TY - JOUR
T1 - Thin- versus thick-strut polymer-free biolimus-eluting stents
T2 - the BioFreedom QCA randomised trial
AU - Sabaté, Manel
AU - Okkels Jensen, Lisette
AU - Tilsted, Hans-Henrik
AU - Moreno, Raúl
AU - García Del Blanco, Bruno
AU - Macaya, Carlos
AU - Pérez de Prado, Armando
AU - Cequier, Àngel
AU - Pérez-Fuentes, Pedro
AU - Schütte, Diana
AU - Costa, Ricardo A
AU - Stoll, Hans-Peter
AU - Flensted Lassen, Jens
PY - 2021/6/25
Y1 - 2021/6/25
N2 - 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.
AB - 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.
KW - Absorbable Implants
KW - Aged
KW - Drug-Eluting Stents
KW - Female
KW - Humans
KW - Percutaneous Coronary Intervention/adverse effects
KW - Polymers
KW - Prospective Studies
KW - Prosthesis Design
KW - Sirolimus/therapeutic use
KW - Spain
KW - Stents
KW - Treatment Outcome
KW - Drug-eluting stent
KW - Clinical trials
KW - QCA
UR - http://www.scopus.com/inward/record.url?scp=85109712957&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-20-01162
DO - 10.4244/EIJ-D-20-01162
M3 - Journal article
C2 - 33433389
SN - 1774-024X
VL - 17
SP - 233
EP - 239
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 3
ER -