Key result
Andexanet alfa administration in patients with acute major bleeding on edoxaban decreased antifactor Xa activity by 68.9% and achieved excellent or good hemostasis in 78.6% (95% CI 59.0-91.7%).
Why the study?
Andexanet alfa is approved to reverse rivaroxaban or apixaban, but there is limited experience with its use in patients with acute bleeding on edoxaban.
Does andexanet alfa improve hemostasis and reduce antifactor Xa activity in patients with acute major bleeding on edoxaban?
Does andexanet alfa improve hemostasis and reduce antifactor Xa activity in patients with acute major bleeding on edoxaban?
Andexanet alfa effectively reduces antifactor Xa activity and achieves good hemostasis in patients with acute major bleeding on edoxaban, extending its known efficacy beyond rivaroxaban and apixaban.
Supports andexanet alfa for edoxaban reversal; leaves open confirmation in randomized trials.
BACKGROUND: Andexanet alfa (andexanet) is approved for specific anticoagulation reversal in patients with life-threatening or uncontrolled bleeding during treatment with rivaroxaban or apixaban. There is limited experience with andexanet in patients with acute bleeding on edoxaban. METHODS: Patients with acute major bleeding within 18 hours of edoxaban intake were prospectively enrolled. Patients received a bolus and 2-hour follow-on infusion of andexanet. The co-primary efficacy outcomes were change in antifactor Xa activity and the percentage of patients achieving excellent or good hemostasis, 12 hours after andexanet treatment. Efficacy was analyzed in patients with confirmed major bleeding and baseline antifactor Xa activity ≥40 ng/mL. Safety was analyzed in all patients. RESULTS: = 28), median antifactor Xa activity decreased from 121.1 (interquartile range [IQR]: 70.3-202.4) ng/mL at baseline to 24.0 (IQR: 77.7-83.7) ng/mL at the end of andexanet bolus (median decrease: 68.9%, 95% confidence interval [CI]: 56.1-77.7%). Excellent or good hemostasis at 12 hours was achieved in 78.6% (95% CI: 59.0-91.7%) of patients. Within 30 days, four patients (11.1%) experienced a thrombotic event and four others (11.1%) died. CONCLUSION: In patients with acute major bleeding on edoxaban, andexanet significantly decreased antifactor Xa activity. Hemostatic efficacy was similar to that observed in patients with bleeding on rivaroxaban or apixaban. Thrombotic events occurred at a rate expected in such patients.
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Benz et al. (2022) studied Acute major bleeding during treatment with edoxaban (n=36). Andexanet alfa was evaluated on change in antifactor Xa activity and the percentage of patients achieving excellent or good hemostasis, 12 hours after andexanet treatment (95% CI 59.0-91.7). Andexanet alfa administration in patients with acute major bleeding on edoxaban decreased antifactor Xa activity by 68.9% and achieved excellent or good hemostasis in 78.6% (95% CI 59.0-91.7%).
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