What question did this study set out to answer?

To review the pharmacology, clinical development, and trial evidence for andexanet alfa as a reversal agent for factor Xa inhibitors during life-threatening bleeding.

April 11, 2019Expert Opinion on Biological TherapyOpen Access

Andexanet alfa for the reversal of factor Xa inhibitors

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Why the study?

Does andexanet alfa reverse the effects of factor Xa inhibitors in patients with life-threatening or uncontrolled bleeding?

Design

Review

Authors

JFJulien FavresseUniversity of Namur MHMichaël HardyCHU Dinant Godinne UCL Namur MDMarie‐Astrid van DievoetCliniques Universitaires Saint-Luc

Discussion

Member takes

Implication

May support andexanet alfa for factor Xa inhibitor bleeding; leaves open need for randomized comparisons.

Key Points

To review the pharmacology, clinical development, and trial evidence for andexanet alfa as a reversal agent for factor Xa inhibitors during life-threatening bleeding.
Overview of pharmacokinetic and pharmacodynamic data across phase I through phase III ANNEXA clinical trials.
Evaluation of regulatory authorizations and clinical practice limitations for factor Xa inhibitor reversal.
Andexanet alfa demonstrates effective reversal of anticoagulant activity for apixaban and rivaroxaban in major bleeding.
Phase III clinical evidence is currently constrained by the absence of an active comparator control arm, necessitating further comparative trials.

Structured PICO

Does andexanet alfa reverse the effects of factor Xa inhibitors in patients with life-threatening or uncontrolled bleeding?

Population

Patients treated with apixaban and rivaroxaban in case of life-threatening or uncontrolled bleeding

Intervention

Andexanet alfa

Outcome

Reversal of factor Xa inhibitors

Andexanet alfa is an effective reversal agent for apixaban and rivaroxaban in life-threatening bleeding, but well-designed comparative studies are still needed.

Limitations

Efficacy in major bleeding patients has only been shown without any comparator group

Cite This Study

Favresse et al. (2019) studied this question.

synapsesocial.com/papers/6a83e7cb8df3fed3c85bdb8b https://doi.org/10.1080/14712598.2019.1599355

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Andexanet alfa for the reversal of factor Xa inhibitors

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Andexanet alfa for the reversal of factor Xa inhibitors

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider