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Thrombosis and Haemostasis | Author Interview 2022-02-20
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Thrombosis and Haemostasis

Author Interview

T&H


Why did you (and your colleagues) write this paper? What was its main purpose?

ALEXANDER BENZ: 

Andexanet alfa (andexanet), administered as a bolus and 2-hour follow-on infusion, is approved for specific anticoagulation reversal in patients with life-threatening or uncontrolled bleeding during treatment with rivaroxaban and apixaban. However, there is limited experience with andexanet in patients treated with the oral factor Xa inhibitor edoxaban. In this paper, we therefore evaluated the efficacy and safety of andexanet in 36 patients (mean age 82 years, 61% male and 92% with atrial fibrillation) with confirmed major bleeding on edoxaban, the majority of whom had intracranial hemorrhage (81%).

T&H


What are the main conclusions?

ALEXANDER BENZ: 

In the efficacy population including 28 patients with baseline anti-factor Xa activity ≥40 ng/mL, andexanet decreased the median anti-factor Xa activity by 68.9% (95% confidence interval [CI] 56.1-77.7%) from baseline to the end of bolus. Effective hemostasis at 12 hours according to prespecified criteria was achieved in 78.6% (95% CI 59.0-91.7%) of patients. Within 30 days, 4 patients (11%) experienced a thrombotic event and 4 others (11%) died.

T&H


What are the paper’s implications?- to the public?-to medical professionals?

ALEXANDER BENZ: 

Consistent with the pharmacological properties of edoxaban, the reduction in anti-factor Xa activity with andexanet seems to be somewhat smaller compared to that observed in patients receiving andexanet for reversal of rivaroxaban or apixaban. However, this did not appear to have an effect on hemostatic efficacy. 30-day rates of thrombotic events and death in patients treated with edoxaban were similar to the results obtained in patients receiving andexanet for major bleeding on the other two oral factor Xa inhibitors. Up until now, no drug has received regulatory approval for specific anticoagulation reversal of edoxaban.

T&H


Are the findings clinically significant? Should the findings change practice?

ALEXANDER BENZ: 

A.B: We believe our results represent important data supporting the use of andexanet in patients with acute major bleeding on edoxaban, in particular in those who experience an intracranial hemorrhage. However, andexanet should not be used routinely in patients experiencing bleeding on edoxaban until regulatory approval has been obtained.

New Technologies, Diagnostic Tools and Drugs

Andexanet Alfa for Specific Anticoagulation Reversal in Patients with Acute Bleeding during Treatment with Edoxaban

Benz et al.

CC BY-NC-ND 4.0 · Thromb Haemost
DOI: 10.1055/s-0041-1740180