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Concomitant assessment of rivaroxaban concentration and its impact on thrombin generation

Saartje Bloemen1, Suzanne Zwaveling1, François Mullier2

  • 1Department of Biochemistry, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, the Netherlands.

Thrombosis Research
|November 3, 2019
PubMed
Abstract

Insights

A new assay, Xross-CAT, accurately measures direct oral anticoagulant (DOAC) levels and their impact on coagulation. This method provides a comprehensive view of a patient's anticoagulation status, crucial for managing bleeding or thrombotic risks.

Area of Science:

  • Pharmacology
  • Clinical Chemistry
  • Hematology

Background:

  • Direct oral anticoagulants (DOACs) require reliable assays for measuring drug levels and activity, especially in critical situations.
  • Plasma drug concentrations alone do not fully represent the anticoagulant effect in individuals.
  • A novel technique was developed to assess both rivaroxaban plasma concentrations and its global effect on coagulation.

Purpose of the Study:

  • To evaluate the novel Xross-CAT assay for measuring rivaroxaban concentrations and its anticoagulant activity.
  • To validate Xross-CAT against established methods for rivaroxaban level determination.
  • To assess the correlation between rivaroxaban levels and its impact on thrombin generation and other coagulation parameters.

Main Methods:

  • Rivaroxaban concentrations and coagulation activity were measured in 50 patients using the Xross-CAT assay.
  • Thrombin generation (TG) in platelet-poor plasma was used to assess anticoagulant effect with 5 pM tissue factor.
  • Assay validation was performed against the Biophen DiXaI assay, with Prothrombin Time (PT) and dilute Russell viper venom time (dRVVT) also measured.

Main Results:

  • The Xross-CAT assay demonstrated variability below 12% and strong correlation with Biophen DiXaI (rs = 0.885).
  • Bland-Altman analysis showed a bias of 4.9%, with a Passing-Bablok equation of y = 1.1x - 2.1.
  • Moderate correlations were observed between plasma levels and thrombin generation (ETP rs = -0.548; Peak rs = -0.559), and with PT (rs = 0.739) and dRVVT (rs = 0.692).

Conclusions:

  • Xross-CAT is a reliable assay for rivaroxaban levels, correlating well with the validated Biophen DiXaI.
  • Clinical complications like bleeding or thrombosis are not solely determined by drug levels and can be influenced by other risk factors.
  • The key advantage of Xross-CAT is its simultaneous measurement with thrombin generation, offering a comprehensive overview of a patient's anticoagulation status relative to DOAC levels.
Keywords:
Coagulation assaysDirect factor Xa inhibitorPlasma concentrationsRivaroxabanThrombin generation

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