Diagnostic accuracy of thromboelastometry and its correlation with the HPLC-MS/MS quantification test

Area of Science:

• Pharmacology
• Clinical Diagnostics
• Hemostasis

Background:

• Rivaroxaban is a widely used anticoagulant.
• Accurate monitoring of rivaroxaban plasma concentrations is crucial for optimizing therapeutic efficacy and minimizing bleeding risk.
• Traditional methods for drug monitoring can be time-consuming and complex.

Purpose of the Study:

• To evaluate the diagnostic accuracy of thromboelastometry in assessing rivaroxaban plasma concentrations.
• To compare thromboelastometry with high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), the gold standard for drug monitoring.
• To explore the potential of thromboelastometry as a screening tool for rivaroxaban-related bleeding risk.

Main Methods:

• Forty-six patients receiving rivaroxaban (10-20 mg once daily or 15 mg twice daily) were studied.
• Rivaroxaban plasma concentrations were measured using HPLC-MS/MS at peak and trough times.
• Thromboelastometry was performed using a ROTEM® delta analyzer.

Main Results:

• Significant prolongations in clotting time (CT) were observed with increasing rivaroxaban doses.
• Positive correlations were found between rivaroxaban concentration and CT/clot formation time at peak levels.
• Negative correlations were observed between rivaroxaban concentration and alpha angle/amplitude parameters.
• CT demonstrated high specificity and sensitivity for detecting elevated rivaroxaban levels.

Conclusions:

• Thromboelastometry shows diagnostic accuracy in assessing rivaroxaban concentrations.
• The ROTEM® system has potential as a rapid screening tool for monitoring rivaroxaban levels.
• This method may aid in assessing the bleeding risk associated with rivaroxaban therapy.