What is the clinical evidence from this study?

Study design: Review. Population: Oral factor Xa inhibitor-associated bleeding. Intervention: Andexanet alfa vs. Usual care (including 4F-PCC). Primary outcome: Haemostatic efficacy (p=0.003).

April 27, 2026British Journal of HaematologyOpen Access

Use of andexanet alfa: A British Society for Haematology position statement

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Why the study?

Serious arterial and venous thromboembolic risks and conflicting regulatory opinions prompted evaluation of the benefit-risk balance of andexanet alfa for factor Xa inhibitor-associated bleeding.

Does andexanet alfa provide a favorable benefit-risk profile compared to usual care for reversing anticoagulation in patients with life-threatening bleeding on direct factor Xa inhibitors?

Design

Society position statement

Authors

RBRichard J. Buka DADeepa J. Arachchillage CBCatherine BagotNHS Greater Glasgow and Clyde

Discussion

Member takes

Implication

Supports the efficacy of andexanet alfa for FXa inhibitor reversal in severe bleeding; leaves open the.

Key Points

This position statement evaluates the use of andexanet alfa for reversing anticoagulation in patients with life-threatening bleeding while weighing its risks and benefits.
Review of the status and recommendations regarding andexanet alfa in the UK.
Evaluation of data from trials including ANNEXA-4 and ANNEXA-I related to efficacy and safety outcomes.
Assessment of various observational studies and their implications for clinical practice.
Andexanet alfa achieved good haemostatic efficacy in 80.1% of patients in the ANNEXA-4 trial but lacked comparator data to confirm clinical relevance.
In the ANNEXA-I trial, 67.0% of patients using andexanet alfa met the primary endpoint compared to 53.1% in usual care (p = 0.003).
Thrombosis rate with andexanet alfa was higher (10.3%) compared to usual care (5.6%) (p = 0.048), raising safety concerns.

Structured PICO

Does andexanet alfa provide a favorable benefit-risk profile compared to usual care for reversing anticoagulation in patients with life-threatening bleeding on direct factor Xa inhibitors?

Population

Adult patients treated with a direct factor Xa inhibitor (apixaban or rivaroxaban) presenting with life-threatening or uncontrolled bleeding

Intervention

Andexanet alfa

Comparator

Usual care or four-factor prothrombin complex concentrate (4F-PCC)

Outcome

Clinical benefit versus risk of thromboembolic eventssafety

Main Result

Absolute Event Rate: 67% vs 53.1%

p-value: p=0.003

This British Society for Haematology position statement cautions against the routine use of andexanet alfa for factor Xa inhibitor reversal due to an unfavorable risk-benefit profile driven by excess thromboembolic events.

Limitations

Lack of comparator in ANNEXA-4 makes it impossible to discern causal association or clinical relevance.
ANNEXA-4 outcomes for visible bleeding were based on subjective investigator assessment.
ANNEXA-I was not powered to detect differences in survival or disability at 30 days.
Andexanet alfa is not licensed for reversal of edoxaban, heparin-based anticoagulants, or prior to urgent surgery.

Cite This Study

Buka et al. (2026) conducted a review in Oral factor Xa inhibitor-associated bleeding. Andexanet alfa vs. Usual care (including 4F-PCC) was evaluated on Haemostatic efficacy (p=0.003). Andexanet alfa use for factor Xa inhibitor bleeding is considered by the British Society for Haematology to have risks outweighing benefits due to increased thrombosis (10.3% vs 5.6%, P=0.048).

synapsesocial.com/papers/69eefd64fede9185760d41fd https://doi.org/10.1111/bjh.70509

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Use of andexanet alfa: A British Society for Haematology position statement

Discussion

Member takes

Implication

Key Points

Structured PICO

Main Result

Limitations

Cite This Study

Use of andexanet alfa: A British Society for Haematology position statement

Discussion

Member takes

Implication

Key Points

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider