title: Determination of non-Vitamin K oral anticoagulant (NOAC) effects using a new-generation thrombelastography TEG 6s system.
abstract: Non vitamin K oral anticoagulants (NOACs) do not require regular monitoring but information about their pharmacodynamic effect may be importantin situations like trauma, stroke oremergent surgery. Currently, no standardized point-of-care test is available to evaluate the anticoagulant effects of NOACs. We evaluated the anticoagulant effect of NOACs with the next generation point-of-care TEG assay (TEG® 6S) based on a fully-automated thrombelastography system. We used two TEG® 6S assays, the DTI assay and Anti-Factor Xa (AFXa) assay, to detect anticoagulant effects and classify NOACs. Blood from healthy volunteers (n = 26) was used to obtain a baseline reference range. Data derived from patients on factor Xa inhibitors (FXi) (rivaroxaban and apixaban) (n = 39), and direct thrombin inhibitors (DTIs) (dabigatran) (n = 25) were compared against the reference range for detection of drug effect and drug classification. TEG®6s R-time highly correlated to each NOAC. Presence of NOACs caused elongation of R-time on the AFXa assay compared to the reference range (4.3 ± 1.7 vs. 1.3 ± 0.3 min. for FXi, p < 0.001 and 3.5 ± 1.2 vs. 1.3 ± 0.3 min. for DTI, p < 0.001). R-time on the DTI assay was elongated only in presence of a DTI (3.4 ± 1.0 vs. 1.5 ± 0.2 min, p < 0.001). The cutoff for detection of a DTI effect was an R time of 1.9 min and for anti-Xa effect was 1.95 min. For detection of NOAC therapy, there was ≥92% sensitivity and ≥95% specificity. The automated TEG®6s NOAC assay may be an effective tool to identify an anticoagulant effect from NOAC therapy and facilitate care of patients with bleeding or at risk of bleeding in the event of needing emergency surgery.
authors.affiliation: Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA, USA.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Bliden
authors.affiliation: Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA, USA.
authors.forename: Rahul
authors.initials: R
authors.lastname: Chaudhary
authors.affiliation: Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA, USA.
authors.forename: Nafees
authors.initials: N
authors.lastname: Mohammed
authors.affiliation: Haemonetics Corporation, Braintree, MA, USA.
authors.forename: Adina A
authors.initials: AA
authors.lastname: Muresan
authors.affiliation: Haemonetics Corporation, Braintree, MA, USA.
authors.forename: Carlos G
authors.initials: CG
authors.lastname: Lopez-Espina
authors.affiliation: Coramed Technologies, Niles, IL, USA.
authors.forename: Eli
authors.initials: E
authors.lastname: Cohen
authors.affiliation: Coramed Technologies, Niles, IL, USA.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Raviv
authors.affiliation: Haemonetics Corporation, Braintree, MA, USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Doubleday
authors.affiliation: Haemonetics Corporation, Braintree, MA, USA.
authors.forename: Fowzia
authors.initials: F
authors.lastname: Zaman
authors.affiliation: Haemonetics Corporation, Braintree, MA, USA.
authors.forename: Blessy
authors.initials: B
authors.lastname: Mathew
authors.affiliation: Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA, USA.
authors.forename: Udaya S
authors.initials: US
authors.lastname: Tantry
authors.affiliation: Interventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA, USA. Paul.Gurbel@inova.org.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gurbel
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use; D001331:Automation; D000069604:Dabigatran / Q000627:therapeutic use; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods / Q000592:standards; D065427:Factor Xa Inhibitors / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000175:diagnosis; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D011720:Pyrazoles / Q000627:therapeutic use; D011728:Pyridones / Q000627:therapeutic use; D000069552:Rivaroxaban / Q000627:therapeutic use; D013916:Thrombelastography / Q000295:instrumentation / Q000379:methods* / Q000592:standards
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Novel oral anticoagulants (NOAC); Point-of-care; TEG-6s; Thrombelastography