Ideally, the perfect antidote should induce immediate, complete, and sustained reversal of the anticoagulant activity correlated with clinical improvement, with no side effects, especially thromboembolic, should be user friendly, and should be available at an acceptable price. 2 This is based on the assumption that by reversing the anticoagulant effects, the antidote restores hemostasis, stops hemorrhage, and therefore reduces mortality. Because rapid vitamin K antagonist reversal reduces mortality of patients facing major bleeding and minimizes hematoma expansion after intracerebral hemorrhage, immediate reversal of DOAC should similarly improve outcomes. However, anticoagulant reversal is unquestionably required in specific situations including urgent invasive procedures, overdose, or life-threatening traumatic or spontaneous bleeding. The short half-life of DOACs compared with warfarin obviates the use of an antidote in most cases. Major bleeding occurs annually in 1% to 3% of DOAC-treated patients and results in high mortality. 1 The results of this study question whether these antidotes fulfill an unmet need and improve DOAC-treated patient outcomes. Recently, after the publication of the ANNEXA-4 study, andexanet alfa, the antidote for factor Xa (FXa) inhibitors, was approved. Idarucizumab was marketed in 2018 for the reversal of the thrombin inhibitor dabigatran.
Nevertheless, the fear of bleeding owing to the lack of a specific antidote has been a major concern.
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