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

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

doi:10.4244/EIJ-D-20-01162

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

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

Department of Cardiology

3 Citations (Scopus)

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.

Original language	English
Journal	EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Volume	17
Issue number	3
Pages (from-to)	233-239
Number of pages	7
ISSN	1774-024X
DOIs	https://doi.org/10.4244/EIJ-D-20-01162
Publication status	Published - 25 Jun 2021

Keywords

Absorbable Implants
Aged
Drug-Eluting Stents
Female
Humans
Percutaneous Coronary Intervention/adverse effects
Polymers
Prospective Studies
Prosthesis Design
Sirolimus/therapeutic use
Spain
Stents
Treatment Outcome
Drug-eluting stent
Clinical trials
QCA

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Sabaté, M., Okkels Jensen, L., Tilsted, H-H., Moreno, R., García Del Blanco, B., Macaya, C., Pérez de Prado, A., Cequier, À., Pérez-Fuentes, P., Schütte, D., Costa, R. A., Stoll, H-P., & Flensted Lassen, J. (2021). Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 17(3), 233-239. https://doi.org/10.4244/EIJ-D-20-01162

Thin- versus thick-strut polymer-free biolimus-eluting stents : the BioFreedom QCA randomised trial. / Sabaté, Manel; Okkels Jensen, Lisette; Tilsted, Hans-Henrik et al.

In: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Vol. 17, No. 3, 25.06.2021, p. 233-239.

Research output: Contribution to journal › Journal article › Research › peer-review

Sabaté, M, Okkels Jensen, L, Tilsted, H-H, Moreno, R, García Del Blanco, B, Macaya, C, Pérez de Prado, A, Cequier, À, Pérez-Fuentes, P, Schütte, D, Costa, RA, Stoll, H-P & Flensted Lassen, J 2021, 'Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial', EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, vol. 17, no. 3, pp. 233-239. https://doi.org/10.4244/EIJ-D-20-01162

Sabaté M, Okkels Jensen L, Tilsted H-H, Moreno R, García Del Blanco B, Macaya C et al. Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2021 Jun 25;17(3):233-239. https://doi.org/10.4244/EIJ-D-20-01162

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title = "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.",

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author = "Manel Sabat{\'e} and {Okkels Jensen}, Lisette and Hans-Henrik Tilsted and Ra{\'u}l Moreno and {Garc{\'i}a Del Blanco}, Bruno and Carlos Macaya and {P{\'e}rez de Prado}, Armando and {\`A}ngel Cequier and Pedro P{\'e}rez-Fuentes and Diana Sch{\"u}tte and Costa, {Ricardo A} and Hans-Peter Stoll and {Flensted Lassen}, Jens",

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doi = "10.4244/EIJ-D-20-01162",

language = "English",

volume = "17",

pages = "233--239",

journal = "EuroIntervention",

issn = "1774-024X",

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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

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DO - 10.4244/EIJ-D-20-01162

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JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 3

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

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