Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.
EuroIntervention
; 20(13): e806-e817, 2024 Jul 01.
Article
en En
| MEDLINE
| ID: mdl-38742581
ABSTRACT
BACKGROUND:
The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.AIMS:
The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).METHODS:
This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.RESULTS:
A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI] -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI -0.94 to 0.76) mm2; p=non-significant.CONCLUSIONS:
This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov NCT04733443).
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Angioplastia Coronaria con Balón
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Paclitaxel
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Sirolimus
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Reestenosis Coronaria
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Stents Liberadores de Fármacos
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Intervención Coronaria Percutánea
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
EuroIntervention
Asunto de la revista:
ANGIOLOGIA
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CARDIOLOGIA
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TERAPEUTICA
Año:
2024
Tipo del documento:
Article
País de afiliación:
China