The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Efficacy of Thin- Versus Thick-Strut Polymer-Free Biolimus-Eluting Stents: the Biofreedom QCA Randomized Trial
Manel Sabate1; Lisette Okkels-Jensen2; Hans-Henrik Tilsted3; Raul Moreno4; Bruno García del Blanco5; Carlos Macaya6; Armando Pérez de Prado7; Angel Cequier8; Pedro Pérez-Fuentes9; Diana Schütte10; Ricardo Costa11; Hans-Peter Stoll10; Jens Flensted Lassen12;
1. Interventional Cardiology Department; Cardiovascular Institute; Hospital Clinic IDIBAPS (Barcelona, Spain), Spain 2. Odense University Hospital (Odense, Denmark) 3. Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (Copenhagen; Denmark) 4. Hospital Universitario de la Paz (Madrid, Spain) 5. Hospital Universitario Valle de Hebrón,CIBER CV (Barcelona, Spain) 6. Hospital Clínico San Carlos (Madrid, Spain) 7. Hospital Universitario de León (León, Spain) 8. Bellvitge University Hospital, University of Barcelona, IDIBELL. (Barcelona, Spain) 9. Interventional Cardiology Department; Cardiovascular Institute; Hospital Clínic; IDIBAPS (Barcelona, Spain) 10. Biosensors Europe, S.A. (Morges, Switzerland) 11. HCor, Associaçao Beneficente Siria (Sao Paolo, Brasil) 12. Odense University Hospital (Odense, Denmark);Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (Copenhagen; Denmark)
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Aims: To evaluate the efficacy of the new BioFreedom Ultra™ drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BioFreedom™ drug-coated stent with a stainless-steel platform (BF-SS) in an all-comers population undergoing percutaneous coronary interventions (PCI).
Methods and results: This was a prospective, multi-center, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiographic at 9-month follow-up. Clinical evaluation was performed at 1 year. A total of 200 patients were randomized (1:1) to either the BF-CoCr or the BF-SS stent at 8 centers in Spain and Denmark. Baseline clinical and lesion characteristics were similar among the groups. Mean age was 66 years and 23% were females. The mean number of stents implanted per patient was 1.5. At 9-month follow-up, mean in-stent LLL was 0.34±0.49mm in BF-CoCr versus 0.29±0.37mm in the BF-SS, p=0.005 for non-inferiority. At 1-year, target lesion failure was similar between groups (7.3% in Bf-CoCr vs 9.3% in the BF-SS group; p=0.60).
Conclusions: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at 9 months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.