, Boston Scientific, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 15, 2015.
- Revision received September 23, 2015.
- Accepted September 24, 2015.
- 2016 American College of Cardiology Foundation