Coronary interventions - Mini focus on drug-eluting stents

Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial

EuroIntervention 2021;17:233-239. DOI: 10.4244/EIJ-D-20-01162

Manel Sabaté
Manel Sabaté1, MD, PhD; Lisette Okkels Jensen2, MD, PhD; Hans-Henrik Tilsted3, MD, PhD; Raúl Moreno4, MD; Bruno García del Blanco5, MD, PhD; Carlos Macaya6, MD, PhD; Armando Pérez de Prado7, MD, PhD; Angel Cequier8, MD, PhD; Pedro Pérez-Fuentes1, MD; Diana Schütte9, PhD; Ricardo A. Costa10, MD; Hans-Peter Stoll9, MD; Jens Flensted Lassen2,3, MD, PhD
1. Department of Interventional Cardiology, Cardiovascular Institute, Hospital Clinic IDIBAPS, Barcelona, Spain; 2. Odense University Hospital, Odense, Denmark; 3. Department of Cardiology, Rigshospitalet, University of Copenhagen, 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. Biosensors Europe, S.A., Morges, Switzerland; 10. HCor, Associaçao Beneficente Siria, Sao Paolo, Brasil

Background: The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy.

Aims: The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI).

Methods: This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year.

Results: A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the 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 nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.

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clinical trialsdrug-eluting stentqca
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