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

R. Bavalia*, R. Abdoellakhan, H.J.M. Brinkman, M.P.A. Brekelmans, E.N. Hamulyak, M. Zuurveld, B.A. Hutten, P.E. Westerweel, R.H. Olie, H. ten Cate, M. Kruip, S. Middeldorp, K. Meijer, M. Coppens

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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 - 1 May 2020

Keywords

  • apixaban
  • atrial-fibrillation
  • dabigatran
  • emergencies
  • factor xa inhibitors
  • hemorrhage
  • idarucizumab
  • prothrombin complex concentrates
  • reversal
  • rivaroxaban
  • safety
  • thrombin generation
  • vitamin-k antagonists
  • warfarin
  • SAFETY
  • RIVAROXABAN
  • APIXABAN
  • THROMBIN GENERATION
  • VITAMIN-K ANTAGONISTS
  • FACTOR XA INHIBITORS
  • ATRIAL-FIBRILLATION
  • REVERSAL
  • DABIGATRAN
  • WARFARIN
  • factor Xa inhibitors

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