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Real world use of idarucizumab for dabigatran reversal in Aragón (Spain)


Journal of Cardiology & Current Research
Olga Gavín,1 José Manuel Calvo,2 Manuela Dobón-Rebollo,1 Irene Amarilla,1 Nuria Fernández,2 Luis Ignacio Sancho,1 Isabel Cuesta,3 Marta Villalba,2 Pedro Paul,4 Esther Franco-García,5 Ángeles Pérez,6 Laura Lacalle7

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Abstract

Background: Idarucizumab is the only reversal agent specifically targeting dabigatran anticoagulation effect. Real-world evidence for idarucizumab in Spain is limited. 
 
Objectives: To assess idarucizumab management and results according to the routine clinical practice in emergency situations in Aragon (Spain).
 
Methods: Observational, retrospective, multicentre study in Aragon (Spain). All patients that received idarucizumab (January 2016 - October 2019) for urgent reversal (major bleeding or emergency surgery) were included. Reversal effect was based on the activated Partial Thromboplastin Time (aPTT) in the first 24h.
 
Results: During the study period, thirty patients needed idarucizumab reversal in Aragon: 22 (73.3%) emergency surgeries, 7 (23.3%) major bleedings and 1 off-label use. Most patients were male (63.3%), aged (70.0% ≥75y-o) and showed mild/moderate renal function (80.0%). A high proportion of patients (66.7%) used dabigatran 110 mg (twice daily). Complete reversal (aPTT ≤40 seconds) was shown in 70.0% of the patients (85.7% major bleeding; 63.6% emergency surgery). Haemostasis was restored mainly in aged patients (81% in patients ≥75y-o), female (81.8%) and dabigatran reduced dose users (75.0%). Adverse events were shown in two patients (6.7%), none of them thrombosis-related. Since no thromboembolism was shown, according to clinical criteria, all patients could be considered as successfully reverted.
 
Conclusions: Idarucizumab demonstrated effective reversal of dabigatran in ≥70% of the emergency situations linked to anticoagulation reversal need in Aragon (Spain). The clinical use of idarucizumab was safe and conducted according to the authorized label, although it would be recommendable the development of standardized hospital protocols to guarantee an optimal drug use.
 

Keywords

anticoagulant drugs, antidotes, therapeutic use, evidence-based practice, aPTT, activated partial thromboplastin time, PT, prothrombin time, SD, standard deviation, AEMPS, agencia española de medicamentosy productos sanitarios, DOACs, direct oral anticoagulants, VKAs, vitamin K antagonists

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