Key result
Idarucizumab rapidly normalizes aPTT to ~30 seconds, enabling pericardiocentesis in dabigatran-induced hemopericardium.
Why the study?
Clinical data on idarucizumab for reversal of dabigatran-associated anticoagulation needed to be reviewed to assess safety, tolerability, and efficacy.
Case Report (n=1)
No
Answers are grounded in this paper and cite their sources.
Supports idarucizumab for dabigatran reversal in spontaneous hemopericardium; extends RE-VERSE AD data to this rare site.
OBJECTIVE: To review clinical data on idarucizumab for the reversal of dabigatran-associated anticoagulation. DATA SOURCES: Articles for this review were identified via PubMed using the MeSH term dabigatran combined with the keyword idarucizumab Additional online searches via PubMed and Google Scholar were conducted for both prescribing and cost information. STUDY SELECTION AND DATA EXTRACTION: English-language clinical trials published between 1946 and May 2016 were included for review. Bibliographies of selected articles were also manually reviewed for relevant publications that focused on reversal strategies for dabigatran-associated anticoagulation. DATA SYNTHESIS: The safety and tolerability of idarucizumab has been evaluated in 3 phase I clinical trials. The use of idarucizumab for reversing dabigatran-associated anticoagulation is also being evaluated in the phase III RE-VERSE AD study. Interim results of the RE-VERSE AD study have been published. CONCLUSIONS: Idarucizumab rapidly neutralizes the anticoagulant effect of dabigatran in healthy volunteers, in patients with life-threatening bleeding, and in patients requiring urgent surgery that cannot be delayed. These observations are largely based on laboratory assessments rather than clinical outcomes. Idarucizumab is well tolerated, and it does not appear to induce procoagulant or immunogenic adverse effects.
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Yogaratnam et al. (2016) conducted a case report in Dabigatran-associated hemopericardium (n=1). Idarucizumab was evaluated on Normalization of activated partial thromboplastin time (aPTT). Idarucizumab rapidly normalized aPTT from 47.7 to 29.5 seconds and facilitated life-saving pericardiocentesis in a patient with dabigatran-associated spontaneous hemopericardium.
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