Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center

Andexanet alfa is approved for the reversal of factor Xa inhibitors in patients with major bleeding events. We aimed to review the incidence of effective hemostasis with andexanet alfa in a real-world environment. This retrospective cohort included patients hospitalized for a major bleed that result...

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Main Authors: Victoria M. Stevens PharmD, Toby Trujillo PharmD, FCCP, FAHA, BCPS-AQ Cardiology, Scott W. Mueller PharmD, BCCCP, FCCM, Robert MacLaren PharmD, FCCM, FCCP, Paul M. Reynolds PharmD, BCCCP, Tyree H. Kiser PharmD, FCCM, FCCP, BCPS
Format: Article
Language:English
Published: SAGE Publishing 2019-12-01
Series:Clinical and Applied Thrombosis/Hemostasis
Online Access:https://doi.org/10.1177/1076029619896619
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author Victoria M. Stevens PharmD
Toby Trujillo PharmD, FCCP, FAHA, BCPS-AQ Cardiology
Scott W. Mueller PharmD, BCCCP, FCCM
Robert MacLaren PharmD, FCCM, FCCP
Paul M. Reynolds PharmD, BCCCP
Tyree H. Kiser PharmD, FCCM, FCCP, BCPS
author_facet Victoria M. Stevens PharmD
Toby Trujillo PharmD, FCCP, FAHA, BCPS-AQ Cardiology
Scott W. Mueller PharmD, BCCCP, FCCM
Robert MacLaren PharmD, FCCM, FCCP
Paul M. Reynolds PharmD, BCCCP
Tyree H. Kiser PharmD, FCCM, FCCP, BCPS
author_sort Victoria M. Stevens PharmD
collection DOAJ
description Andexanet alfa is approved for the reversal of factor Xa inhibitors in patients with major bleeding events. We aimed to review the incidence of effective hemostasis with andexanet alfa in a real-world environment. This retrospective cohort included patients hospitalized for a major bleed that resulted in andexanet alfa administration. The primary outcome was effective hemostasis at 12 hours after andexanet alfa treatment. Thromboembolic events and mortality within 30 days were also assessed. Over a 14-month period, 13 patients received andexanet alfa with a mean age of 69 ± 10 years, 54% male, 69% exposed to apixaban (31% rivaroxaban), and had intracranial (46%) and nonintracranial (54%) bleeding sites. Effective hemostasis was observed in 10 (77%) patients. Four (31%) patients experienced 5 thromboembolic events with a median time to event of 6.5 days (range: 0.5-29). Four thrombotic events occurred during the period in which anticoagulation (prophylaxis or therapeutic) was not restarted. Mortality rate was 15%. Andexanet alfa was effective in obtaining hemostasis in a majority of patients. However, the incidence of thromboembolic events was high and may be attributed to a delay in restarting anticoagulation.
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spelling doaj.art-872f665bf08e410e97fa7dc0382f2cb32022-12-21T19:04:12ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232019-12-012510.1177/1076029619896619Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical CenterVictoria M. Stevens PharmD0Toby Trujillo PharmD, FCCP, FAHA, BCPS-AQ Cardiology1Scott W. Mueller PharmD, BCCCP, FCCM2Robert MacLaren PharmD, FCCM, FCCP3Paul M. Reynolds PharmD, BCCCP4Tyree H. Kiser PharmD, FCCM, FCCP, BCPS5 Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USAAndexanet alfa is approved for the reversal of factor Xa inhibitors in patients with major bleeding events. We aimed to review the incidence of effective hemostasis with andexanet alfa in a real-world environment. This retrospective cohort included patients hospitalized for a major bleed that resulted in andexanet alfa administration. The primary outcome was effective hemostasis at 12 hours after andexanet alfa treatment. Thromboembolic events and mortality within 30 days were also assessed. Over a 14-month period, 13 patients received andexanet alfa with a mean age of 69 ± 10 years, 54% male, 69% exposed to apixaban (31% rivaroxaban), and had intracranial (46%) and nonintracranial (54%) bleeding sites. Effective hemostasis was observed in 10 (77%) patients. Four (31%) patients experienced 5 thromboembolic events with a median time to event of 6.5 days (range: 0.5-29). Four thrombotic events occurred during the period in which anticoagulation (prophylaxis or therapeutic) was not restarted. Mortality rate was 15%. Andexanet alfa was effective in obtaining hemostasis in a majority of patients. However, the incidence of thromboembolic events was high and may be attributed to a delay in restarting anticoagulation.https://doi.org/10.1177/1076029619896619
spellingShingle Victoria M. Stevens PharmD
Toby Trujillo PharmD, FCCP, FAHA, BCPS-AQ Cardiology
Scott W. Mueller PharmD, BCCCP, FCCM
Robert MacLaren PharmD, FCCM, FCCP
Paul M. Reynolds PharmD, BCCCP
Tyree H. Kiser PharmD, FCCM, FCCP, BCPS
Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
Clinical and Applied Thrombosis/Hemostasis
title Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
title_full Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
title_fullStr Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
title_full_unstemmed Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
title_short Coagulation Factor Xa (Recombinant), Inactivated-Zhzo (Andexanet Alfa) Hemostatic Outcomes and Thrombotic Event Incidence at an Academic Medical Center
title_sort coagulation factor xa recombinant inactivated zhzo andexanet alfa hemostatic outcomes and thrombotic event incidence at an academic medical center
url https://doi.org/10.1177/1076029619896619
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