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Region Hovedstaden - en del af Københavns Universitetshospital
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Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Manel Sabaté
  • Lisette Okkels Jensen
  • Hans-Henrik Tilsted
  • Raúl Moreno
  • Bruno García Del Blanco
  • Carlos Macaya
  • Armando Pérez de Prado
  • Àngel Cequier
  • Pedro Pérez-Fuentes
  • Diana Schütte
  • Ricardo A Costa
  • Hans-Peter Stoll
  • Jens Flensted Lassen
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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.

OriginalsprogEngelsk
TidsskriftEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Vol/bind17
Udgave nummer3
Sider (fra-til)233-239
Antal sider7
ISSN1774-024X
DOI
StatusUdgivet - 25 jun. 2021

ID: 62372698