Abstract 17582: Monitoring Novel Anticoagulants Dabigatron, Rivaroxaban and Apixaban Using Modified Thrombelastography
Background: Novel anticoagulants NOACS dabigatran DABI rivaroxaban RIVA and apixaban APIX do not require routine monitoring. There are situations where monitoring would be useful including bleedings, trauma, and thromboembolic events while on anticoagulation.
The aim of this in vivo study was to assess the anticoagulant effect of NOACS with novel modified TEG assay containing ecarin and factor Xa concentrate.
Methods: 9 healthy male volunteers were given single dose of oral DABI 150mg or RIVA 20mg or APIX 5mg and were phlebotomized at 0, 1 and 3 hours after intake of NOAC. Reaction time R was measured using TEG®5000. Concentrations (conc.) of DABI, RIVA and APIX were measured using chromogenic assay Biophen® DTI and DiXaI. Based on available literature on pharmacokinetics of NOACS, clinical range for each agent was estimated. The R values was correlated to the drug conc. and sensitivity SN, specificity SP, positive and negative predictive values (PPV&NPV) for the minimum therapeutic range of each agent was calculated.
Results: Using Ecarin assay, R was highly correlated with DABI conc. r = 0.96, p < 0.0001. R value of >5.7 had 88% SN 100% SP, 100% PPV and 95% NPV for DABI conc. of >50ng/ml.
Using Factor Xa assay, R was highly correlated with RIVA conc. r = 0.89, p < 0.0001. R value of >4.8 had 94% SN, 100% SP, 100% PPV, and 92% NPV for RIVA conc. of >100ng/ml.
Using Factor Xa assay R was highly correlated with APIX conc. r = 0.86, p < 0.0001. R value of >4.3 had 93% SN, 100% SP, 100 PPV and 93% NPV for APIX conc. of >50ng/ml.
Conclusion: We have for the first time demonstrated that TEG® point-of-care device can monitor the NOACS effect on the hemostasis with highly significant correlation with the drug levels of each agent. This novel technology is easy to use on whole blood without need for specialized expertise. Larger clinical studies are warranted for correlation of TEG findings and clinical outcome.
Author Disclosures: R. Artang: Speakers Bureau; Modest; Bristol Meyer-Squib. Honoraria; Modest; Haemoentics, Portolla. G. Galloway: None. J. Dalsgaard Nielsen: None.
- © 2015 by American Heart Association, Inc.