Point-of-care testing of coagulation in patients treated with edoxaban
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Point-of-care testing of coagulation in patients treated with edoxaban Florian Härtig1 · Ingvild Birschmann2 · Andreas Peter3 · Sebastian Hörber3 · Matthias Ebner4 · Matthias Sonnleitner1 · Charlotte Spencer1 · Paula Bombach1 · Maria‑Ioanna Stefanou1 · Joachim Kuhn2 · Annerose Mengel1 · Ulf Ziemann1 · Sven Poli1
© The Author(s) 2020
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 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 Point-of-care · CoaguChek · DOAC · Stroke · Thrombolysis · Anticoagulation reversal
Highlights • First study of point-of-care coagulation testing in edoxa-
ban-treated patients.
* Sven Poli sven.poli@uni‑tuebingen.de 1
Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, Eberhard-Karls University, Tübingen, Tübingen, Germany
2
Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany
3
Department for Diagnostic Laboratory Medicine, Institute for Clinical Chemistry and Pathobiochemistry, University Hospital Tuebingen, Tübingen, Germany
4
Department of Nephrology and Medical Intensive Care, Charité – University Medicine Berlin, Berlin, Germany
• Using a sufficiently low INR cut-off, the CoaguChek® is
able to safelyexclude edoxaban and rivaroxaban plasma concentrations above the guideline-endorsed thresholds of 30 and 50 ng/mL. • Thus, identification of thrombolysiseligible stroke p
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