A Systematic and Evidence-Based Review of Published and Pending Reports of Andexanet Alfa.

Andexanet alfa is the newly approved factor Xa inhibitor reversal agent for the treatment of life-threatening or uncontrolled bleeding from apixaban or rivaroxaban. This decoy protein directly binds factor Xa inhibitors reversing their action. A systematic and evidence-based evaluation of the available clinical trials is lacking in the literature. This research will provide a systematic and evidence-based evaluation of published clinical trials for andexanet alfa. It will also present an evaluation of active research. Reports of research were identified through multiple databases using search terms andexanet alfa, andexanet, or PRT064445. The level of evidence and strength of recommendation were accomplished using the Strength of Recommendation Taxonomy. There are 2 published articles presenting 3 clinical trials. Two trials had a low level of evidence and the third trial, a preliminary report of results, showed a moderate level of evidence. The review of active research found 3 unique studies and a preliminary results study. The level of evidence is low for 2 of these studies, moderate for a third, and potentially high for the fourth. The strength of recommendation for all 6 studies is a C. Four of the studies present disease-oriented evidence resulting in a low level of evidence. Another study is unblinded and uncontrolled but presents patient-oriented evidence resulting in a moderate level of evidence. Only one study could score high because the outcome is patient-oriented evidence, and it could achieve follow-up of 80%. There is a need for well-controlled and blinded evaluation to improve the recommendation strength.