BACKGROUND: The development of novel oral anticoagulants (NOACs) has 
revolutionized oral anticoagulation. Rapid incorporation of NOACs into general 
practice has heightened the demand for directed reversal agents. Idarucizumab is 
a targeted reversal agent that is approved for the urgent reversal of the 
anticoagulant effects of dabigatran. While it is a welcome addition to reversal 
strategies of dabigatran, a number of clinical questions exist regarding its 
place in therapy.
OBJECTIVE: We describe controversies regarding the use of idarucizumab therapy 
in patients with dabigatran-associated bleeding.
DISCUSSION: Although existing clinical studies show a rapid reversal of 
coagulation assays, these studies did not describe a corresponding improvement 
in mortality or rapid cessation of hemorrhage. It is questionable how heavily 
clinicians can rely upon the use of the surrogate endpoints in clinical studies, 
such as ecarin clotting time and dilute thrombin time. Another issue is whether 
patients exhibiting re-elevation of coagulation assays would benefit from an 
additional dose of idarucizumab, because this has not been studied. It is 
currently unclear if blood products must be given in addition to idarucizumab 
can be used as monotherapy.
CONCLUSIONS: The initial data suggest a definite role for idarucizumab in 
treatment of bleeding associated with dabigatran. As more clinical practice 
experience is gained with the agent and the remaining data on its use are 
released, clinicians can better guide the clinical use of idarucizumab. At 
present, there is currently not enough evidence for idarucizumab to be used as 
monotherapy.