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Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures

BACKGROUND: Outcomes following andexanet alfa reversal of factor Xa inhibitors in patients requiring urgent or emergent invasive procedures are lacking. This study aimed to describe efficacy and safety outcomes following andexanet alfa administration within 24 h of an invasive procedure. METHODS: Th...

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Autores principales: Bradshaw, Paige Garber, Keegan, Shaun Patrick, Droege, Molly Elizabeth, Dykes, Nicole Jade Harger, Ernst, Neil Edward, Foertsch, Madeline Jane, Makley, Amy Teres, Mueller, Eric William, Philpott, Carolyn Dosen, Srinivasan, Vasisht, Winter, Jessica Brooke, Goodman, Michael D., Droege, Christopher Allen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826450/
https://www.ncbi.nlm.nih.gov/pubmed/36073083
http://dx.doi.org/10.1002/phar.2727
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author Bradshaw, Paige Garber
Keegan, Shaun Patrick
Droege, Molly Elizabeth
Dykes, Nicole Jade Harger
Ernst, Neil Edward
Foertsch, Madeline Jane
Makley, Amy Teres
Mueller, Eric William
Philpott, Carolyn Dosen
Srinivasan, Vasisht
Winter, Jessica Brooke
Goodman, Michael D.
Droege, Christopher Allen
author_facet Bradshaw, Paige Garber
Keegan, Shaun Patrick
Droege, Molly Elizabeth
Dykes, Nicole Jade Harger
Ernst, Neil Edward
Foertsch, Madeline Jane
Makley, Amy Teres
Mueller, Eric William
Philpott, Carolyn Dosen
Srinivasan, Vasisht
Winter, Jessica Brooke
Goodman, Michael D.
Droege, Christopher Allen
author_sort Bradshaw, Paige Garber
collection PubMed
description BACKGROUND: Outcomes following andexanet alfa reversal of factor Xa inhibitors in patients requiring urgent or emergent invasive procedures are lacking. This study aimed to describe efficacy and safety outcomes following andexanet alfa administration within 24 h of an invasive procedure. METHODS: This single‐center, observational, retrospective study included patients who received andexanet alfa within 24 h of an invasive or surgical procedure. The primary outcome was hemostatic efficacy graded as excellent, good, or poor using similar definitions to the ANNEXA‐4 criteria. Secondary outcomes included hospital discharge disposition, intensive care unit (ICU) and hospital length of stay, 30‐day mortality, 30‐day thromboischemic event rates, and serum coagulation assay changes pre‐ and postreversal. RESULTS: Forty‐four patients met inclusion criteria; of these, 27 (62.8%) received apixaban and 16 (37.2%) were treated with rivaroxaban prior to admission. The indications for reversal were categorized as intracranial (n = 20 [45.5%]) or extracranial (n = 24 [54.5%]) sites. Majority of patients required emergent operative procedures (18 [40.9%]), followed by invasive device placement (10 [22.7%]) or arterial embolization (9 [20.5%]). Thirty‐eight (86.4%) patients were able to be adequately graded for hemostatic efficacy. Overall, 30 (78.9%) patients achieved excellent or good hemostasis within 24 h after periprocedural administration of andexanet alfa (19 [82.6%] apixaban vs. 11 [78.6%] rivaroxaban; 12 [80.0%] intracranial events vs. 18 [78.3%] extracranial events). Discharge disposition was most often to a short‐ or long‐term care facilities (27 [61.4%]). Thirty‐day mortality and thromboischemic complications occurred in 15 (34.1%) and 12 (27.3%) patients, respectively. Prothrombin time and antifactor Xa assay results were significantly decreased after andexanet alfa administration (p < 0.05) while thromboelastogram assay values (reaction time, kinetic time, and activated clotting time) showed nonsignificant changes pre‐ versus postreversal. CONCLUSION: Andexanet alfa may be used for urgent or emergent reversal of apixaban and rivaroxaban peri‐procedurally with promising hemostatic outcomes. Further prospective, comparative clinical research is warranted.
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spelling pubmed-98264502023-01-09 Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures Bradshaw, Paige Garber Keegan, Shaun Patrick Droege, Molly Elizabeth Dykes, Nicole Jade Harger Ernst, Neil Edward Foertsch, Madeline Jane Makley, Amy Teres Mueller, Eric William Philpott, Carolyn Dosen Srinivasan, Vasisht Winter, Jessica Brooke Goodman, Michael D. Droege, Christopher Allen Pharmacotherapy Original Research Articles BACKGROUND: Outcomes following andexanet alfa reversal of factor Xa inhibitors in patients requiring urgent or emergent invasive procedures are lacking. This study aimed to describe efficacy and safety outcomes following andexanet alfa administration within 24 h of an invasive procedure. METHODS: This single‐center, observational, retrospective study included patients who received andexanet alfa within 24 h of an invasive or surgical procedure. The primary outcome was hemostatic efficacy graded as excellent, good, or poor using similar definitions to the ANNEXA‐4 criteria. Secondary outcomes included hospital discharge disposition, intensive care unit (ICU) and hospital length of stay, 30‐day mortality, 30‐day thromboischemic event rates, and serum coagulation assay changes pre‐ and postreversal. RESULTS: Forty‐four patients met inclusion criteria; of these, 27 (62.8%) received apixaban and 16 (37.2%) were treated with rivaroxaban prior to admission. The indications for reversal were categorized as intracranial (n = 20 [45.5%]) or extracranial (n = 24 [54.5%]) sites. Majority of patients required emergent operative procedures (18 [40.9%]), followed by invasive device placement (10 [22.7%]) or arterial embolization (9 [20.5%]). Thirty‐eight (86.4%) patients were able to be adequately graded for hemostatic efficacy. Overall, 30 (78.9%) patients achieved excellent or good hemostasis within 24 h after periprocedural administration of andexanet alfa (19 [82.6%] apixaban vs. 11 [78.6%] rivaroxaban; 12 [80.0%] intracranial events vs. 18 [78.3%] extracranial events). Discharge disposition was most often to a short‐ or long‐term care facilities (27 [61.4%]). Thirty‐day mortality and thromboischemic complications occurred in 15 (34.1%) and 12 (27.3%) patients, respectively. Prothrombin time and antifactor Xa assay results were significantly decreased after andexanet alfa administration (p < 0.05) while thromboelastogram assay values (reaction time, kinetic time, and activated clotting time) showed nonsignificant changes pre‐ versus postreversal. CONCLUSION: Andexanet alfa may be used for urgent or emergent reversal of apixaban and rivaroxaban peri‐procedurally with promising hemostatic outcomes. Further prospective, comparative clinical research is warranted. John Wiley and Sons Inc. 2022-09-23 2022-10 /pmc/articles/PMC9826450/ /pubmed/36073083 http://dx.doi.org/10.1002/phar.2727 Text en © 2022 The Authors. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy published by Wiley Periodicals LLC on behalf of Pharmacotherapy Publications, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Research Articles
Bradshaw, Paige Garber
Keegan, Shaun Patrick
Droege, Molly Elizabeth
Dykes, Nicole Jade Harger
Ernst, Neil Edward
Foertsch, Madeline Jane
Makley, Amy Teres
Mueller, Eric William
Philpott, Carolyn Dosen
Srinivasan, Vasisht
Winter, Jessica Brooke
Goodman, Michael D.
Droege, Christopher Allen
Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title_full Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title_fullStr Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title_full_unstemmed Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title_short Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
title_sort reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826450/
https://www.ncbi.nlm.nih.gov/pubmed/36073083
http://dx.doi.org/10.1002/phar.2727
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