What does this research mean for the field?

Among patients with factor Xa inhibitor-associated intracerebral hemorrhage, approximately 63% receive reversal agents in contemporary practice, with early thrombotic events occurring in roughly 6% of cases by hospital discharge. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This analysis aims to update the understanding of reversal agent use and the incidence of thrombotic events in patients with factor Xa inhibitor-associated intracerebral hemorrhage.

May 8, 2026

Abstract Number: Esoc2026a1929 Haematoma Expansion and Thrombotic Events in Patients With Factor Xa-Inhibitor Associated Intracerebral Hemorrhage—interim Analysis of Fire-Xa

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Factor Xa inhibitor-associated intracerebral hemorrhage (n=98). Intervention: Reversal agents (Andexanet alfa or prothrombin complex concentrate) vs. No reversal. Primary outcome: Use of reversal agents and thrombotic events.

Key Result

Among 98 patients with factor Xa inhibitor-associated intracerebral hemorrhage, 63% received reversal agents, with 6 thrombotic events occurring overall by hospital discharge.

Key Points

This analysis aims to update the understanding of reversal agent use and the incidence of thrombotic events in patients with factor Xa inhibitor-associated intracerebral hemorrhage.
Interim analysis of FIRE-Xa (NCT06383741), an international multi-centre study in Switzerland and Germany.
Enrolled consecutive patients with FXaI-associated ICH from 11 sites.
Primary outcomes included reversal agent use and thrombotic events assessed up to hospital discharge.
Of 98 enrolled patients, 63% received haemostatic therapy: 28 received Andexanet alfa, 36 received prothrombin complex concentrate.
Six thrombotic events occurred: 4 ischaemic strokes and 2 systemic embolisms with varied reversal use.
No myocardial infarctions or deep venous thrombosis were observed.

Study Design

Type

Observational (n=98)

Multicenter

Yes

Structured PICO

What is the rate of reversal agent use and subsequent early thrombotic events in patients with factor Xa inhibitor-associated intracerebral hemorrhage?

Population

98 patients with factor Xa inhibitor-associated intracerebral hemorrhage (ICH), median age 81, 42% female, enrolled from 11 sites in Switzerland and Germany.

Intervention

Reversal agents (Andexanet alfa or prothrombin complex concentrate)

Comparator

No reversal therapy

Outcome

Use of reversal agents and thrombotic events (assessed up to hospital discharge)safety

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.

Abstract

Abstract 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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