ANNEXA-1: Andexanet Alfa Associated with Harm in DOAC Reversal
REBEL Cast
00:00
Critical Insights on DOAC Reversal Trial Biases
This chapter critically examines a clinical trial funded by the pharmaceutical company that created a DOAC reversal medication. It raises concerns about biases in reporting safety endpoints and highlights the importance of real-world outcomes for patient care.
Transcript
Play full episode
Background: In May of 2018, Andexanet alfa gained accelerated approval by the FDA for the reversal direct oral anticoagulants (DOACs) despite a lack of robust evidence for use. The 2022 AHA/ASA guidelines give the drug a level 2A recommendation and recommend it over the use of 4F-PCC (Greenberg 2022). FDA approval alongside guideline endorsement has ... 
