Point-of-care testing of coagulation in patients treated with edoxaban

J Thromb Thrombolysis. 2020 Oct;50(3):632-639. doi: 10.1007/s11239-020-02143-2.

Abstract

Edoxaban, alongside other direct oral anticoagulants (DOAC), is increasingly used for prevention of thromboembolism, including stroke. Despite DOAC therapy, however, annual stroke rate in patients with atrial fibrillation remains 1-2%. Rapid exclusion of relevant anticoagulation is necessary to guide thrombolysis or reversal therapy but, so far, no data exists on the effect of edoxaban on available point-of-care test systems (POCT). To complete our previous investigation on global coagulation-POCT for the detection of DOAC, we evaluated whether CoaguChek®-INR (CC-INR) is capable of safely ruling out edoxaban concentrations above the current treatment thresholds of 30/50 ng/mL in a blood sample. We studied patients receiving a first dose of edoxaban; excluding subjects receiving other anticoagulants. Six blood samples were collected from each patient: before drug intake, 0.5, 1, 2 and 8 h after intake, and at trough (24 h). CC-INR and mass spectrometry for edoxaban concentrations were performed for each time-point. One hundred and twenty blood samples from 20 patients contained 0-302 ng/mL of edoxaban. CC-INR ranged from 0.9 to 2.3. Pearson's correlation coefficient showed strong correlation between CC-INR and edoxaban concentrations (r = 0.73, p < 0.001). Edoxaban concentrations > 30 and > 50 ng/mL were ruled out by CC-INR ≤ 1.0 and ≤ 1.1, respectively, with high specificity (> 95%), and a sensitivity of 44% (95%-confidence interval: 30-59%) and 86% (74-93%), respectively. Our study represents the first evaluation of coagulation-POCT in edoxaban-treated patients. CC-POCT is suitable to safely exclude clinically relevant edoxaban concentrations prior to thrombolysis, or guide reversal therapy in stroke patients.

Keywords: Anticoagulation reversal; CoaguChek; DOAC; Point-of-care; Stroke; Thrombolysis.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Atrial Fibrillation / drug therapy
  • Blood Coagulation / drug effects*
  • Blood Coagulation Tests
  • Drug Monitoring
  • Factor Xa Inhibitors / blood
  • Factor Xa Inhibitors / pharmacology
  • Factor Xa Inhibitors / therapeutic use*
  • Female
  • Humans
  • International Normalized Ratio
  • Male
  • Middle Aged
  • Point-of-Care Testing
  • Prospective Studies
  • Pyridines / blood
  • Pyridines / pharmacology
  • Pyridines / therapeutic use*
  • Stroke / drug therapy
  • Thiazoles / blood
  • Thiazoles / pharmacology
  • Thiazoles / therapeutic use*

Substances

  • Factor Xa Inhibitors
  • Pyridines
  • Thiazoles
  • edoxaban