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
Niels R Holm, Birthe Sindberg, Mia Schou, Michael Maeng, Anne Kaltoft, Morten Bøttcher, Lars R Krusell, Jakob Hjort, Leif Thuesen, Christian J Terkelsen, Evald H Christiansen, Hans Erik Bøtker, Steen D Kristensen, Jens F Lassen, CLOSE-UP study group, Niels R Holm, Birthe Sindberg, Mia Schou, Michael Maeng, Anne Kaltoft, Morten Bøttcher, Lars R Krusell, Jakob Hjort, Leif Thuesen, Christian J Terkelsen, Evald H Christiansen, Hans Erik Bøtker, Steen D Kristensen, Jens F Lassen, CLOSE-UP study group
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 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.
Trial registration: ClinicalTrials.gov NCT01001663.
Source: PubMed