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Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review.
Chest. 2017 Jan; 151(1):127-138.Chest

Abstract

BACKGROUND

Direct oral anticoagulants (DOACs) are the treatment of choice for most patients with atrial fibrillation and/or noncancer-associated venous thromboembolic disease. Although routine monitoring of these agents is not required, assessment of anticoagulant effect may be desirable in special situations. The objective of this review was to summarize systematically evidence regarding laboratory assessment of the anticoagulant effects of dabigatran, rivaroxaban, apixaban, and edoxaban.

METHODS

PubMed, Embase, and Web of Science were searched for studies reporting relationships between drug levels and coagulation assay results.

RESULTS

We identified 109 eligible studies: 35 for dabigatran, 50 for rivaroxaban, 11 for apixaban, and 13 for edoxaban. The performance of standard anticoagulation tests varied across DOACs and reagents; most assays, showed insufficient correlation to provide a reliable assessment of DOAC effects. Dilute thrombin time (TT) assays demonstrated linear correlation (r2 = 0.67-0.99) across a range of expected concentrations of dabigatran, as did ecarin-based assays. Calibrated anti-Xa assays demonstrated linear correlation (r2 = 0.78-1.00) across a wide range of concentrations for rivaroxaban, apixaban, and edoxaban.

CONCLUSIONS

An ideal test, offering both accuracy and precision for measurement of any DOAC is not widely available. We recommend a dilute TT or ecarin-based assay for assessment of the anticoagulant effect of dabigatran and anti-Xa assays with drug-specific calibrators for direct Xa inhibitors. In the absence of these tests, TT or APTT is recommended over PT/INR for assessment of dabigatran, and PT/INR is recommended over APTT for detection of factor Xa inhibitors. Time since last dose, the presence or absence of drug interactions, and renal and hepatic function should impact clinical estimates of anticoagulant effect in a patient for whom laboratory test results are not available.

Authors+Show Affiliations

Department of Medicine, Division of Hematology, University of Washington, Seattle, WA. Electronic address: bts99@uw.edu.Department of Medicine and Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.Department of Medicine, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada.Department of Medicine, Division of Hematology, University of Washington, Seattle, WA.

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

27637548

Citation

Samuelson, Bethany T., et al. "Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: a Systematic Review." Chest, vol. 151, no. 1, 2017, pp. 127-138.
Samuelson BT, Cuker A, Siegal DM, et al. Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review. Chest. 2017;151(1):127-138.
Samuelson, B. T., Cuker, A., Siegal, D. M., Crowther, M., & Garcia, D. A. (2017). Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review. Chest, 151(1), 127-138. https://doi.org/10.1016/j.chest.2016.08.1462
Samuelson BT, et al. Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: a Systematic Review. Chest. 2017;151(1):127-138. PubMed PMID: 27637548.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review. AU - Samuelson,Bethany T, AU - Cuker,Adam, AU - Siegal,Deborah M, AU - Crowther,Mark, AU - Garcia,David A, Y1 - 2016/09/13/ PY - 2016/04/18/received PY - 2016/07/26/revised PY - 2016/08/24/accepted PY - 2016/9/18/pubmed PY - 2017/5/13/medline PY - 2016/9/18/entrez KW - antithrombotic therapy KW - deep venous thrombosis KW - direct oral anticoagulants KW - laboratory KW - pulmonary embolism SP - 127 EP - 138 JF - Chest JO - Chest VL - 151 IS - 1 N2 - BACKGROUND: Direct oral anticoagulants (DOACs) are the treatment of choice for most patients with atrial fibrillation and/or noncancer-associated venous thromboembolic disease. Although routine monitoring of these agents is not required, assessment of anticoagulant effect may be desirable in special situations. The objective of this review was to summarize systematically evidence regarding laboratory assessment of the anticoagulant effects of dabigatran, rivaroxaban, apixaban, and edoxaban. METHODS: PubMed, Embase, and Web of Science were searched for studies reporting relationships between drug levels and coagulation assay results. RESULTS: We identified 109 eligible studies: 35 for dabigatran, 50 for rivaroxaban, 11 for apixaban, and 13 for edoxaban. The performance of standard anticoagulation tests varied across DOACs and reagents; most assays, showed insufficient correlation to provide a reliable assessment of DOAC effects. Dilute thrombin time (TT) assays demonstrated linear correlation (r2 = 0.67-0.99) across a range of expected concentrations of dabigatran, as did ecarin-based assays. Calibrated anti-Xa assays demonstrated linear correlation (r2 = 0.78-1.00) across a wide range of concentrations for rivaroxaban, apixaban, and edoxaban. CONCLUSIONS: An ideal test, offering both accuracy and precision for measurement of any DOAC is not widely available. We recommend a dilute TT or ecarin-based assay for assessment of the anticoagulant effect of dabigatran and anti-Xa assays with drug-specific calibrators for direct Xa inhibitors. In the absence of these tests, TT or APTT is recommended over PT/INR for assessment of dabigatran, and PT/INR is recommended over APTT for detection of factor Xa inhibitors. Time since last dose, the presence or absence of drug interactions, and renal and hepatic function should impact clinical estimates of anticoagulant effect in a patient for whom laboratory test results are not available. SN - 1931-3543 UR - https://www.unboundmedicine.com/medline/citation/27637548/Laboratory_Assessment_of_the_Anticoagulant_Activity_of_Direct_Oral_Anticoagulants:_A_Systematic_Review_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(16)59148-X DB - PRIME DP - Unbound Medicine ER -