TY - JOUR JO - EuroIntervention TI - Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial AB - <p><strong>Background:</strong> 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.</p> <p><strong>Aims:</strong> 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).</p> <p><strong>Methods:</strong> 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.</p> <p><strong>Results:</strong> 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&plusmn;0.49 mm in the BF-CoCr group versus 0.29&plusmn;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).</p> <p><strong>Conclusions:</strong> 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.</p> AU - Sabaté Manel AU - Jensen Okkels Lisette AU - Tilsted Hans-Henrik AU - Moreno Raul AU - García Del Blanco Bruno AU - Macaya Carlos AU - Perez de Prado Armando AU - Cequier Angel AU - Pérez-Fuentes Pedro AU - Schütte Diana AU - Costa A. Ricardo AU - Stoll Hans-Peter AU - Lassen Jens Flensted VL - 17 IS - 3 Y1 - 25/06/2021 Y1 - 2021 DOI - 10.4244/EIJ-D-20-01162 SP - 233 EP - 239 KW - clinical trials KW - drug-eluting stent KW - qca PB - Europa Digital & Publishing SE - Coronary interventions - Mini focus on drug-eluting stents UR - https://eurointervention.pcronline.com/article/efficacy-of-thin-versus-thick-strut-polymer-free-biolimus-eluting-stents-the-biofreedom-qca-randomized-trial SN - 1774-024X ER -