Emergencies on direct oral anticoagulants: Management, outcomes, and laboratory effects of prothrombin complex concentrate

Roisin Bavalia*, Rahat Abdoellakhan, Herm Jan M. Brinkman, Marjolein P.A. Brekelmans, Eva N. Hamulyák, Marleen Zuurveld, Barbara A. Hutten, Peter E. Westerweel, Renske H. Olie, Hugo ten Cate, Marieke Kruip, Saskia Middeldorp, Karina Meijer, Michiel Coppens

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

18 Citations (Scopus)
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Abstract

Background: In the initial absence of specific reversal agents for factor Xa inhibitors (FXa-Is), prothrombin complex concentrate (PCC) as a hemostatic agent has been recommended by guidelines. Since 2017, idarucizumab has been registered for dabigatran reversal. Still, data on the clinical outcome of direct oral anticoagulant (DOAC)-related emergencies (major bleeding or urgent interventions) is scarce. In addition, it is unknown to what extent PCC restores thrombin generation in FXa-I–related emergencies. Our aim was to describe management and clinical outcomes of DOAC-related emergencies and to assess the laboratory effect of PCC in patients with FXa-I emergencies. Methods: In this prospective cohort study in 5 Dutch hospitals, patients presenting with DOAC-related emergencies were eligible. The primary outcome was effective hemostasis according to the ISTH definition. Safety outcomes were 30-day mortality and thromboembolic rate. In patients treated with PCC, additional blood samples were taken to assess the effect on thrombin generation. Results: We included 101 patients with major bleeding (FXa-I, 76; dabigatran, 25) and 21 patients requiring an urgent intervention (FXa-I, 16; dabigatran, 5). Of patients with major bleeding, 67% were treated with PCC or idarucizumab. Effective hemostasis, 30-day mortality, and thromboembolism rate were 67%, 22%, and 1%, respectively. In a subset of bleeding patients on FXa-I managed with PCC, thrombin generation increased, with 96% immediately after PCC administration. In patients requiring an urgent intervention, effective hemostasis, 30-day mortality, and thromboembolic rate were 95%, 14%, and 5%. Conclusions: Effective hemostasis was achieved in the majority of patients presenting with DOAC-related emergencies;, thromboembolic complications were rare, and mortality was quite high.

Original languageEnglish
Pages (from-to)569-581
Number of pages13
JournalResearch and Practice in Thrombosis and Haemostasis
Volume4
Issue number4
DOIs
Publication statusPublished - May 2020

Bibliographical note

Funding Information:
The study was funded by ZonMw (Grant No. 836021017). Sanquin Blood Supply and Daiichi Sankyo provided additional financial support for conducting the study. The sponsor had no influence on the study design or conduct, the collection and analyses of data, and the final manuscript writing and approval.

Publisher Copyright:
© 2020 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals, Inc on behalf of International Society on Thrombosis and Haemostasis.

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