Abstract
There are no clear and consistent guidelines on how to utilize DOAC assays, and reports on the use of DOAC levels in clinical practice is limited. The objective of this study was to analyze why DOAC levels are ordered, how the results affect clinical decision-making, and to determine if DOAC assays are utilized appropriately. This was a retrospective chart review study analyzing 150 dabigatran, rivaroxaban, and apixaban levels performed at a single institution. The majority of DOAC assays were ordered in situations or special patient populations where confirming absence or detecting presence of drug may be useful. The most common indication for ordering assays was prior to an invasive procedure. Most DOAC levels were timed appropriately but peak levels were most likely to be incorrectly ordered. Clinical decisions following level results depended on indication for ordering and were most commonly used to determine whether or not to proceed with an invasive procedure. The results of our study suggest while DOAC assays are generally ordered for useful indications, there is still a lack of understanding of when levels should be drawn and how to interpret DOAC assay results.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Barnes GD, Lucas E, Alexander GC, Goldberger ZD (2015) National trends in ambulatory oral anticoagulant use. Am J Med 128:1300–1305
Cuker A, Siegal D (2015) Monitoring and reversal of direct oral anticoagulant. Hematology 2015:117–124
Samuelson B, Cuker A, Siegal D, Crowther M, Garcia DA (2017) Laboratory assessment of the anticoagulant activity of direct oral anticoagulants. Chest 151:127–138
Adcock DM, Gosselin R (2015) Direct oral anticoagulants in the laboratory: 2015 review. Thromb Res 136:7–12
Mueck W, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, Kalebo P, Muelhofer E, Misselwitz F, Eriksson BI (2008) Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 100:453–461
Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A (2008) A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein DVT Dose Ranging Study. Blood 112:2242–2247
van Ryn J, Stangler J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, Clemens A (2010) Dabigatran etexilate—a novel reversible oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 103:1116–1127
Eliquis - Summary of Product Characteristics (2017) http://www.ema.europa.eu/docs/ en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf. Accessed 24 Aug 2017
Wright C, Brown R, Cuker A (2017) Laboratory measurement of the direct oral anticoagulants: indications and impact on management in clinical practice. Int J Lab Hematol 39:31–36
Martin K, Moll S (2016) Direct oral anticoagulant drug level testing in clinical practice: a single institution experience. Thromb Res 143:40–44
Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M (2012) Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial. Circulation 126:343–348
Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC (2014) Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation 129:1850–1859
Garcia D, Alexander JH, Wallentin L, Wojdyla DM, Thomas L, Hanna M, Al-Khatib SM, Dorian P, Ansell J, Commerford P, Flaker G, Lanas F, Vinereanu D, Xavier D, Hylek EM, Held C, Verheugt FW, Granger CB, Lopes RD (2014) Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures. Blood 124:3692–3698
Tripodi A (2016) To measure or not to measure direct oral anticoagulants before surgery or invasive procedures. J Thromb Haemost 14:1325–1327
Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD (2016) To measure or not to measure direct oral anticoagulants before surgery or invasive procedures: comment. J Thromb Haemost 14:2556–2559
Levy JH, Ageno W, Chan NC, Crowther M, Verhamme P, Weitz JI (2016) The subcommittee on control of anticoagulation. When and how to use antidotes for the reversal of direct oral anticoagulants: guidance from the SSC of the ISTH. J Thromb Haemost 14:623–627
Acknowledgements
We would like to acknowledge Ann K. Wittkowsky, PharmD, CACP, FASHP, FCCP, retired Director of Anticoagulation Services at University of Washington Medical Center for her thoughtful comments and help with earlier versions of this manuscript.
Author information
Authors and Affiliations
Contributions
TMG, DAG, and DES designed the study. TMG generated the data. TMG, DAG, and DES interpreted the results. TMG drafted the manuscript. DAG and DES critically revised the manuscript.
Corresponding author
Ethics declarations
Conflict of interest
T. M. Gu and D. E. Sabath declare they have no conflict of interests. D. A. Garcia has received research support from Daiichi Sankyo and consulting fees from Janssen.
Ethical approval
This was a retrospective study approved by the institutional review board at University of Washington Medicine. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent
For this type of study formal consent is not required.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Supplementary Fig. 1
Clinical decisions following assay results in the setting of acute hemorrhage. The following decisions refer to changes made at discharge: restarted DOAC, discontinued DOAC, and switched anticoagulant. (TIFF 1142 KB)
Supplementary Fig. 2
Clinical decisions following assay results in the setting of acute thrombosis. (TIFF 1142 KB)
Supplementary Fig. 3
Clinical decisions following assay results for drug interaction or renal impairment. (TIFF 1142 KB)
Rights and permissions
About this article
Cite this article
Gu, T.M., Garcia, D.A. & Sabath, D.E. Assessment of direct oral anticoagulant assay use in clinical practice. J Thromb Thrombolysis 47, 403–408 (2019). https://doi.org/10.1007/s11239-018-1793-0
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11239-018-1793-0