Abstract 213: Effect of Idarucizumab on Intracranial Bleeding in Dabigatran-treated Patients

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Introduction: Dabigatran is a non-vitamin K antagonist oral anticoagulant (NOAC) licensed for stroke prevention in nonvalvular atrial fibrillation. In the RE-LY trial, both doses of dabigatran (110 mg and 150 mg bid) were associated with a significantly lower annualized rate of intracranial hemorrhage (ICH) than warfarin (0.23%, 0.32% and 0.76%, respectively). Nonetheless, the mortality rate with ICH in the context of any anticoagulation remains high, probably reflecting the effects of hematoma expansion. Whether a specific reversal agent for dabigatran will improve clinical outcomes in dabigatran-treated patients with ICH is unknown. RE-VERSE AD is an ongoing, open-label, phase 3, cohort study evaluating the extent to which idarucizumab, a humanized Fab fragment directed against dabigatran, reverses the latter’s anticoagulant effects in patients with serious bleeding or in those requiring urgent interventions. This study focuses on the results in patients with ICH.

Hypothesis: Compared with historical controls, idarucizumab improves clinical outcomes in dabigatran-treated patients with ICH.

Methods: Patients presenting with ICH were given intravenous idarucizumab 5 g as two 2.5 g bolus infusions administered no more than 15 minutes apart. The primary endpoint was the maximum reversal of the anticoagulant effect of dabigatran, based on central laboratory determination of the dilute thrombin time or ecarin clotting time.

Results: In an interim analysis at 90 patients, 18 with ICH had been enrolled in RE-VERSE AD. Updated results on the effects of idarucizumab on coagulation parameters, imaging studies, and clinical outcomes in this patient subgroup will be presented.

Conclusions: Currently, there are no specific reversal agents for the NOACs. We present the first data on the clinical outcomes for idarucizumab in dabigatran-treated patients who present with ICH.

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