Key result
The modified low-tissue-factor thromboelastometric test (TFTEM) detected direct FXa inhibitors at concentrations >30 ng/mL with 96% sensitivity and 95% specificity, outperforming standard tests.
Why the study?
Data on the detection rates of apixaban and edoxaban using modified compared to standard thromboelastometric tests were missing.
Do modified thromboelastometric tests provide improved sensitivity and specificity for detecting DOACs compared to standard tests in-vitro?
Observational (n=30)
No
Do modified thromboelastometric tests provide improved sensitivity and specificity for detecting DOACs compared to standard tests in-vitro?
Effect estimate: AUC 0.9828
Absolute Event Rate: 96% vs 81%
p-value: p=<0.0001
Modified thromboelastometric tests (TFTEM and ECATEM) demonstrate high sensitivity and specificity for detecting clinically relevant concentrations of DOACs in-vitro, outperforming standard tests.
BACKGROUND: The detection of direct oral anticoagulants (DOACs) is still challenging but important in emergency patients. We recently demonstrated that modified thromboelastometry can detect rivaroxaban and dabigatran. Data on the detection rates of modified compared to standard thromboelastometric tests of apixaban and edoxaban, are missing. The aim of this in-vitro dose-effect-study was to add data on these DOACs and to evaluate thromboelastometric tests in-vitro using data of both studies. METHODS: The study was approved by the Ludwig-Maximilians-University ethics committee (No 17-525-2). Written informed consent was obtained from all individuals. Blood samples of healthy volunteers and samples of 10 volunteers for each DOAC were used. Blood samples were spiked with six different concentrations of edoxaban and apixaban (0ng/ml; 31.25ng/ml; 62.5ng/ml; 125ng/ml; 250 ng/ml; 500ng/ml). Modified tests (low-tissue-factor test TFTEM and ecarin-based test ECATEM) as well as standard tests (e.g. FIBTEM) analyzing extrinsic pathway of coagulation were used. Receiver operating characteristics analyzes were performed as well as regression analyzes. RESULTS: = 0.8603; p < 0.0001). The detection of direct FXa inhibitors (> 30 ng/mL) was successful with FIBTEM CT with a sensitivity and specificity of 81% and 90%, respectively. As expected, ECATEM CT was not prolonged by direct FXa-inhibitors due to its specificity for direct thrombin inhibitors. Again, TFTEM CT provided the highest sensitivity and specificity for the detection of direct FXa inhibitors with 96% and 95%, respectively. ECATEM test showed 100% sensitivity and 100% specificity for the detection of dabigatran. CONCLUSIONS: Our study presents modified thromboelastometric tests with improved detection of even low DOAC concentrations > 30 ng/mL, including apixaban in-vitro. The study thus complements the previously published data on dabigatran and rivaroxaban. Validation studies must confirm the results due to the explanatory design of this study.
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Groene et al. (2022) conducted an observational in Healthy volunteers (in-vitro DOAC detection) (n=30). Modified thromboelastometric tests (TFTEM and ECATEM) vs. Standard thromboelastometric tests (FIBTEM) was evaluated on Sensitivity for detection of direct FXa inhibitors (> 30 ng/mL) (AUC 0.9828, p=<0.0001). The modified low-tissue-factor thromboelastometric test (TFTEM) detected direct FXa inhibitors at concentrations >30 ng/mL with 96% sensitivity and 95% specificity, outperforming standard tests.
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