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

Publication ,  Conference
Marquis-Gravel, G; Boivin-Proulx, L-A; Huang, Z; Zelenkofske, SL; Lincoff, AM; Mehran, R; Steg, PG; Bode, C; Alexander, JH; Povsic, TJ
Published in: J Am Heart Assoc
January 3, 2023

Background The effectiveness of vascular closure devices (VCDs) to reduce bleeding after transfemoral percutaneous coronary intervention remains unsettled. Methods and Results Participants in the REGULATE-PCI (Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention) trial who underwent transfemoral percutaneous coronary intervention with VCD implantation were compared with those who underwent manual compression. The primary effectiveness end point was type 2, 3, or 5 Bleeding Academic Research Consortium access site bleeding at day 3. Univariate and multivariate analyses were adjusted by the inverse probability weighting method using propensity score. Time to hemostasis and time to ambulation were compared between groups. Of the 1580 patients who underwent transfemoral percutaneous coronary intervention, 1004 (63.5%) underwent VCD implantation and 576 (36.5%) had manual compression. The primary effectiveness end point occurred in 64 (6.4%) participants in the VCD group and in 38 (6.6%) participants in the manual compression group (inverse probability weighting-adjusted odds ratio, 1.02 [95% CI, 0.77-1.36]; P=0.89). There were statistically significant 2-way interactions between VCD use and female sex, chronic kidney disease, and use of high-potency P2Y12 inhibition (ticagrelor or prasugrel) (P<0.05 for all) with less bleeding with VCD use in these high-risk subgroups. Median time to hemostasis and time to ambulation were shorter in the VCD versus the manual compression group (P<0.01 for both). Conclusions Following transfemoral percutaneous coronary intervention, VCD use is associated with a shorter time to hemostasis and time to ambulation but not less bleeding. Further study of patients with high-bleeding risk is required, including women, patients with chronic kidney disease, and those using high-potency P2Y12 inhibitors. Registration URL: https://clinicaltrials.gov/ct2/show/NCT01848106; Unique identifier: NCT01848106.

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Published In

J Am Heart Assoc

DOI

EISSN

2047-9980

Publication Date

January 3, 2023

Volume

12

Issue

1

Start / End Page

e025666

Location

England

Related Subject Headings

  • Walking
  • Vascular Closure Devices
  • Treatment Outcome
  • Percutaneous Coronary Intervention
  • Humans
  • Hemostatic Techniques
  • Hemostasis
  • Hemorrhage
  • Femoral Artery
  • Female
 

Citation

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Chicago
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Marquis-Gravel, G., Boivin-Proulx, L.-A., Huang, Z., Zelenkofske, S. L., Lincoff, A. M., Mehran, R., … Povsic, T. J. (2023). Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. In J Am Heart Assoc (Vol. 12, p. e025666). England. https://doi.org/10.1161/JAHA.122.025666
Marquis-Gravel, Guillaume, Laurie-Anne Boivin-Proulx, Zhen Huang, Steven L. Zelenkofske, A Michael Lincoff, Roxana Mehran, P Gabriel Steg, Christoph Bode, John H. Alexander, and Thomas J. Povsic. “Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention.” In J Am Heart Assoc, 12:e025666, 2023. https://doi.org/10.1161/JAHA.122.025666.
Marquis-Gravel G, Boivin-Proulx L-A, Huang Z, Zelenkofske SL, Lincoff AM, Mehran R, et al. Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. In: J Am Heart Assoc. 2023. p. e025666.
Marquis-Gravel, Guillaume, et al. “Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention.J Am Heart Assoc, vol. 12, no. 1, 2023, p. e025666. Pubmed, doi:10.1161/JAHA.122.025666.
Marquis-Gravel G, Boivin-Proulx L-A, Huang Z, Zelenkofske SL, Lincoff AM, Mehran R, Steg PG, Bode C, Alexander JH, Povsic TJ. Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2023. p. e025666.
Journal cover image

Published In

J Am Heart Assoc

DOI

EISSN

2047-9980

Publication Date

January 3, 2023

Volume

12

Issue

1

Start / End Page

e025666

Location

England

Related Subject Headings

  • Walking
  • Vascular Closure Devices
  • Treatment Outcome
  • Percutaneous Coronary Intervention
  • Humans
  • Hemostatic Techniques
  • Hemostasis
  • Hemorrhage
  • Femoral Artery
  • Female