Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study

Abstract

Background: Pain and discomfort in relation to vascular closure are the predominant patient complaints after coronary angiography (CAG). No large-scale randomized studies have evaluated pain and discomfort after CAG with access site closure by manual compression versus a vascular closure device (VCD).

Aim: To compare pain and discomfort after femoral artery closure by manual compression versus FemoSeal® VCD.

Methods: The study is a sub study to the CLOSE-UP study, a randomized, single centre comparison of FemoSeal(®) VCD versus manual compression after CAG. Pain and discomfort score was assessed immediately after the closure procedure, at time for mobilization, at discharge and after 14 days.

Results: 1014 patients were included and 1001 patients entered analysis. In-hospital follow-up was obtained for all patients and 14-day follow-up was completed for 96% of patients. The closure procedure lasted 1 (1-1) min in the FemoSeal(®)VCD group and 8 (6-10) min in the manual compression group. Pain and discomfort score at the procedure was significantly higher in the FemoSeal(®)VCD group. No differences in pain and discomfort were detected after leaving the catheterization laboratory.

Conclusion: Closure of femoral access after CAG by the FemoSeal(®)VCD was associated with significantly more pain and discomfort compared with closure by manual compression. No difference in pain and discomfort was found at follow-up.

Trial registration: ClinicalTrials.gov NCT01001663.

Keywords: Manual compression; bleeding; coronary; coronary angiography; pain; vascular closure device.