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Real-world experience with reversal of dabigatran by idarucizumab

Authors: Haastrup, Simone Bonde; Poulsen, Maja Hellfritzsch; Nybo, Mads; Hvas, Anne-Mette; Grove, Erik Lerkevang;

Real-world experience with reversal of dabigatran by idarucizumab

Abstract

Idarucizumab reverses the anticoagulant effect of dabigatran. We aimed to investigate real-world experience with idarucizumab and associated clinical outcomes.We conducted a retrospective observational case series on dabigatran users treated with idarucizumab. Using electronic patient records, we identified patients from December 2015 (market introduction) to 31 December 2019 from the Central Denmark Region, covering approximately 1.3 million inhabitants. Treatment indications included need of acute surgery, major bleeding, dabigatran intoxication and need of thrombolysis. Outcomes were defined according to treatment indication, and adverse events were defined as bleeding, thrombosis or death within 30 days of infusion.A total of 46 dabigatran users were treated with idarucizumab. All patients except one received dabigatran due to atrial fibrillation. Indications for idarucizumab use were need of acute surgery in 22 (48%), severe bleeding in 20 (43%), dabigatran intoxication in three (7%), and prior to thrombolysis in acute stroke in one (2%) patient. There were no reports of excessive bleeding during surgery in patients reversed just prior to surgery. For patients presenting with severe bleeding, all but one achieved effective haemostasis. Among all patients receiving idarucizumab, six (13%) experienced bleeding within 30 days after infusion. None experienced thromboembolic complications. At 30 days follow-up, 38 (83%) patients were alive of whom 35 (92%) had restarted anticoagulant treatment.This study of real-world application of idarucizumab demonstrated effectiveness in terms of surgery performed without excessive bleeding and cessation of severe bleeding in dabigatran-treated patients. Safety appeared high as no patients experienced thromboembolic complications within 30 days.

Country
Denmark
Keywords

Haemorrhage, Observational study, Idarucizumab, Humans, Antibodies, Monoclonal, Humanized, Atrial fibrillation, Antithrombins, Dabigatran, Retrospective Studies

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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citations
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
14
Top 10%
Top 10%
Top 10%
Green
hybrid