Key result
CoaguChek-INR point-of-care testing strongly correlated with edoxaban concentrations (r=0.73) and safely excluded clinically relevant levels (>30 ng/mL) with >95% specificity.
Why the study?
Rapid exclusion of relevant anticoagulation is necessary to guide thrombolysis or reversal therapy, but no data existed on the effect of edoxaban on available point-of-care test systems.
Does CoaguChek-INR point-of-care testing accurately rule out clinically relevant edoxaban concentrations in ischemic stroke patients?
Observational (n=20)
Partially blinded
No
Does CoaguChek-INR point-of-care testing accurately rule out clinically relevant edoxaban concentrations in ischemic stroke patients?
Effect estimate: r = 0.73
p-value: p=<0.001
CoaguChek-INR point-of-care testing can safely and rapidly exclude clinically relevant edoxaban concentrations to guide emergency thrombolysis or reversal therapy in stroke patients.
May support rapid exclusion of high edoxaban levels in stroke; leaves open prospective validation before guiding thrombolysis or reversal.
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.
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Härtig et al. (2020) conducted an observational in Ischemic stroke (n=20). CoaguChek-INR point-of-care testing vs. UPLC-MS/MS (gold standard) was evaluated on Correlation between CC-INR and edoxaban plasma concentrations (r = 0.73, p=<0.001). CoaguChek-INR point-of-care testing strongly correlated with edoxaban concentrations (r=0.73) and safely excluded clinically relevant levels (>30 ng/mL) with >95% specificity.
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