Abstract
BackgroundPoint-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. Specific POCT for direct oral anticoagulants (DOAC) is not available, but the effects of DOAC on established POCT have been described. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients.MethodsWe enrolled 68 patients receiving apixaban, rivaroxaban, or dabigatran and obtained blood samples at six pre-specified time points. Coagulation testing was performed using prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and activated clotting time (ACT+ and ACT-low range) POCT cards. For comparison, laboratory-based assays of diluted thrombin time (Hemoclot) and anti-Xa activity were conducted. DOAC concentrations were determined by liquid chromatography-tandem mass spectrometry.ResultsFour hundred and three samples were collected. POCT results of PT/INR and ACT+ correlated with both rivaroxaban and dabigatran concentrations. Insufficient correlation was found for apixaban. Rivaroxaban concentrations at <30 and <100 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.0 and ≤1.1 and ACT+ POCT ≤120 and ≤130 s. Dabigatran concentrations at <30 and <50 ng/mL were detected with >95% specificity at PT/INR POCT ≤1.1 and ≤1.2 and ACT+ POCT ≤100 s.ConclusionsHemochron® Signature POCT can be a fast and reliable alternative for guiding emergency treatment during rivaroxaban and dabigatran therapy. It allows the rapid identification of a relevant fraction of patients that can be treated immediately without the need to await the results of much slower laboratory-based coagulation tests.Trial registrationUnique identifier, NCT02371070. Retrospectively registered on 18 February 2015.
Highlights
Point-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment
In patients receiving vitamin K antagonists (VKA), point-of-care testing (POCT) of coagulation has proven its great value in accelerating emergency treatment [1]
Samples collected after direct oral anticoagulants (DOAC) intake contained a median concentration of 57.2 ng/mL apixaban (IQR 35.3–101.2, n = 97), 99.3 ng/mL rivaroxaban (IQR 25.7– 184.3, n = 98), and 29.0 ng/mL dabigatran (IQR 10.7– 72.3, n = 148)
Summary
Point-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients. Previous reports indicate that Hemochron® Signature is responsive to rivaroxaban and dabigatran [3,4,5,6,7] These reports aimed at quantitative measurements rather than qualitatively ruling out low but relevant DOAC concentrations, and used either artificially DOAC-spiked plasma samples [3, 4] or they only comprised a few samples with low DOAC concentrations [5,6,7]. The diagnostic value of Hemochron® Signature in guiding emergency treatment decisions in DOAC-treated patients has not been clarified
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