Key result
Idarucizumab reverses dabigatran in real-world emergencies, linked to ~83% survival without short-term thromboembolic complications.
Why the study?
Idarucizumab reverses the anticoagulant effect of dabigatran, but real-world experience with its use and associated clinical outcomes needed investigation.
Does idarucizumab safely and effectively reverse dabigatran in real-world patients requiring acute surgery, experiencing severe bleeding, or intoxication?
Observational (n=46)
Does idarucizumab safely and effectively reverse dabigatran in real-world patients requiring acute surgery, experiencing severe bleeding, or intoxication?
Real-world use of idarucizumab effectively and safely reverses dabigatran for acute surgery and severe bleeding without increasing short-term thromboembolic risk.
Hypothesis-generating for idarucizumab reversal in dabigatran emergencies; prospective trials needed before practice change.
AIMS: Idarucizumab reverses the anticoagulant effect of dabigatran. We aimed to investigate real-world experience with idarucizumab and associated clinical outcomes. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Haastrup et al. (2020) conducted an observational in Dabigatran users requiring reversal (n=46). Idarucizumab was evaluated on Clinical outcomes according to treatment indication and adverse events (bleeding, thrombosis or death) within 30 days. Idarucizumab effectively reversed dabigatran in real-world patients requiring acute surgery or with severe bleeding, with 83% survival and no thromboembolic complications at 30 days.
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