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Open Access
CC BY 4.0 · TH Open 2021; 05(04): e570-e576
DOI: 10.1055/a-1692-1415
Original Article

Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography

Authors

  • Ramin Artang 

    1   Essentia Health St. Mary's Heart and Vascular Center, Duluth, Minnesota, United States
    2   Bispebjerg University of Copenhagen Hospital, Department of Cardiology, Copenhagen, Denmark

  • Joao D. Dias

    3   Haemonetics Corp., Braintree, Massachusetts, United States

  • Mark Walsh

    4   Memorial Hospital of South Bend, Department of Energy Medicine, Sound Bend, Indiana, United States

  • Kevin Bliden

    5   Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United States

  • Jorn D. Nielsen

    2   Bispebjerg University of Copenhagen Hospital, Department of Cardiology, Copenhagen, Denmark

  • Maren Anderson

    6   University of Minnesota School of Medicine, Duluth, Minnesota, United States

  • Brian C. Thurston

    7   Spartanburg Regional Medical Center, Division of Surgery, Spartanburg, South Carolina, United States

  • Udaya S. Tantry

    5   Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United States

  • Jan Hartmann

    3   Haemonetics Corp., Braintree, Massachusetts, United States

  • Paul A. Gurbel 

    5   Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Funding This study was funded by the Haemonetics Corporation.
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Abstract

Background Direct-acting oral anticoagulants (DOACs) do not require monitoring. Measurement of DOAC effect would be useful in the event of bleeding, trauma, and thromboembolism while on anticoagulation. We evaluated the effectiveness of the investigational DOAC assays on the TEG®6s Hemostasis Analyzer to assess the anticoagulant effect of DOACs in patients treated for atrial fibrillation or deep vein thrombosis (DVT).

Methods Patients on treatment for a minimum of 7 days with standard doses of dabigatran, rivaroxaban, and apixaban were included. DOAC plasma concentrations and TEG®6s Reaction (R)-time were measured and correlated. The sensitivity, specificity, and negative predictive value (NPV) of R-time to detect DOAC concentrations of ≥30, ≥50, and ≥100 ng/mL were calculated.

Results A total of 189 patients were included, (n = 50) on apixaban, (n = 62) on rivaroxaban, (n = 53) on dabigatran, and (n = 24) on no DOAC were studied. Using the direct thrombin inhibitor (DTI) channel, R-time demonstrated strong linear correlation with dabigatran levels (r = 0.93, p < 0.0001). Using the antifactor Xa (AFXa) channel, R-time demonstrated strong nonlinear correlation with rivaroxaban and apixaban levels (r s = 0.92 and 0.84, respectively, p < 0.0001 for both). R-time revealed strong sensitivity and NPV in detecting low DOAC levels for the predefined concentrations.

Conclusion R-time measured by TEG®6s DOAC-specific cartridge has a strong correlation with concentrations of the most commonly used DOACs with high sensitivity and NPV for detecting lower drug levels that are considered clinically relevant for patients in need of antidote, or prior to urgent surgery. Further studies to determine the relation of R-time to clinical outcomes are warranted.

Keywords

clinical trials: oral anticoagulants - coagulation inhibitors - diagnosis management - apixaban - rivaroxaban - dabigatran

Authors' Contributions

R.A. and J.H. conceived and designed the study. M.W., K.B., B.C.T., M.A., J.D.N., and P.A.G. contributed to data collection and interpretation. All authors revised the article for important intellectual content and approved the final version for submission.


Conflict of Interests

J.D.D. and J.H. were employees of Haemonetics Corporation at the time of the study. This study was supported by Haemonetics Corporation (Boston, Massachusetts, United States). The other authors have no other relevant financial interest in the products or companies described in this article.




Publikationsverlauf

Eingereicht: 25. März 2021

Angenommen: 04. November 2021

Accepted Manuscript online:
09. November 2021

Artikel online veröffentlicht:
30. Dezember 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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