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Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary

Guillaume Marquis-Gravel1,2, Laurie-Anne Boivin-Proulx2, Zhen Huang1

  • 1Duke Health Duke Clinical Research Institute and Duke University Durham NC.

Journal of the American Heart Association
|December 30, 2022
PubMed

Insights

Vascular closure devices (VCDs) shorten time to hemostasis and ambulation after transfemoral percutaneous coronary intervention but do not reduce bleeding events. High-risk subgroups may benefit from VCDs, warranting further investigation.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Vascular Surgery

Background:

  • Transfemoral percutaneous coronary intervention (PCI) is a common procedure.
  • Vascular closure devices (VCDs) are used to achieve hemostasis after PCI.
  • The effectiveness of VCDs in reducing bleeding complications remains debated.

Purpose of the Study:

  • To compare the effectiveness of VCDs versus manual compression in reducing access site bleeding after transfemoral PCI.
  • To evaluate time to hemostasis and time to ambulation in patients undergoing transfemoral PCI with VCDs or manual compression.

Main Methods:

  • Analysis of participants from the REGULATE-PCI trial who underwent transfemoral PCI.
  • Comparison of patients who received VCD implantation versus manual compression.
  • Primary endpoint: Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 access site bleeding at day 3.
  • Propensity score-based inverse probability weighting for adjusted analyses.

Main Results:

  • No significant difference in the primary bleeding endpoint between VCD and manual compression groups (6.4% vs. 6.6%).
  • VCD use was associated with significantly shorter median time to hemostasis and time to ambulation.
  • Significant interactions observed: VCDs showed reduced bleeding in subgroups of women, patients with chronic kidney disease, and those on high-potency P2Y12 inhibitors.

Conclusions:

  • VCDs facilitate faster hemostasis and ambulation post-transfemoral PCI but do not decrease overall bleeding rates.
  • Further research is needed for high-bleeding risk populations, including women, CKD patients, and those on potent P2Y12 inhibitors.

Keywords:
arterial accessbleedingoutcomespercutaneous coronary interventionradial

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