Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events

Background: Both andexanet alfa and 4F-PCC reversal strategies have been associated with thrombotic events. It remains unclear whether the risk is associated with the reversal agent or the lack of re-initiation of anticoagulation. Objective: The aim of this study was to describe anticoagulant (AC) r...

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Main Authors: Awatif Hafiz, Alshaya Abdulrahman I, Katelyn W. Sylvester, Jean M. Connors, Jessica Rimsans
Format: Article
Language:English
Published: Elsevier 2021-12-01
Series:Thrombosis Update
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666572721000456
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spelling doaj-32e0f2c793b840a1bdd6396d649c76382021-10-09T04:41:39ZengElsevierThrombosis Update2666-57272021-12-015100076Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding eventsAwatif Hafiz0Alshaya Abdulrahman I1Katelyn W. Sylvester2Jean M. Connors3Jessica Rimsans4Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi ArabiaPharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia; College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, Riyadh, Saudi ArabiaDepartment of Pharmacy Services, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USADivision of Hematology, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USADepartment of Pharmacy Services, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Corresponding author. Department of Pharmacy, Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02215, USA.Background: Both andexanet alfa and 4F-PCC reversal strategies have been associated with thrombotic events. It remains unclear whether the risk is associated with the reversal agent or the lack of re-initiation of anticoagulation. Objective: The aim of this study was to describe anticoagulant (AC) re-initiation patterns in patients presenting with major bleeding while on a FXai requiring reversal, and to describe associated post-reversal thrombotic events. Methods: This was a single-center retrospective cohort study. Patients were included if they received FXai reversal with andexanet alfa or 4F-PCC for major bleeding. Results: Fifty-seven patients met inclusion criteria; of these patients, 34 received andexanet alfa and 23 patients received 4F-PCC. Most patients were prescribed AC for atrial fibrillation. The most common indications for reversal were intracranial hemorrhage 68%, followed by gastrointestinal bleeding 19%. AC was re-initiated at either prophylactic or therapeutic doses in 59% in the andexanet alfa recipients and 65% in the 4F-PCC recipients within 30 days. In those who restarted AC within 30 days, the median time to re-initiate AC was three days [IQR: 1–3]. Thrombotic events occurred in 3% of patients in the andexanet alfa group and 13% in the 4F-PCC group (7% overall rate). None were receiving anticoagulation at the time of the event. Conclusion: Anticoagulation was restarted in approximately half of the patients who received a reversal agent for a life-threatening bleed. The thrombotic risk was 7% at the 30 day follow up period. Continuous assessment of bleeding and thrombosis is important for post-reversal management of patients with major bleeding events.http://www.sciencedirect.com/science/article/pii/S2666572721000456Andexanet alfaProthrombin complex concentrateReversalAnticoagulationHemostasisMajor bleeding event
collection DOAJ
language English
format Article
sources DOAJ
author Awatif Hafiz
Alshaya Abdulrahman I
Katelyn W. Sylvester
Jean M. Connors
Jessica Rimsans
spellingShingle Awatif Hafiz
Alshaya Abdulrahman I
Katelyn W. Sylvester
Jean M. Connors
Jessica Rimsans
Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
Thrombosis Update
Andexanet alfa
Prothrombin complex concentrate
Reversal
Anticoagulation
Hemostasis
Major bleeding event
author_facet Awatif Hafiz
Alshaya Abdulrahman I
Katelyn W. Sylvester
Jean M. Connors
Jessica Rimsans
author_sort Awatif Hafiz
title Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
title_short Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
title_full Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
title_fullStr Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
title_full_unstemmed Evaluation of anticoagulation re-initiation practices following reversal of factor Xa inhibitors with andexanet alfa or 4F-PCC in patients with major bleeding events
title_sort evaluation of anticoagulation re-initiation practices following reversal of factor xa inhibitors with andexanet alfa or 4f-pcc in patients with major bleeding events
publisher Elsevier
series Thrombosis Update
issn 2666-5727
publishDate 2021-12-01
description Background: Both andexanet alfa and 4F-PCC reversal strategies have been associated with thrombotic events. It remains unclear whether the risk is associated with the reversal agent or the lack of re-initiation of anticoagulation. Objective: The aim of this study was to describe anticoagulant (AC) re-initiation patterns in patients presenting with major bleeding while on a FXai requiring reversal, and to describe associated post-reversal thrombotic events. Methods: This was a single-center retrospective cohort study. Patients were included if they received FXai reversal with andexanet alfa or 4F-PCC for major bleeding. Results: Fifty-seven patients met inclusion criteria; of these patients, 34 received andexanet alfa and 23 patients received 4F-PCC. Most patients were prescribed AC for atrial fibrillation. The most common indications for reversal were intracranial hemorrhage 68%, followed by gastrointestinal bleeding 19%. AC was re-initiated at either prophylactic or therapeutic doses in 59% in the andexanet alfa recipients and 65% in the 4F-PCC recipients within 30 days. In those who restarted AC within 30 days, the median time to re-initiate AC was three days [IQR: 1–3]. Thrombotic events occurred in 3% of patients in the andexanet alfa group and 13% in the 4F-PCC group (7% overall rate). None were receiving anticoagulation at the time of the event. Conclusion: Anticoagulation was restarted in approximately half of the patients who received a reversal agent for a life-threatening bleed. The thrombotic risk was 7% at the 30 day follow up period. Continuous assessment of bleeding and thrombosis is important for post-reversal management of patients with major bleeding events.
topic Andexanet alfa
Prothrombin complex concentrate
Reversal
Anticoagulation
Hemostasis
Major bleeding event
url http://www.sciencedirect.com/science/article/pii/S2666572721000456
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