Management of direct factor Xa inhibitor-related major bleeding with prothrombin complex concentrate: a meta-analysis.


Journal

Blood advances
ISSN: 2473-9537
Titre abrégé: Blood Adv
Pays: United States
ID NLM: 101698425

Informations de publication

Date de publication:
22 01 2019
Historique:
received: 27 07 2018
accepted: 03 11 2018
entrez: 20 1 2019
pubmed: 20 1 2019
medline: 10 1 2020
Statut: ppublish

Résumé

A targeted antidote for reversal of direct factor Xa (FXa) inhibitors is now available for clinical use in the United States, but it is costly and has limited availability. In a systematic review, we evaluated the safety and effectiveness of 4-factor prothrombin complex concentrate (4F-PCC) as an alternative for managing direct FXa inhibitor-related major bleeding. A systematic literature search was conducted using Medline, Embase, and the Cochrane Register of Controlled Trials up to September 2018. No comparative studies were found. Ten case series with 340 patients who received PCC for direct FXa inhibitor-related major bleeding were included. The pooled proportion of patients with effective management of major bleeding was 0.69 (95% confidence interval [CI], 0.61-0.76) in 2 studies using the International Society on Thrombosis and Haemostasis (ISTH) criteria and 0.77 (95% CI, 0.63-0.92) in 8 studies that did not use the ISTH criteria; all-cause mortality was 0.16 (95% CI, 0.07-0.26), and thromboembolism rate was 0.04 (95% CI, 0.01-0.08). On the basis of evidence with very low certainty from single-arm case series, it is difficult to determine whether 4F-PCC in addition to cessation of direct oral FXa inhibitor is more effective than cessation of direct oral FXa inhibitor alone in patients with direct FXa inhibitor-related major bleeding.

Identifiants

pubmed: 30658963
pii: bloodadvances.2018024133
doi: 10.1182/bloodadvances.2018024133
pmc: PMC6341194
doi:

Substances chimiques

Blood Coagulation Factors 0
Factor Xa Inhibitors 0
prothrombin complex concentrates 37224-63-8

Types de publication

Journal Article Meta-Analysis Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

158-167

Informations de copyright

© 2019 by The American Society of Hematology.

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Auteurs

Siavash Piran (S)

Division of Hematology and Thromboembolism, Department of Medicine, and.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Rasha Khatib (R)

Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.

Sam Schulman (S)

Division of Hematology and Thromboembolism, Department of Medicine, and.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Coagulation Unit, Division of Haematology, Department of Medicine, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.

Ammar Majeed (A)

Coagulation Unit, Division of Haematology, Department of Medicine, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.

Anne Holbrook (A)

Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada.

Daniel M Witt (DM)

Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT; and.

Wojtek Wiercioch (W)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Holger J Schünemann (HJ)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Division of General Internal Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.

Robby Nieuwlaat (R)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

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