A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general

R A Veasey1, J K Large, J Silberbauer

  • 1Cardiac Department, Eastbourne District General Hospital, King's Drive, Eastbourne, UK.

Insights

StarClose and AngioSeal vascular closure devices (VCDs) offer similar haemostasis after cardiac catheterisation. StarClose resulted in less bruising at one week, with comparable complication rates and patient satisfaction.

Area of Science:

  • Cardiology
  • Vascular Surgery
  • Medical Devices

Background:

  • Vascular closure devices (VCDs) like AngioSeal and StarClose facilitate haemostasis after femoral artery procedures.
  • These devices offer advantages over manual pressure, reducing time to haemostasis and ambulation.

Purpose of the Study:

  • To compare the efficacy and safety of AngioSeal VIP and StarClose VCDs in patients undergoing elective coronary angiography.
  • To evaluate post-procedure bruising, patient satisfaction, and complication rates between the two VCDs.

Main Methods:

  • A prospective, randomized trial involving 401 patients undergoing elective coronary angiography.
  • Patients received either AngioSeal VIP or StarClose VCD, followed by immediate mobilization.
  • Bruising, patient satisfaction, pain perception, and complications were assessed at various time points.

Main Results:

  • Arteriotomy closure success rates were similar between AngioSeal (69.2%) and StarClose (69.3%).
  • No significant bruising was observed at 30 or 60 minutes post-procedure.
  • Significantly less bruising occurred at 1 week with StarClose (38.5 cm²) compared to AngioSeal (63.1 cm²; p=0.02).
  • Patient satisfaction and pain perception were comparable between groups.
  • Deployment success and mobilization rates were lower for junior operators.

Conclusions:

  • Both AngioSeal and StarClose achieve similar haemostasis following cardiac catheterisation.
  • StarClose demonstrates a significant reduction in bruising at one week compared to AngioSeal.
  • No significant differences in complication rates, patient satisfaction, or pain perception were found between the two devices.
Abstract

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