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Journal Club 1 July 2015


Idarucizumab for Dabigatran Reversal





Specific reversal agents for non–vitamin K antagonist oral anticoagulants are lacking.
Idarucizumab, an antibody fragment, was developed to reverse the anticoagulant
effects of dabigatran.


We undertook this prospective cohort study to determine the safety of 5 g of intravenous
idarucizumab and its capacity to reverse the anticoagulant effects of
dabigatran in patients who had serious bleeding (group A) or required an urgent
procedure (group B). The primary end point was the maximum percentage reversal
of the anticoagulant effect of dabigatran within 4 hours after the administration
of idarucizumab, on the basis of the determination at a central laboratory of the
dilute thrombin time or ecarin clotting time. A key secondary end point was the
restoration of hemostasis.


This interim analysis included 90 patients who received idarucizumab (51 patients
in group A and 39 in group B). Among 68 patients with an elevated dilute thrombin
time and 81 with an elevated ecarin clotting time at baseline, the median
maximum percentage reversal was 100% (95% confidence interval, 100 to 100).
Idarucizumab normalized the test results in 88 to 98% of the patients, an effect
that was evident within minutes. Concentrations of unbound dabigatran remained
below 20 ng per milliliter at 24 hours in 79% of the patients. Among 35 patients
in group A who could be assessed, hemostasis, as determined by local investigators,
was restored at a median of 11.4 hours. Among 36 patients in group B who underwent
a procedure, normal intraoperative hemostasis was reported in 33, and mildly
or moderately abnormal hemostasis was reported in 2 patients and 1 patient, respectively.
One thrombotic event occurred within 72 hours after idarucizumab administration
in a patient in whom anticoagulants had not been reinitiated.


Idarucizumab completely reversed the anticoagulant effect of dabigatran within


Antidote tested in volunteers
The paper editorial is available here.

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