Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban

Neurological Research and Practice

Andreas Peter¹  Sebastian Hörber¹  Matthias Ebner²  Charlotte Spencer³  Maria-Ioanna Stefanou³  Ulf Ziemann³  Paula Bombach³  Johannes Tünnerhoff³  Florian Härtig³  Matthias Sonnleitner³  Annerose Mengel³  Sven Poli³  Joachim Kuhn⁴  Ingvild Birschmann⁴ 

[1] Department of Diagnostic Laboratory Medicine, Institue for Clinical Chemistry and Pathobiochemistry, Eberhard-Karls University Tübingen, Tübingen, Germany;Department of Nephrology and Medical Intensive Care, Charité University Medicine, Berlin, Germany;Department of Neurology & Stroke, University Hospital, Eberhard-Karls University Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany;Hertie Institute for Clinical Brain Research, Eberhard-Karls University Tübingen, Tübingen, Germany;Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University, Bad Oeynhausen, Germany;

关键词: Point-of-care testing;    POCT;    Direct oral anticoagulants;    DOAC;    Non-vitamin K antagonist oral anticoagulants;    NOAC;    Anticoagulation reversal;    Thrombolysis;    Stroke;   

DOI  :  10.1186/s42466-021-00105-4

来源: Springer

【 摘 要 】

BackgroundDirect oral anticoagulants (DOAC) including edoxaban are increasingly used for stroke prevention in atrial fibrillation. Despite treatment, annual stroke rate in these patients remains 1–2%. Rapid assessment of coagulation would be useful to guide thrombolysis or reversal therapy in this growing population of DOAC/edoxaban-treated stroke patients. Employing the Hemochron™ Signature Elite point-of-care test system (HC-POCT), clinically relevant plasma concentrations of dabigatran and rivaroxaban can be excluded in a blood sample. However, no data exists on the effect of edoxaban on HC-POCT results.We evaluated whether edoxaban plasma concentrations above the current treatment thresholds for thrombolysis or anticoagulation reversal (i.e., 30 and 50 ng/mL) can be ruled out with the HC-POCT.MethodsWe prospectively studied patients receiving a first dose of edoxaban. Six blood samples were collected from each patient: before, 0.5, 1, 2, 8, and 24 h after drug intake. HC-POCT-based INR (HC-INR), activated clotting time (HC-ACT+ and HC-ACT-LR), activated partial thromboplastin time (HC-aPTT), and mass spectrometry for edoxaban plasma concentrations were performed at each time-point. We calculated correlations, receiver operating characteristics (ROC) and test-specific cut-offs for ruling out edoxaban concentrations > 30 and > 50 ng/mL in a blood sample.ResultsOne hundred twenty blood samples from 20 edoxaban-treated patients were analyzed. Edoxaban plasma concentrations ranged from 0 to 512 ng/mL. HC-INR/HC-ACT+/HC-ACT-LR/HC-aPTT ranged from 0.7–8.3/78–310 s/65–215 s/19–93 s, and Pearson’s correlation coefficients showed moderate to very strong correlations with edoxaban concentrations (r = 0.95/0.79/0.70/0.60). With areas under the ROC curve of 0.997 (95% confidence interval: 0.991–0.971) and 0.989 (0.975–1.000), HC-INR most reliably ruled out edoxaban concentrations > 30 and > 50 ng/mL, respectively, and HC-INR results ≤1.5 and ≤ 2.1 provided specificity/sensitivity of 98.6% (91.2–99.9)/98.0% (88.0–99.9) and 96.8% (88.0–99.4)/96.5% (86.8–99.4).ConclusionsOur study represents the first systematic evaluation of the HC-POCT in edoxaban-treated patients. Applying sufficiently low assay-specific cut-offs, the HC-POCT may not only be used to reliably rule out dabigatran and rivaroxaban, but also very low edoxaban concentrations in a blood sample. Because the assay-specific cut-offs were retrospectively defined, further investigation is warranted.Trial registrationClinicalTrials.gov, registration number: NCT02825394, registered on: 07/07/2016, URL

【 授权许可】

CC BY