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

Abstract

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.

Conflict of interest statement

M. Sabaté has received consultant fees from Abbott Vascular and iVascular outside the submitted work. A. Perez de Prado has received consultant fees from B. Braun, Boston Scientific and iVascular outside the submitted work. A. Cequier has received consultant fees from Abbott Vascular, Biotronik and Medtronic outside the submitted work. J. Flensted Lassen has received consultant fees from Abbott Vascular, Boston Scientific and Medtronic outside the submitted work. D. Schütte and H.-P. Stoll are employees of Biosensors. The other authors have no conflicts of interest to declare.

Figures

Figure 1

Study flow chart.

Figure 2

Cumulative distribution curves of the LLL between the BF-CoCr and BF-SS groups. LLL: late lumen loss