Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants.
OBJECTIVE
Specific coagulation assays for non-vitamin K antagonist oral anticoagulants (NOAC) are relatively slow and often lack availability. Although specific point-of-care tests (POCT) are currently not available, NOAC are known to affect established coagulation POCT. This study aimed at determining the diagnostic accuracy of the CoaguChek POCT to rule out relevant concentrations of rivaroxaban, apixaban, and dabigatran in real-life patients.


METHODS
We consecutively enrolled 60 ischemic stroke patients newly started on NOAC treatment and obtained blood samples at 6 prespecified time points. Samples were tested using the CoaguChek POCT, laboratory-based coagulation assays (prothrombin time and activated partial thromboplastin time, anti-Xa test and Hemoclot), and liquid chromatography-tandem mass spectrometry for direct determination of NOAC concentrations.


RESULTS
Three hundred fifty-six blood samples were collected. The CoaguChek POCT strongly correlated (r=0.82 P<0.001) with rivaroxaban concentrations but did not accurately detect dabigatran or apixaban. If used to estimate the presence of low rivaroxaban concentrations, POCT was superior to predictions based on normal prothrombin time and activated partial thromboplastin time values even if sensitive reagents were used. POCT-results≤1.0 predicted rivaroxaban concentrations<32 and <100 ng/mL with a specificity of 90% and 96%, respectively.


CONCLUSIONS
If anti-Xa test is not available, we propose the use of the CoaguChek POCT to guide thrombolysis decisions after individual risk assessment in rivaroxaban-treated patients having acute ischemic stroke.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02371044.
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Matthias
M
Ebner
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Andreas
A
Peter
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Charlotte
C
Spencer
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Florian
F
Härtig
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Ingvild
I
Birschmann
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Joachim
J
Kuhn
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Martin
M
Wolf
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Natalie
N
Winter
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Francesca
F
Russo
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Christine S
CS
Zuern
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Gunnar
G
Blumenstock
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.).
Ulf
U
Ziemann
From the Department of Neurology and Stroke, and Hertie Institute for Clinical Brain Research (M.E., C.S., F.H., M.W., N.W., F.R., U.Z., S.P.), Division of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine IV (A.P.), Department of Cardiology and Cardiovascular Medicine (C.S.Z.), and Department of Clinical Epidemiology and Applied Biometry (G.B.), University of Tübingen, Tübingen, Germany; and Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Bad Oeynhausen, Ruhr University, Bochum, Germany (I.B., J.K.). sven.poli@uni-tuebingen.de.
Sven
S
Poli
D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000097:blood / Q000627:therapeutic use*; D000069604:Dabigatran / Q000097:blood / Q000627:therapeutic use; D065427:Factor Xa Inhibitors / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000067716:Point-of-Care Testing; D011720:Pyrazoles / Q000097:blood / Q000627:therapeutic use; D011728:Pyridones / Q000097:blood / Q000627:therapeutic use; D000069552:Rivaroxaban / Q000097:blood / Q000627:therapeutic use; D020521:Stroke / Q000517:prevention & control*
D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D000069552:Rivaroxaban; D000069604:Dabigatran
apixaban; dabigatran; rivaroxaban; stroke; thrombolytic therapy