TY - JOUR
T1 - Randomised comparison of manual compression and FemoSeal™ vascular closure device for closure after femoral artery access coronary angiography
T2 - The CLOSure dEvices Used in everyday Practice (CLOSE-UP) study
AU - Holm, Niels R.
AU - Sindberg, Birthe
AU - Schou, Mia
AU - Maeng, Michael
AU - Kaltoft, Anne
AU - Bøttcher, Morten
AU - Krusell, Lars R.
AU - Hjort, Jakob
AU - Thuesen, Leif
AU - Terkelsen, Christian J.
AU - Christiansen, Evald H.
AU - Bøtker, Hans Erik
AU - Kristensen, Steen D.
AU - Lassen, Jens F.
PY - 2014/6
Y1 - 2014/6
N2 - 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.
AB - 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.
KW - Closure device
KW - Coronary angiography
KW - Manual compression
UR - http://www.scopus.com/inward/record.url?scp=84905493557&partnerID=8YFLogxK
U2 - 10.4244/EIJV10I2A31
DO - 10.4244/EIJV10I2A31
M3 - Journal article
C2 - 24603054
AN - SCOPUS:84905493557
SN - 1774-024X
VL - 10
SP - 183
EP - 190
JO - EuroIntervention
JF - EuroIntervention
IS - 2
ER -