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

Division of Hematology and Thromboembolism, Department of Medicine, and. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL. Coagulation Unit, Division of Haematology, Department of Medicine, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden. Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, ON, Canada. Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT; and. Division of General Internal Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.

Blood advances. 2019;3(2):158-167
Abstract
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.
Study details
Study Design : Systematic Review
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine