Key result
Heparin-calibrated anti-Xa assay excludes significant DOAC levels with ~94% negative predictive value.
Why the study?
DOACs require monitoring in critical clinical situations, but specific monitoring tests are not universally available in all laboratories.
Does a heparin-calibrated anti-Xa assay accurately estimate apixaban and rivaroxaban concentrations to guide therapeutic decisions in emergency patients scheduled for acute interventions?
Cohort (n=137)
Yes
Does a heparin-calibrated anti-Xa assay accurately estimate apixaban and rivaroxaban concentrations to guide therapeutic decisions in emergency patients scheduled for acute interventions?
Effect estimate: NPV 94%
A widespread heparin-calibrated anti-Xa assay can reliably estimate or exclude significant plasma concentrations of apixaban and rivaroxaban to safely guide urgent invasive procedures when specific DOAC assays are unavailable.
May support heparin-calibrated anti-Xa assay to exclude significant DOAC levels pre-procedure when specific assays unavailable; leaves open prospective validation before practice change.
(1) Background: Direct oral anticoagulants (DOACs) require monitoring in some critical clinical situations. The specific tests for DOAC monitoring are not yet available in all labs. The aim of this study was to evaluate if a unique, more widespread heparin-calibrated anti-Xa assay could be suitable to estimate the concentrations of apixaban and rivaroxaban in order to establish an algorithm helping our clinicians in their therapeutic decision for patients treated with DOACs in emergencies. (2) Methods: A first retrospective part allowed us to determine of a conversion factor between the measured DOAC concentration and the deducted anti-Xa heparin activity based on optic density. During the second prospective part, both DOAC concentration (ng/mL) and anti-Xa activity heparin (UI/mL) were measured on the same sample, and the previously determined conversion factor was applied to each UI/mL value. We then compared the calculated and measured DOAC concentration values. (3) Results: The analysis of the derivation cohort confirmed a good correlation, especially between the anti-Xa heparin activity and the apixaban concentrations (r = 0.97). Additionally, we determined heparin-calibrated anti-Xa assay cut-offs for invasive procedures at 0.3 UI/mL and for intravenous thrombolysis at 0.51 UI/mL using ROC curves with a sensitivity at 98% and specificity at 95% for 0.3 UI/mL and a sensitivity at 97.7% and specificity at 88.2% for the cut-off of 0.51 UI/mL. In the validation cohort, we confirmed the agreement between measured and calculated DOAC concentrations for the low values, especially around cut-offs with an excellent negative predictive value for 0.51 UI/mL (94% for apixaban and 100% for rivaroxaban) and a good negative predictive value for 0.3 UI/mL (83.3% for apixaban and 85.7% for rivaroxaban). (4) Conclusions: Our results confirm that it is possible to correctly predict or exclude the presence of apixaban/rivaroxaban in emergency situations when specific tests are not readily available.
No takes yet. Share an insight, caveat, or question.
Riahi et al. (2023) conducted a cohort in Patients treated with apixaban or rivaroxaban evaluated for urgent clinical procedures (n=137). Heparin-calibrated anti-Xa assay vs. Specific DOAC anti-Xa assay (reference standard) was evaluated on Negative predictive value of the heparin-calibrated anti-Xa assay at 0.51 UI/mL cut-off for apixaban (validation cohort) (NPV 94%). A heparin-calibrated anti-Xa assay cut-off of 0.51 UI/mL demonstrated an excellent negative predictive value (94% for apixaban, 100% for rivaroxaban) to exclude significant DOAC concentrations.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: