Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention
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 percutaneou...
| Auteurs principaux: | , , , , , , , , , |
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| Format: | Article |
| Langue: | English |
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Wiley
2023-01-01
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| Collection: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Sujets: | |
| Accès en ligne: | https://www.ahajournals.org/doi/10.1161/JAHA.122.025666 |
| _version_ | 1828014332806430720 |
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| author | Guillaume Marquis‐Gravel Laurie‐Anne Boivin‐Proulx Zhen Huang Steven L. Zelenkofske A. Michael Lincoff Roxana Mehran P. Gabriel Steg Christoph Bode John H. Alexander Thomas J. Povsic |
| author_facet | Guillaume Marquis‐Gravel Laurie‐Anne Boivin‐Proulx Zhen Huang Steven L. Zelenkofske A. Michael Lincoff Roxana Mehran P. Gabriel Steg Christoph Bode John H. Alexander Thomas J. Povsic |
| author_sort | Guillaume Marquis‐Gravel |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T09:59:19Z |
| format | Article |
| id | doaj.art-d669204f901b4410a902da5fb7cf5d6c |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-10T09:59:19Z |
| publishDate | 2023-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-d669204f901b4410a902da5fb7cf5d6c2023-02-16T10:55:33ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802023-01-0112110.1161/JAHA.122.025666Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary InterventionGuillaume Marquis‐Gravel0Laurie‐Anne Boivin‐Proulx1Zhen Huang2Steven L. Zelenkofske3A. Michael Lincoff4Roxana Mehran5P. Gabriel Steg6Christoph Bode7John H. Alexander8Thomas J. Povsic9Duke Health Duke Clinical Research Institute and Duke University Durham NCMontreal Heart Institute, University of Montreal Montreal QCDuke Health Duke Clinical Research Institute and Duke University Durham NCRegado Biosciences Basking Ridge NJCleveland Clinic Coordinating Center for Clinical Research (C5Research) Cleveland OHIcahn School of Medicine at Mount Sinai New York NYUniversité Paris‐Cité Paris FranceUniversity of Freiburg Freiburg GermanyDuke Health Duke Clinical Research Institute and Duke University Durham NCDuke Health Duke Clinical Research Institute and Duke University Durham NCBackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.122.025666arterial accessbleedingoutcomespercutaneous coronary interventionradial |
| spellingShingle | Guillaume Marquis‐Gravel Laurie‐Anne Boivin‐Proulx Zhen Huang Steven L. Zelenkofske A. Michael Lincoff Roxana Mehran P. Gabriel Steg Christoph Bode John H. Alexander Thomas J. Povsic Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease arterial access bleeding outcomes percutaneous coronary intervention radial |
| title | Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention |
| title_full | Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention |
| title_fullStr | Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention |
| title_full_unstemmed | Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention |
| title_short | Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention |
| title_sort | femoral vascular closure devices and bleeding hemostasis and ambulation following percutaneous coronary intervention |
| topic | arterial access bleeding outcomes percutaneous coronary intervention radial |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.122.025666 |
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