Randomised comparison of manual compression and FemoSeal™ vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study.
EuroIntervention
; 10(2): 183-90, 2014 Jun.
Article
em En
| MEDLINE
| ID: mdl-24603054
ABSTRACT
AIMS:
To compare in a randomised trial the safety and efficacy of the FemoSeal vascular closure device (VCD) versus manual compression (MC) after femoral access coronary angiography (CAG). METHODS ANDRESULTS:
In 13 months, 1,014 patients were included and 1,001 patients entered analysis. Median [interquartile range] closure time was 8.0 [6-10] minutes after MC versus 1.0 [1-1] minute (p<0.0001) for the FemoSeal VCD. Bed rest for one hour after the closure procedure was recommended in both groups. The primary endpoint of incidence of large groin haematoma was 6.7% in the MC group vs. 2.2% (p=0.002) in the FemoSeal group. The combined endpoint of 14-day adverse vascular events occurred in 1.0% in the MC group vs. 0.6% in the FemoSeal VCD group (p=0.7). Manual compression (OR 3.3, 95% CI 1.5-7.2, p=0.002), female gender (OR 2.1, 95% CI 1.1-3.9, p=0.018), and multiple punctures (OR 10.5, 95% CI 3.2-34.3, p=0.001) were identified as independent predictors of adverse events and large haematomas.CONCLUSIONS:
Closure of femoral access after coronary angiography by the FemoSeal vascular closure device was safe, faster, and associated with significantly fewer in-hospital large haematomas as compared to closure by manual compression.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Técnicas Hemostáticas
/
Angiografia Coronária
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Artéria Femoral
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Dispositivos de Oclusão Vascular
/
Hemorragia
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
EuroIntervention
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Dinamarca