![]() This was done in order to cover a wide range of edoxaban concentrations. Six blood samples were collected from each subject via a venous catheter or by direct venipuncture before first intake of edoxaban, and 0.5, 1, 2, and 8 h after intake, and at trough (24 h). Sample collection and coagulation testing Use of anti-platelet drugs was permitted. Patients with either abnormal coagulation values at baseline (INR > 1.2 or activated partial thromboplastin time (aPTT) > 40 s), or history of coagulopathy were also excluded. Subjects who had received VKA or DOAC within 14 days, low-molecular-weight heparin within 24 h, or unfractionated heparin within 12 h before first DOAC intake were excluded to rule out interference with measurements. We enrolled ischemic stroke patients receiving a first dose of edoxaban for secondary prevention of thromboembolism. The study was conducted at the Department of Neurology of Tübingen University Hospital, a tertiary care facility in Germany. Written informed consent was obtained from all patients before enrollment. The Clinical Trial Registration Information unique identifier for the study is NCT02825394. Independent review board approval was obtained prior to all study-related activity from the ethics committee of Tübingen University Hospital (Protocol No. Single-center, prospective diagnostic study with partially blinded outcome assessment. In analogy to our previous research conducted with apixaban, dabigatran, and rivaroxaban, we aimed to determine whether the commercially available prothrombin time (PT)/international normalized ratio (INR)-based CoaguChek® (CC)-POCT (Roche Diagnostics, Rotkreuz, Switzerland) allows for ruling out low but clinically relevant edoxaban plasma concentrations in a blood sample. Unfortunately, these assays are not available on any commercial point-of-care test device (POCT), and laboratory-based coagulation testing clearly limits emergency decision making due to their long turnaround-times. (Calibrated) anti-Xa activity assays (AXA) are recommended by guidelines as state-of-the-art for coagulation assessment during edoxaban therapy. In these situations, DOAC-mediated anticoagulation needs to be excluded prior to initiation of thrombolysis or in order to avoid unnecessary administration of expensive and potentially pro-thrombotic reversal therapy. Annual risk for ischemic stroke in edoxaban-treated patients with atrial fibrillation, however, remains above 1%, and ~ 0.4% for intracranial hemorrhage. Similar to the other DOAC, edoxaban has gained approval by providing comparable efficacy and improved safety. CC-POCT is suitable to safely exclude clinically relevant edoxaban concentrations prior to thrombolysis, or guide reversal therapy in stroke patients.Īlongside other direct oral anticoagulants (DOAC), edoxaban is increasingly replacing vitamin K antagonists (VKA) for treatment and prevention of thrombosis and thromboembolism including ischemic stroke. Our study represents the first evaluation of coagulation-POCT in edoxaban-treated patients. 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. One hundred and twenty blood samples from 20 patients contained 0–302 ng/mL of edoxaban. CC-INR and mass spectrometry for edoxaban concentrations were performed for each time-point. 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). We studied patients receiving a first dose of edoxaban excluding subjects receiving other anticoagulants. 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. 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). ![]() Despite DOAC therapy, however, annual stroke rate in patients with atrial fibrillation remains 1–2%. Edoxaban, alongside other direct oral anticoagulants (DOAC), is increasingly used for prevention of thromboembolism, including stroke.
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