Key result
Anti-Xa activity calibrated by rivaroxaban demonstrated a sensitivity of 0.98 (95% CI 0.91-0.99) and specificity of 0.98 for detecting direct oral anticoagulant concentration at a 30 ng/mL threshold.
Why the study?
Different coagulation indices for DOACs exist in clinical practice, but limited data are available regarding their diagnostic power.
Do specific coagulation indices accurately determine direct oral anticoagulant concentrations compared to liquid chromatography/tandem mass spectrometry?
Meta-Analysis
Do specific coagulation indices accurately determine direct oral anticoagulant concentrations compared to liquid chromatography/tandem mass spectrometry?
DOAC-specific calibrated anti-Xa activity is a highly sensitive and specific index for rivaroxaban concentration, while diluted thrombin time has high specificity but moderate sensitivity for dabigatran.
INTRODUCTION: Different coagulation indices for direct oral anticoagulants (DOACs) exist in clinical practice, but limited data are available for the diagnostic power of these indices. This review and meta-analysis aims to explore the diagnostic value of coagulation indices for DOACs. MATERIALS AND METHODS: PubMed, Web of Science, EMBASE, Clinical Trials.gov, and the Cochrane Library were searched from inception of each database to 15 February 2020. Studies reporting a relationship between coagulation indices and the gold standard (liquid chromatography/tandem mass spectrometry) were included in the analysis. RESULTS: Sixteen articles from 9169 citations evaluating the performance of coagulation indices were included in this review. A total of 236, 273, 273 rivaroxaban samples were included to assess the diagnostic power of anti-Xa activity (AXA), prothrombin time (PT), combined PT and activated partial thromboplastin time, respectively. A total of 268 dabigatran samples were included to assess the diagnostic performance of diluted thromboplastin time (dTT). AXA calibrated by rivaroxaban showed a sensitivity of 0.98 (95% confidence interval (CI): 0.91-0.99) and a specificity of 0.98 (95% CI: 0.94-0.99) at the threshold of 30 ng/mL. For dabigatran, the combined sensitivity of dTT was 0.76 (95% CI: 0.66-0.84) and combined specificity was 0.97 (95% CI: 0.92-0.99). CONCLUSIONS: DOAC-specific calibrated AXA was a good index to indicate concentration for rivaroxaban and apixaban. More studies on edoxaban and betrixaban are in need. Diluted TT, thrombin inhibitor assay, and ecarin-based assays were potential to measure dabigatran concentration. Due to the limited data, results should be validated in the future.
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Zhang et al. (2020) conducted a meta-analysis in Direct oral anticoagulant concentration. Coagulation indices (anti-Xa activity, diluted thromboplastin time) vs. Liquid chromatography/tandem mass spectrometry was evaluated on Diagnostic performance (sensitivity and specificity) (Sensitivity 0.98, 95% CI 0.91-0.99). Anti-Xa activity calibrated by rivaroxaban demonstrated a sensitivity of 0.98 (95% CI 0.91-0.99) and specificity of 0.98 for detecting direct oral anticoagulant concentration at a 30 ng/mL threshold.
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