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Assessment of the effect of direct oral anticoagulants dabigatran, rivaroxaban, and apixaban in healthy male volunteers using a thrombin generation assay.
Res Pract Thromb Haemost. 2017 Oct; 1(2):194-201.RP

Abstract

Background

There are clinical situations where monitoring direct oral anticoagulants (DOACs) may be useful. The clinical application of thrombin generation assay (TGA) in monitoring the effect of DOACs has not been well established. An ex vivo study was performed to systematically evaluate the anticoagulant effect of dabigatran, rivaroxaban and apixaban on each individual TGA parameter through serial measurements over time to assess suitability of these parameters for monitoring the anticoagulant effect of DOACs.

Methods

Ten healthy volunteers were given oral dabigatran 150 mg, rivaroxaban 20 mg, or apixaban 10 mg once. TGA parameters lag time, endogenous Thrombin potential (ETP), and thrombin peak height, time to peak, and velocity index were measured at times 0, 2, 4, and 24 hours after intake of DOAC. TGA parameters and DOAC concentrations were correlated.

Results

The lag time was significantly correlated with all DOAC concentrations (r ≥ .81, P < .0001 for all). Thrombin peak height best correlated with direct Factor Xa inhibitor (FXa) concentrations in nonlinear fashion (R² ≥ .87). ETP was weakly correlated with DOAC levels (r ≤ .68). Besides lag time, the other TGA parameters were not significantly altered over time by dabigatran.

Conclusion

Lag time was the only sensitive TGA parameter across the different classes of DOACs evaluated. Thrombin peak height was strongly correlated to FXa inhibitor concentrations and potentially a useful parameter to monitor FXa inhibitors at low concentrations. ETP had a weak correlation with achieved DOAC concentrations and is likely less suitable for assessment of DOAC effect as a stand-alone parameter.

Authors+Show Affiliations

St. Mary Heart and Vascular Center Essentia Health Duluth MN USA. Bispebjerg University Hospital University of Copenhagen Copenhagen Denmark.University of Minnesota Duluth MN USA.Diagnostica Stago Inc. Parsippany NJ USA.Bispebjerg University Hospital University of Copenhagen Copenhagen Denmark.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30046690

Citation

Artang, Ramin, et al. "Assessment of the Effect of Direct Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban in Healthy Male Volunteers Using a Thrombin Generation Assay." Research and Practice in Thrombosis and Haemostasis, vol. 1, no. 2, 2017, pp. 194-201.
Artang R, Anderson M, Riley P, et al. Assessment of the effect of direct oral anticoagulants dabigatran, rivaroxaban, and apixaban in healthy male volunteers using a thrombin generation assay. Res Pract Thromb Haemost. 2017;1(2):194-201.
Artang, R., Anderson, M., Riley, P., & Nielsen, J. D. (2017). Assessment of the effect of direct oral anticoagulants dabigatran, rivaroxaban, and apixaban in healthy male volunteers using a thrombin generation assay. Research and Practice in Thrombosis and Haemostasis, 1(2), 194-201. https://doi.org/10.1002/rth2.12044
Artang R, et al. Assessment of the Effect of Direct Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban in Healthy Male Volunteers Using a Thrombin Generation Assay. Res Pract Thromb Haemost. 2017;1(2):194-201. PubMed PMID: 30046690.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of the effect of direct oral anticoagulants dabigatran, rivaroxaban, and apixaban in healthy male volunteers using a thrombin generation assay. AU - Artang,Ramin, AU - Anderson,Maren, AU - Riley,Paul, AU - Nielsen,Jorn D, Y1 - 2017/09/19/ PY - 2017/02/02/received PY - 2017/08/01/accepted PY - 2018/7/27/entrez PY - 2018/7/27/pubmed PY - 2018/7/27/medline KW - apixaban KW - dabigatran KW - direct oral anticoagulants KW - rivaroxaban KW - thrombin generation assay SP - 194 EP - 201 JF - Research and practice in thrombosis and haemostasis JO - Res Pract Thromb Haemost VL - 1 IS - 2 N2 - Background: There are clinical situations where monitoring direct oral anticoagulants (DOACs) may be useful. The clinical application of thrombin generation assay (TGA) in monitoring the effect of DOACs has not been well established. An ex vivo study was performed to systematically evaluate the anticoagulant effect of dabigatran, rivaroxaban and apixaban on each individual TGA parameter through serial measurements over time to assess suitability of these parameters for monitoring the anticoagulant effect of DOACs. Methods: Ten healthy volunteers were given oral dabigatran 150 mg, rivaroxaban 20 mg, or apixaban 10 mg once. TGA parameters lag time, endogenous Thrombin potential (ETP), and thrombin peak height, time to peak, and velocity index were measured at times 0, 2, 4, and 24 hours after intake of DOAC. TGA parameters and DOAC concentrations were correlated. Results: The lag time was significantly correlated with all DOAC concentrations (r ≥ .81, P < .0001 for all). Thrombin peak height best correlated with direct Factor Xa inhibitor (FXa) concentrations in nonlinear fashion (R² ≥ .87). ETP was weakly correlated with DOAC levels (r ≤ .68). Besides lag time, the other TGA parameters were not significantly altered over time by dabigatran. Conclusion: Lag time was the only sensitive TGA parameter across the different classes of DOACs evaluated. Thrombin peak height was strongly correlated to FXa inhibitor concentrations and potentially a useful parameter to monitor FXa inhibitors at low concentrations. ETP had a weak correlation with achieved DOAC concentrations and is likely less suitable for assessment of DOAC effect as a stand-alone parameter. SN - 2475-0379 UR - https://www.unboundmedicine.com/medline/citation/30046690/Assessment_of_the_effect_of_direct_oral_anticoagulants_dabigatran_rivaroxaban_and_apixaban_in_healthy_male_volunteers_using_a_thrombin_generation_assay_ L2 - https://doi.org/10.1002/rth2.12044 DB - PRIME DP - Unbound Medicine ER -
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