Safety and effectiveness of Factor Eight Inhibitor Bypassing Activity for direct oral anticoagulant-related hemorrhage reversal.


Journal

The American journal of emergency medicine
ISSN: 1532-8171
Titre abrégé: Am J Emerg Med
Pays: United States
ID NLM: 8309942

Informations de publication

Date de publication:
02 2019
Historique:
received: 22 02 2018
revised: 09 04 2018
accepted: 13 05 2018
pubmed: 29 5 2018
medline: 28 10 2019
entrez: 27 5 2018
Statut: ppublish

Résumé

The incidence of patients who present with life-threatening bleeding complications has been increasing as the use of direct oral anticoagulation (DOAC) has increased. Therefore, effective reversal agents are urgently needed. Current guidelines recommend the use of prothrombin complex concentrates (PCCs) and activated PCCs (aPCC) for reversal of DOAC anticoagulant activity in the setting of traumatic and non-traumatic intracranial hemorrhage (ICH). However, little data is available. Herein, we investigated the safety and effectiveness of Factor Eight Inhibitor Bypassing Activity [FEIBA (an aPCC)] in a population of patients who required emergent reversal of DOAC for hemorrhage or urgent surgical interventions. This is a case series study. Medical records from patients who required emergent reversal of DOAC for life threatening hemorrhage or urgent surgical interventions were collected from February 1, 2014, to April 1, 2017 and reviewed. Data, including demographics as well as safety, outcomes, and dosing of FEIBA for reversal of DOAC effects were collected and descriptive statistics were obtained. Forty-two patients who received FEIBA were included in the study. The rates of thrombotic events (10%), hemorrhage progression (10%), and observed mortality (29%) were similar to rates previously published in the limited literature evaluating aPCC use in this population. This case series suggests that FEIBA administration is relatively safe and effective to reverse DOACs in the setting of hemorrhage or need for urgent surgical procedures. Until target-specific reversal agents are available, future studies are warranted to evaluate the effectiveness of aPCC administration for DOAC-associated hemorrhagic complications.

Sections du résumé

BACKGROUND
The incidence of patients who present with life-threatening bleeding complications has been increasing as the use of direct oral anticoagulation (DOAC) has increased. Therefore, effective reversal agents are urgently needed. Current guidelines recommend the use of prothrombin complex concentrates (PCCs) and activated PCCs (aPCC) for reversal of DOAC anticoagulant activity in the setting of traumatic and non-traumatic intracranial hemorrhage (ICH). However, little data is available.
OBJECTIVE
Herein, we investigated the safety and effectiveness of Factor Eight Inhibitor Bypassing Activity [FEIBA (an aPCC)] in a population of patients who required emergent reversal of DOAC for hemorrhage or urgent surgical interventions.
METHODS
This is a case series study. Medical records from patients who required emergent reversal of DOAC for life threatening hemorrhage or urgent surgical interventions were collected from February 1, 2014, to April 1, 2017 and reviewed. Data, including demographics as well as safety, outcomes, and dosing of FEIBA for reversal of DOAC effects were collected and descriptive statistics were obtained.
RESULTS
Forty-two patients who received FEIBA were included in the study. The rates of thrombotic events (10%), hemorrhage progression (10%), and observed mortality (29%) were similar to rates previously published in the limited literature evaluating aPCC use in this population.
CONCLUSION
This case series suggests that FEIBA administration is relatively safe and effective to reverse DOACs in the setting of hemorrhage or need for urgent surgical procedures. Until target-specific reversal agents are available, future studies are warranted to evaluate the effectiveness of aPCC administration for DOAC-associated hemorrhagic complications.

Identifiants

pubmed: 29802004
pii: S0735-6757(18)30400-5
doi: 10.1016/j.ajem.2018.05.023
pii:
doi:

Substances chimiques

Anticoagulants 0
Blood Coagulation Factors 0
Coagulants 0
anti-inhibitor coagulant complex CS849DUN3M

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

214-219

Informations de copyright

Copyright © 2018 Elsevier Inc. All rights reserved.

Auteurs

Jacklyn M Engelbart (JM)

University of Iowa Carver College of Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.

Anne Zepeski (A)

Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.

Colette Galet (C)

Department of Surgery, Division of Acute Care Surgery, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.

Bruno Policeni (B)

Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.

Dionne A Skeete (DA)

Department of Surgery, Division of Acute Care Surgery, University of Iowa Hospitals and Clinics, Iowa City, IA, United States.

Brett A Faine (BA)

Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics, Iowa City, IA, United States; Department of Emergency Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, United States. Electronic address: brett-faine@uiowa.edu.

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