Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography
Background Direct-acting oral anticoagulants (DOACs) do not require monitoring. Measurement of DOAC effect would be useful in the event of bleeding, trauma, and thromboembolism while on anticoagulation. We evaluated the effectiveness of the investigational DOAC assays on the TEG®6s Hemostasis Analyz...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Georg Thieme Verlag KG
2021-10-01
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| Series: | TH Open |
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| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/a-1692-1415 |
| _version_ | 1818484704628703232 |
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| author | Ramin Artang Joao D. Dias Mark Walsh Kevin Bliden Jorn D. Nielsen Maren Anderson Brian C. Thurston Udaya S. Tantry Jan Hartmann Paul A. Gurbel |
| author_facet | Ramin Artang Joao D. Dias Mark Walsh Kevin Bliden Jorn D. Nielsen Maren Anderson Brian C. Thurston Udaya S. Tantry Jan Hartmann Paul A. Gurbel |
| author_sort | Ramin Artang |
| collection | DOAJ |
| description | Background Direct-acting oral anticoagulants (DOACs) do not require monitoring. Measurement of DOAC effect would be useful in the event of bleeding, trauma, and thromboembolism while on anticoagulation. We evaluated the effectiveness of the investigational DOAC assays on the TEG®6s Hemostasis Analyzer to assess the anticoagulant effect of DOACs in patients treated for atrial fibrillation or deep vein thrombosis (DVT).
Methods Patients on treatment for a minimum of 7 days with standard doses of dabigatran, rivaroxaban, and apixaban were included. DOAC plasma concentrations and TEG®6s Reaction (R)-time were measured and correlated. The sensitivity, specificity, and negative predictive value (NPV) of R-time to detect DOAC concentrations of ≥30, ≥50, and ≥100 ng/mL were calculated.
Results A total of 189 patients were included, (n = 50) on apixaban, (n = 62) on rivaroxaban, (n = 53) on dabigatran, and (n = 24) on no DOAC were studied. Using the direct thrombin inhibitor (DTI) channel, R-time demonstrated strong linear correlation with dabigatran levels (r = 0.93, p < 0.0001). Using the antifactor Xa (AFXa) channel, R-time demonstrated strong nonlinear correlation with rivaroxaban and apixaban levels (r
s = 0.92 and 0.84, respectively, p < 0.0001 for both). R-time revealed strong sensitivity and NPV in detecting low DOAC levels for the predefined concentrations.
Conclusion R-time measured by TEG®6s DOAC-specific cartridge has a strong correlation with concentrations of the most commonly used DOACs with high sensitivity and NPV for detecting lower drug levels that are considered clinically relevant for patients in need of antidote, or prior to urgent surgery. Further studies to determine the relation of R-time to clinical outcomes are warranted. |
| first_indexed | 2024-12-10T15:58:24Z |
| format | Article |
| id | doaj.art-a579f2aee73f467a8bd1e62b2bbf4b46 |
| institution | Directory Open Access Journal |
| issn | 2512-9465 |
| language | English |
| last_indexed | 2024-12-10T15:58:24Z |
| publishDate | 2021-10-01 |
| publisher | Georg Thieme Verlag KG |
| record_format | Article |
| series | TH Open |
| spelling | doaj.art-a579f2aee73f467a8bd1e62b2bbf4b462022-12-22T01:42:34ZengGeorg Thieme Verlag KGTH Open2512-94652021-10-010504e570e57610.1055/a-1692-1415Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated ThrombelastographyRamin Artang0Joao D. Dias1Mark Walsh2Kevin Bliden3Jorn D. Nielsen4Maren Anderson5Brian C. Thurston6Udaya S. Tantry7Jan Hartmann8Paul A. Gurbel9Essentia Health St. Mary's Heart and Vascular Center, Duluth, Minnesota, United StatesHaemonetics Corp., Braintree, Massachusetts, United StatesMemorial Hospital of South Bend, Department of Energy Medicine, Sound Bend, Indiana, United StatesSinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United StatesBispebjerg University of Copenhagen Hospital, Department of Cardiology, Copenhagen, DenmarkUniversity of Minnesota School of Medicine, Duluth, Minnesota, United StatesSpartanburg Regional Medical Center, Division of Surgery, Spartanburg, South Carolina, United StatesSinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United StatesHaemonetics Corp., Braintree, Massachusetts, United StatesSinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, Maryland, United StatesBackground Direct-acting oral anticoagulants (DOACs) do not require monitoring. Measurement of DOAC effect would be useful in the event of bleeding, trauma, and thromboembolism while on anticoagulation. We evaluated the effectiveness of the investigational DOAC assays on the TEG®6s Hemostasis Analyzer to assess the anticoagulant effect of DOACs in patients treated for atrial fibrillation or deep vein thrombosis (DVT). Methods Patients on treatment for a minimum of 7 days with standard doses of dabigatran, rivaroxaban, and apixaban were included. DOAC plasma concentrations and TEG®6s Reaction (R)-time were measured and correlated. The sensitivity, specificity, and negative predictive value (NPV) of R-time to detect DOAC concentrations of ≥30, ≥50, and ≥100 ng/mL were calculated. Results A total of 189 patients were included, (n = 50) on apixaban, (n = 62) on rivaroxaban, (n = 53) on dabigatran, and (n = 24) on no DOAC were studied. Using the direct thrombin inhibitor (DTI) channel, R-time demonstrated strong linear correlation with dabigatran levels (r = 0.93, p < 0.0001). Using the antifactor Xa (AFXa) channel, R-time demonstrated strong nonlinear correlation with rivaroxaban and apixaban levels (r s = 0.92 and 0.84, respectively, p < 0.0001 for both). R-time revealed strong sensitivity and NPV in detecting low DOAC levels for the predefined concentrations. Conclusion R-time measured by TEG®6s DOAC-specific cartridge has a strong correlation with concentrations of the most commonly used DOACs with high sensitivity and NPV for detecting lower drug levels that are considered clinically relevant for patients in need of antidote, or prior to urgent surgery. Further studies to determine the relation of R-time to clinical outcomes are warranted.http://www.thieme-connect.de/DOI/DOI?10.1055/a-1692-1415clinical trials: oral anticoagulantscoagulation inhibitorsdiagnosis managementapixabanrivaroxabandabigatran |
| spellingShingle | Ramin Artang Joao D. Dias Mark Walsh Kevin Bliden Jorn D. Nielsen Maren Anderson Brian C. Thurston Udaya S. Tantry Jan Hartmann Paul A. Gurbel Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography TH Open clinical trials: oral anticoagulants coagulation inhibitors diagnosis management apixaban rivaroxaban dabigatran |
| title | Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography |
| title_full | Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography |
| title_fullStr | Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography |
| title_full_unstemmed | Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography |
| title_short | Measurement of Anticoagulation in Patients on Dabigatran, Rivaroxaban, and Apixaban Therapy by Novel Automated Thrombelastography |
| title_sort | measurement of anticoagulation in patients on dabigatran rivaroxaban and apixaban therapy by novel automated thrombelastography |
| topic | clinical trials: oral anticoagulants coagulation inhibitors diagnosis management apixaban rivaroxaban dabigatran |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/a-1692-1415 |
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