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

DOI: 10.4244/EIJ-D-20-01162

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)

As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention and external reviewers - has been published immediately upon acceptance as it was received in the last round of revision. The content of this article is the responsibility of the authors.

Please note that supplementary movies are not available online at this stage. Once a paper is published in its edited and formatted form, it will be accompanied online by any supplementary movies.

To read the full content of this article, please log in to download the PDF.

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.

Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from

Read next article
Performing elective cardiac invasive procedures during the COVID-19 outbreak: a position statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI)