Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants

Journal of the American College of Cardiology

Volumn 64, Issue 11, 2014, Pages 1128-1139

  Cuker, Adam ^a   Siegal, Deborah M ^b   Crowther, Mark A ^b   Garcia, David A ^c  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b MCMASTER UNIVERSITY   (Canada)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Apixaban; Dabigatran; Laboratory; Monitoring; Rivaroxaban

Indexed keywords

ANTICOAGULANT AGENT; APIXABAN; DABIGATRAN; RIVAROXABAN; ANTITHROMBIN; BENZIMIDAZOLE DERIVATIVE; BETA ALANINE; BLOOD CLOTTING FACTOR 10A INHIBITOR; MORPHOLINE DERIVATIVE; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE; THIOPHENE DERIVATIVE;

ANTICOAGULATION; BLOOD CLOTTING TEST; DRUG ACCUMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SCREENING; EVIDENCE BASED MEDICINE; HUMAN; LABORATORY TEST; LIMIT OF QUANTITATION; OUTCOME ASSESSMENT; PARTIAL THROMBOPLASTIN TIME; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTHROMBIN TIME; QUALITY CONTROL; REVIEW; SYSTEMATIC REVIEW; THROMBIN TIME; ANALOGS AND DERIVATIVES; DRUG MONITORING; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ANTITHROMBINS; BENZIMIDAZOLES; BETA-ALANINE; DRUG MONITORING; FACTOR XA INHIBITORS; HUMANS; MORPHOLINES; PARTIAL THROMBOPLASTIN TIME; PYRAZOLES; PYRIDONES; THIOPHENES;

EID: 84922394366     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.05.065     Document Type: Article

References (59)

