EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2014
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.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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История · было → стало
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Holm Niels R, Sindberg Birthe, Schou Mia, Maeng Michael, Kaltoft Anne, Bøttcher Morten, Krusell Lars R, Hjort Jakob, Thuesen Leif, Terkelsen Christian J, Christiansen Evald H, Bøtker Hans Erik, Kristensen Steen D, Lassen Jens F, CLOSE-UP study group
Аннотация
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 AND RESULTS: 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.
METHODS AND RESULTS: 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.