Meihandoest, Tamana; Studt, Jan-Dirk; Mendez, Adriana; Alberio, Lorenzo; Fontana, Pierre; Wuillemin, Walter A; Schmidt, Adrian; Graf, Lukas; Gerber, Bernhard; Amstutz, Ursula; Bovet, Cedric; Sauter, Thomas C; Asmis, Lars M; Nagler, Michael (2022). Accuracy of a Single, Heparin-Calibrated Anti-Xa Assay for the Measurement of Rivaroxaban, Apixaban, and Edoxaban Drug Concentrations: A Prospective Cross-Sectional Study. Frontiers in cardiovascular medicine, 9, p. 817826. Frontiers 10.3389/fcvm.2022.817826
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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
This analysis is part of the Simple-Xa study, a prospective multicenter cross-sectional study conducted in clinical practice. Patients treated with rivaroxaban, apixaban, or edoxaban were included. Anti-Xa activity was measured using the Siemens INNOVANCE® 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
Overall, 845 patients were available for analysis. Correlation coefficients (r s ) between the heparin-calibrated anti-Xa assay and drug concentrations were 0.97 (95% CI 0.97, 0.98) for rivaroxaban, 0.96 (0.96, 0.97) for apixaban, and 0.96 (0.94, 0.99) for edoxaban. The area under the receiver operating characteristics curve (ROC) was 0.99 for all clinically relevant drug concentrations. In the verification dataset, the sensitivity was 94.2% (95% CI 90.8-96.6) for 30 μg L-1, 95.8% (92.4-98.0) for 50 μg L-1, and 98.7% (95.5-99.9) for 100 μg L-1. 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.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry 04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > University Emergency Center |
UniBE Contributor: |
Meihandoest, Tamana, Amstutz, Ursula, Bovet, Cédric, Sauter, Thomas Christian, Nagler, Michael |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2297-055X |
Publisher: |
Frontiers |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
05 Apr 2022 17:58 |
Last Modified: |
01 Jan 2023 02:02 |
Publisher DOI: |
10.3389/fcvm.2022.817826 |
PubMed ID: |
35369293 |
Uncontrolled Keywords: |
anti-Xa assay diagnostic accuracy direct oral anticoagulants laboratory monitoring rivaroxaban |
BORIS DOI: |
10.48350/169018 |
URI: |
https://boris.unibe.ch/id/eprint/169018 |
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