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. 2025 Dec 3:S1538-7836(25)00841-4.
doi: 10.1016/j.jtha.2025.11.003. Online ahead of print.

A UK-wide analysis of 2265 patients receiving a reversal agent for direct oral anticoagulant-associated bleeding

HaemSTAR Collaborators. Electronic address: https://x.com/haemstar_uk; HaemSTAR Collaborators
Collaborators
Free article

A UK-wide analysis of 2265 patients receiving a reversal agent for direct oral anticoagulant-associated bleeding

HaemSTAR Collaborators. Electronic address: https://x.com/haemstar_uk et al. J Thromb Haemost. .
Free article

Abstract

Background: Reversal agents are used in patients taking direct oral anticoagulants (DOACs) to manage bleeding, but evidence for their effectiveness remains limited.

Objectives: This study assessed the proportion of patients treated with a reversal agent for DOAC-associated bleeding who had major bleeding and evaluated their outcomes.

Methods: This was a retrospective, observational audit across 65 hospitals in the United Kingdom. Adults who received andexanet alfa, idarucizumab, or 4-factor prothrombin complex concentrate (4F-PCC) for DOAC-associated bleeding between October 2020 and June 2023 were included. Data were collected on demographics, medical history, bleed site and severity, reversal agent, thrombosis, and 90-day mortality. A propensity score-matched analysis was performed to estimate the cumulative incidence of thrombosis and death according to reversal agent in gastrointestinal hemorrhage.

Results: Of 2265 patients, 875 (38.6%) had gastrointestinal bleeding and 1012 (44.7%) had intracranial hemorrhage. Median age was 81 years. Median time from bleed onset to reversal was 6.5 hours, and that from last anticoagulant dose was 16.0 hours. Of 1253 patients with nonintracranial bleeds, 1001 (79.9%) had major hemorrhage. In a propensity score-matched analysis of 494 patients with gastrointestinal bleeding, there was no significant difference in 90-day-mortality with andexanet alfa compared with that with 4F-PCC (36.4% vs 32.4%), but andexanet alfa was associated with a significantly increased 30-day incidence of stroke (4.5% vs 0%).

Conclusion: Reversal agents were generally used in patients with clinical evidence of major bleeding but were administered long after the last anticoagulant dose. In gastrointestinal bleeding, andexanet alfa was associated with a higher thrombotic risk than 4F-PCC.

Keywords: andexanetalfa; anticoagulants; factor Xa inhibitors; gastrointestinal hemorrhage; prothrombin complex concentrate.

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Conflict of interest statement

Declaration of competing interests R.J.B. and P.L.R.N. were named applicants on the grant to AstraZeneca UK Limited, which was awarded to HaemSTAR. P.L.R.N. has received honoraria from AstraZeneca and Takeda. R.J.B. has received honoraria from Takeda. A.D. has received honoraria from AstraZeneca. G.L. has received honoraria from CSL Behring. R.A. has received consulting fees and honoraria from AstraZeneca.

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