title: 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.
abstract: OBJECTIVE
  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).
  
  
  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.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.
authors.forename: Niels R
authors.initials: NR
authors.lastname: Holm
authors.forename: Birthe
authors.initials: B
authors.lastname: Sindberg
authors.forename: Mia
authors.initials: M
authors.lastname: Schou
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.forename: Morten
authors.initials: M
authors.lastname: Bøttcher
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.forename: Jakob
authors.initials: J
authors.lastname: Hjort
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Terkelsen
authors.forename: Evald H
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Hans Erik
authors.initials: HE
authors.lastname: Bøtker
authors.forename: Steen D
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D017023:Coronary Angiography / Q000009:adverse effects / Q000379:methods*; D003718:Denmark; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006406:Hematoma / Q000209:etiology / Q000517:prevention & control; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011312:Pressure; D011677:Punctures; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices