A single heparin-calibrated anti-Xa assay demonstrated a strong correlation (rs 0.97) with LC-MS/MS for measuring rivaroxaban, apixaban, and edoxaban concentrations and correctly predicted clinically relevant drug levels.
Cross-Sectional (n=845)
Blinded to reference standard
Yes
Does a single, heparin-calibrated anti-Xa assay accurately measure rivaroxaban, apixaban, and edoxaban drug concentrations compared to LC-MS/MS in patients treated with these DOACs?
A single, heparin-calibrated anti-Xa assay can accurately measure rivaroxaban, apixaban, and edoxaban plasma concentrations, potentially simplifying laboratory monitoring of DOACs.
Effect estimate: rs 0.97 (95% CI 0.97-0.98)
Background: Applying a single anti-Xa assay, calibrated to unfractionated heparin to measure rivaroxaban, apixaban, and edoxaban would simplify laboratory procedures and save healthcare costs. Aim: We hypothesized that a heparin-calibrated anti-Xa assay would accurately measure rivaroxaban, apixaban, and edoxaban drug concentrations and correctly predict clinically relevant drug levels. Methods: Heparin assay. Drug concentrations were determined using ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cut-off levels were determined in a derivation dataset (50% of patients) and sensitivities and specificities were calculated in a verification dataset (50% of patients). Results: . Specificities were 86.3% (79.2-91.7), 89.8% (84.5-93.7), and 88.7% (84.2-92.2), respectively. Conclusion: In a large prospective study in clinical practice, a strong correlation of heparin-calibrated anti-Xa measurements with LC-MS/MS results was observed and clinically relevant drug concentrations were predicted correctly.
Meihandoest et al. (Thu,) conducted a cross-sectional in Patients treated with direct oral anticoagulants (rivaroxaban, apixaban, or edoxaban) (n=845). Heparin-calibrated anti-Xa assay (Siemens INNOVANCE Heparin) vs. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was evaluated on Correlation between anti-Xa activity and drug concentrations as measured by LC-MS/MS (rs 0.97, 95% CI 0.97-0.98). A single heparin-calibrated anti-Xa assay demonstrated a strong correlation (rs 0.97) with LC-MS/MS for measuring rivaroxaban, apixaban, and edoxaban concentrations and correctly predicted clinically relevant drug levels.