Key result
Reversal agents are used in 63% of factor Xa inhibitor-associated ICHs with few overall thrombotic events.
Why the study?
Reversal therapy to prevent haematoma expansion in factor Xa inhibitor-associated intracerebral hemorrhage may increase thrombotic risk, warranting an updated assessment of reversal agent use and early thrombotic events.
What is the rate of reversal agent use and subsequent early thrombotic events in patients with factor Xa inhibitor-associated intracerebral hemorrhage?
Observational (n=98)
Yes
What is the rate of reversal agent use and subsequent early thrombotic events in patients with factor Xa inhibitor-associated intracerebral hemorrhage?
Answers are grounded in this paper and cite their sources.
In a real-world cohort of patients with factor Xa inhibitor-associated intracerebral hemorrhage, reversal agents were used in 63% of cases, with a low overall rate of early thrombotic events.
Background and aims Intracerebral hemorrhage (ICH) associated with recent factor Xa inhibitor (FXaI) intake warrants reversal therapy to prevent haematoma expansion but may increase the risk of thrombotic events (TE). We thought to provide a contemporary update on the use of reversal agents and early TEs. Methods This is an interim-analysis of FIRE-Xa (NCT06383741), a prospective, international multi-centre study enrolling consecutive patients with FXaI-associated ICH from 11 sites in Switzerland and Germany. Primary outcome for this analysis is use of reversal agents (Andexanet alfa = AA, prothrombin complex concentrate = PCC or no reversal) and TE (assessed up hospital discharge). Results By December 1, 2025, we enrolled 98 patients in FIRE-Xa. The median age was 81 years (IQR 76-85), 42% were female, the NIHSS at admission was 9 (IQR 3-14), median drug-specific anti-Xa activity was 124 ng/ml (IQR 68-217) and the median duration of hospitalization was 9 days (IQR 6-14). Among 62 patients (63%) receiving any haemostatic therapy, 28 patients received AA and 36 patients received PCC (2 patients received both). Overall, 6 TEs occurred (4 ischaemic stroke: 1 no reversal, 1 AA, 2 PCC), 2 systemic embolism: 1 no reversal, 1 PCC). No patient had myocardial infarction or deep venous thrombosis. Conclusions This study provides real-world data on the contemporary use of reversal agents in patients with FXaI-associated ICH and early TE. Conflict of interest Janis Rauch: nothing to disclose.
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Rauch et al. (2026) conducted an observational in Factor Xa inhibitor-associated intracerebral hemorrhage (n=98). Reversal agents (Andexanet alfa or prothrombin complex concentrate) vs. No reversal was evaluated on Use of reversal agents and thrombotic events. Among 98 patients with factor Xa inhibitor-associated intracerebral hemorrhage, 63% received reversal agents, with 6 thrombotic events occurring overall by hospital discharge.
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