Matthias Ebner1, Andreas Peter1, Charlotte Spencer1, Florian Härtig1, Ingvild Birschmann1, Joachim Kuhn1, Martin Wolf1, Natalie Winter1, Francesca Russo1, Christine S Zuern1, Gunnar Blumenstock1, Ulf Ziemann1, Sven Poli2. 1. 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.). 2. 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.
Abstract
BACKGROUND AND PURPOSE: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02371044.
BACKGROUND AND PURPOSE: 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 strokepatients 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02371044.
Authors: Fadiea Al-Aieshy; Rickard E Malmström; Jovan Antovic; Anton Pohanka; Yuko Rönquist-Nii; Maria Berndtsson; Faris Al-Khalili; Mika Skeppholm Journal: Eur J Clin Pharmacol Date: 2016-04-11 Impact factor: 2.953
Authors: Florian Härtig; Ingvild Birschmann; Andreas Peter; Matthias Ebner; Charlotte Spencer; Michael Gramlich; Hardy Richter; Joachim Kuhn; Rainer Lehmann; Gunnar Blumenstock; Christine S Zuern; Ulf Ziemann; Sven Poli Journal: Thromb Haemost Date: 2021-01-14 Impact factor: 5.249
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Authors: David J Seiffge; Christopher Traenka; Alexandros A Polymeris; Sebastian Thilemann; Benjamin Wagner; Lisa Hert; Mandy D Müller; Henrik Gensicke; Nils Peters; Christian H Nickel; Christoph Stippich; Raoul Sutter; Stephan Marsch; Urs Fisch; Raphael Guzman; Gian Marco De Marchis; Philippe A Lyrer; Leo H Bonati; Dimitrios A Tsakiris; Stefan T Engelter Journal: J Stroke Date: 2017-09-06 Impact factor: 6.967
Authors: Matthias Ebner; Ingvild Birschmann; Andreas Peter; Charlotte Spencer; Florian Härtig; Joachim Kuhn; Gunnar Blumenstock; Christine S Zuern; Ulf Ziemann; Sven Poli Journal: Crit Care Date: 2017-02-15 Impact factor: 9.097