1. Husted S, De Caterina R, Andreotti F, et al. Nonvitamin K antagonist oral anticoagulants (NOACs): no longer new or novel. Thromb Haemost 2014; 111:781-2.
2. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
3. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91.
4. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-92.
5. Tripodi A. The laboratory and the direct oral anticoagulants. Blood 2013;121:4032-5.
6. Eby C. Novel anticoagulants and laboratory testing. Int J Lab Med 2013;35:262-8.
7. Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med 2011;155:529-36.
8. Gross PL, Weitz JI. New antithrombotic drugs. Clin Pharmacol Ther 2009;86:139-46.
9. Ezekowitz MD, Reilly PA, Nehmiz G, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol 2007;100:1419-26.
10. van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103:1116-27.
11. Liesenfeld KH, Schäfer HG, Trocóniz IF, et al. Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis. Br J Clin Pharmacol 2006;62:527-37.
12. Stangier J, Rathgen K, Stähle H, et al. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007;64:292-303.
13. Stangier J, Stähle H, Rathgen K, et al. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet 2008;47: 47-59.
14. Lindahl TL, Baghaei F, Blixter IF, et al. Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays. Thromb Haemost 2011;105:371-8.
15. Avecilla ST, Ferrell C, Chandler WL, et al. Plasma-diluted thrombin time to measure dabigatran concentrations during dabigatran etexilate therapy. Am J Clin Pathol 2012;137:572-4.
16. Dager WE, Gosselin RC, Kitchen S, et al. Dabigatran effects on the international normalized ratio, activated partial thromboplastin time, thrombin time, and fibrinogen: a multicenter, in vitro study. Ann Pharmacother 2012;46: 1627-36.
17. Douxfils J, Mullier F, Robert S, et al. Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate. Thromb Haemost 2012;107:985-97.
18. Halbmayer WM, Weigel G, Quehenberger P, et al. Interference of the new oral anticoagulant dabigatran with frequently used coagulation tests. Clin Chem Lab Med 2012;50:1601-5.
19. Harenberg J, Giese C, Marx S, et al. Determination of dabigatran in human plasma samples. Semin Thromb Hemost 2012;38:16-22.
20. Jones SD, Eaddy NS, Chan GT. Dabigatran: laboratory monitoring. Pathology 2012;44: 578-80.
21. Stangier J, Feuring M. Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis 2012;23:138-43.
22. van Ryn J, Baruch L, Clemens A. Interpretation of point-of-care INR results in patients treated with dabigatran. Am J Med 2012;125:417-20.
23. Antovic JP, Skeppholm M, Eintrei J, et al. Evaluation of coagulation assays versus LC-MS/MS for determinations of dabigatran concentrations in plasma. Eur J Clin Pharmacol 2013;69:1875-81.
24. Gosselin RC, Dwyre DM, Dager WE. Measuring dabigatran concentrations using a chromogenic ecarin clotting time assay. Ann Pharmacother 2013;47:1635-40.
25. Hawes EM, Deal AM, Funk-Adcock D, et al. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost 2013;11: 1493-502.
26. He S, Wallèn H, Bark N, et al. In vitro studies using a global hemostasis assay to examine the anticoagulant effects in plasma by the direct thrombin inhibitors: dabigatran and argatroban. J Thromb Thrombolysis 2013;35:131-9.
27. Helin TA, Pakkanen A, Lassila R, et al. Laboratory assessment of novel oral anticoagulants: method suitability and variability between coagulation laboratories. Clin Chem 2013;59:807-14.
28. Hapgood G, Butler J, Malan E, et al. The effect of dabigatran on the activated partial thromboplastin time and thrombin time as determined by the Hemoclot thrombin inhibitor assay in patient plasma samples. Thromb Haemost 2013;110: 308-15.
29. Favaloro EJ, Bonar R, Butler J, et al. Laboratory testing for the new oral anticoagulants: a review of current practice. Pathology 2013;45: 435-7.
30. Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939-an oral, direct factor Xa inhibitor. J Thromb Haemost 2005;3:514-21.
31. Xarelto Summary of Product Characteristics-EU. Available at: http://www.xarelto.com/html/downloads/2013-07-SPC-June2013-F2-low.pdf. Accessed August 17, 2013.
32. Kubitza D, Becka M, Voith B, et al. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther 2005;78:412-21.
33. Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939-an oral, direct factor Xa inhibitor-after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005;61:873-80.
34. Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141:e44S-88S.
35. Weinz C, Schwarz T, Kubitza D, et al. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2009;37:1056-64.
36. Mueck W, Lensing AW, Agnelli G, et al. Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet 2011;50:675-86.
37. Barrett YC, Wang Z, Frost C, et al. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010;104:1263-71.
38. Samama MM, Martinoli JL, LeFlem L, et al. Assessment of laboratory assays to measure rivaroxaban-an oral, direct factor Xa inhibitor. Thromb Haemost 2010;103:815-25.
39. Freyburger G, Macouillard G, Labrouche S, et al. Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 2011; 127:457-65.
40. Harenberg J, Kramer R, Giese C, et al. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability. J Thromb Thrombolysis 2011;32:267-71.
41. Hillarp A, Baghaei F, Fagerberg Blixter I, et al. Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays. J Thromb Haemost 2011;9:133-9.
42. Tripodi A, Chantarangkul V, Guinet C, et al. The international normalized ratio calibrated for rivaroxaban has the potential to normalize prothrombin time results for rivaroxaban-treated patients: results of an in vitro study. J Thromb Haemost 2011;9:226-8.
43. Asmis LM, Alberio L, Angelillo-Scherrer A, et al. Rivaroxaban: quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories. Thromb Res 2012;129:492-8.
44. Mani H, Rohde G, Stratmann G, et al. Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin. Thromb Haemost 2012;108:191-8.
45. Molenaar PJ, Dinkelaar J, Leyte A. Measuring rivaroxaban in a clinical laboratory setting, using common coagulation assays, Xa inhibition and thrombin generation. Clin Chem Lab Med 2012;50: 1799-807.
46. Samama MM, Contant G, Spiro TE, et al. Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls. Thromb Haemost 2012;107:379-87.
47. Samama MM, Contant G, Spiro TE, et al. Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: results of a multicenter field trial. Clin Appl Thromb Hemost 2012;18:150-8.
48. Dinkelaar J, Molenaar PJ, Ninivaggi M, et al. In vitro assessment, using thrombin generation, of the applicability of prothrombin complex concentrate as an antidote for rivaroxaban. J Thromb Haemost 2013;11:1111-8.
49. Douxfils J, Tamigniau A, Chatelain B, et al. Comparison of calibrated chromogenic anti-Xa assay and PT tests with LC-MS/MS for the therapeutic monitoring of patients treated with rivaroxaban. Thromb Haemost 2013;110:723-31.
50. Samama MM, Guinet C, Le Flem L, et al. Measurement of dabigatran and rivaroxaban in primary prevention of venous thromboembolism in 106 patients, who have undergone major orthopedic surgery: an observational study. J Thromb Thrombolysis 2013;35:140-6.
51. Scaglione F. New oral anticoagulants: comparative pharmacology with vitamin K antagonists. Clin Pharmacokinet 2013;52:69-82.
52. Frost C, Nepal S, Wang J, et al. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmacol 2013;76: 776-86.
53. Eliquis (apixaban). Package Insert. Princeton, NJ: Bristol-Myers Squibb Co.
54. Becker RC, Yang H, Barrett Y, et al. Chromogenic laboratory assays to measure the factor Xainhibiting properties of apixaban-an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011;32:183-7.
55. Barrett YC, Wang Z, Knabb RM. A novel prothrombin time assay for assessing the anticoagulant activity of oral factor Xa inhibitors. Clin Appl Thromb Hemost 2013;19:522-8.
56. Gouin-Thibault I, Flaujac C, Delavenne X, et al. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study. Thromb Haemost 2014;111:240-8.
57. Reilly PA, Lehr T, Haertter S, et al. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients in the RE-LY trial. J Am Coll Cardiol 2014;63:321-8.
58. Baglin T, Keeling D, Kitchen S. Effects on routine coagulation screens and assessment of anticoagulant intensity in patients taking oral dabigatran or rivaroxaban: guidance from the British Committee for Standards in Haematology. Br J Haematol 2012;159:427-9.
59. Cushman M, Lim W, Zakai NA. American Society of Hematology 2011 Clinical Practice Guide on Anticoagulant Dosing and Management of Anticoagulant-Associated Bleeding Complications in Adults. Available at: http://www.hematology.org/Clinicians/Guidelines-Quality/Quick-Ref/525.aspx. Accessed January 9, 2014.