Evaluating coagulation tests in patients with atrial fibrillation using direct oral anticoagulants

References

• Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361(12):1139-51
   PubMed Web of Science ®Google Scholar
• Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365(10):883-91
   PubMed Web of Science ®Google Scholar
• Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365(11):981-92
   PubMed Web of Science ®Google Scholar
• Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369(22):2093-104
   PubMed Web of Science ®Google Scholar
• Yeh CH, Hogg K, Weitz JI. Overview of the new oral anticoagulants: opportunities and challenges. Arterioscler Thromb Vasc Biol 2015;35(5):1056-65
   PubMed Web of Science ®Google Scholar
• Baglin T, Hillarp A, Tripodi A, et al. Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: A recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2013. [Epub ahead of print]
   Google Scholar
• Garcia D, Barrett YC, Ramacciotti E, Weitz JI. Laboratory assessment of the anticoagulant effects of the next generation of oral anticoagulants. J Thromb Haemost 2013;11(2):245-52
   PubMed Web of Science ®Google Scholar
• Stangier J, Feuring M. Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis 2012;23(2):138-43
   PubMed Web of Science ®Google Scholar
• 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(2):379-87
   PubMed Web of Science ®Google Scholar
• Barrett YC, Wang Z, Frost C, Shenker A. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010;104(6):1263-71
   PubMed Web of Science ®Google Scholar
• 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(6):1116-27
   PubMed Web of Science ®Google Scholar
• Cuker A, Siegal DM, Crowther MA, Garcia DA. Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants. J Am Coll Cardiol 2014;64(11):1128-39
   PubMed Web of Science ®Google Scholar
• Chan NC, Paikin JS, Hirsh J, et al. New oral anticoagulants for stroke prevention in atrial fibrillation: impact of study design, double counting and unexpected findings on interpretation of study results and conclusions. Thromb Haemost 2014;111(5):798-807
   PubMed Web of Science ®Google Scholar
• Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ 2012 344:e3675-2012
   PubMed Web of Science ®Google Scholar
• Yeh CH, Gross PL, Weitz JI. Evolving use of new oral anticoagulants for treatment of venous thromboembolism. Blood 2014;124(7):1020-8
   PubMed Web of Science ®Google Scholar
• Harenberg J, Du S, Wehling M, et al. Measurement of dabigatran, rivaroxaban and apixaban in samples of plasma, serum and urine, under real life conditions. An international study. Clin Chem Lab Med 2015; Epub ahead of print
   Google Scholar
• Pernod G, Albaladejo P, Godier A, et al. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis 2013;106(6-7):382-93
   PubMed Web of Science ®Google Scholar
• Hankey GJ, Norrving B, Hacke W, Steiner T. Management of acute stroke in patients taking novel oral anticoagulants. Int J Stroke 2014;9(5):627-32
   PubMed Web of Science ®Google Scholar
• Heidbuchel H, Verhamme P, Alings M, et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013;34(27):2094-106
   PubMed Web of Science ®Google Scholar
• Chan NC, Coppens M, Hirsh J, et al. Real-world variability in dabigatran levels in patients with atrial fibrillation. J Thromb Haemost 2015;13(3):353-9
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Pradaxa: Highlights of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf [Last accessed 12 September 2015]
   Google Scholar
• US Food and Drug Administration. Xarelto: Highlights of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf [Last accessed 12 September 2015]
   Google Scholar
• US Food and Drug Administration. Eliquis: Highlights of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf [Last accessed 12 September 2015]
   Google Scholar
• US Food and Drug Administration. Savaysa: Highlights of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf [Last accessed 12 September 2015]
   Google Scholar
• Brinkman HJ. Global assays and the management of oral anticoagulation. Thromb J 2015;13:9
   PubMed Web of Science ®Google Scholar
• Bates SM, Weitz JI. Coagulation assays. Circulation 2005;112(4):e53-60
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stahle 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(3):292-303
   PubMed Web of Science ®Google Scholar
• 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(5):985-97
   PubMed Web of Science ®Google Scholar
• Gosselin RC, Dwyre DM, Dager WE. Measuring dabigatran concentrations using a chromogenic ecarin clotting time assay. Ann Pharmacother 2013;47(12):1635-40
   PubMed Web of Science ®Google Scholar
• Herve T, Beaufils S, Kochan J, et al. Development of a New Automated Assay for Measurement of the Oral Direct Factor Xa Inhibitor Edoxaban Plasma Concentration 2014
   Google Scholar
• Douxfils J, Dogne JM, Mullier F, et al. Comparison of calibrated dilute thrombin time and aPTT tests with LC-MS/MS for the therapeutic monitoring of patients treated with dabigatran etexilate. Thromb Haemost 2013;110(3):543-9
   PubMed Web of Science ®Google Scholar
• Douxfils J, Lessire S, Dincq AS, et al. Estimation of dabigatran plasma concentrations in the perioperative setting. An ex vivo study using dedicated coagulation assays. Thromb Haemost 2015;113(4):862-9
   PubMed Web of Science ®Google Scholar
• 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(8):1493-502
   PubMed Web of Science ®Google Scholar
• 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(4):723-31
   PubMed Web of Science ®Google Scholar
• 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(1):191-8
   PubMed Web of Science ®Google Scholar
• Becker RC, Yang H, Barrett Y, et al. Chromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban–an oral, direct and selective factor Xa inhibitor. J Thromb Thrombolysis 2011;32(2):183-7
   PubMed Web of Science ®Google Scholar
• Harenberg J, Du S, Weiss C, et al. Report of the Subcommittee on Control of Anticoagulation on the determination of the anticoagulant effects of apixaban: communication from the SSC of the ISTH. J Thromb Haemost 2014;12(5):801-4
   PubMed Web of Science ®Google Scholar
• Harenberg J, Marx S, Weiss C, et al. Report of the Subcommittee of Control of Anticoagulation on the determination of the anticoagulant effects of rivaroxaban. J Thromb Haemost 2012;10(7):1433-6
   PubMedGoogle Scholar
• Jennings I, Kitchen S, Kitchen DP, et al. OR 285: Assays to measure direct oral anticoagulants (DOAC) - data from UK Neqas multicentre studies. Abstracts of the XXV Congress of the International Society on Thrombosis and Haemostasis, June 20-25, 2015. J Thromb Haemost 2015;13(Suppl 2):1-997
   Google Scholar
• Adcock DM, Gosselin R. Direct Oral Anticoagulants (DOACs) in the Laboratory: 2015 Review. Thromb Res 2015;136(1):7-12
   PubMed Web of Science ®Google Scholar
• 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: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol 2014;63(4):321-8
   PubMed Web of Science ®Google Scholar
• 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(2):308-15
   PubMed Web of Science ®Google Scholar
• Lessire S, Douxfils J, Baudar J, et al. Is Thrombin time useful for the assessment of dabigatran concentrations? An in vitro and ex vivo study. Thromb Res 2015;136(3):693-6
   PubMed Web of Science ®Google Scholar
• 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(2):371-8
   PubMed Web of Science ®Google Scholar
• Eikelboom JW, Hirsh J. Monitoring unfractionated heparin with the aPTT: time for a fresh look. Thromb Haemost 2006;96(5):547-52
   PubMed Web of Science ®Google Scholar
• Nowak G. The ecarin clotting time, a universal method to quantify direct thrombin inhibitors. Pathophysiol Haemost Thromb 2003;33(4):173-83
   PubMed Web of Science ®Google Scholar
• Lange U, Nowak G, Bucha E. Ecarin chromogenic assay–a new method for quantitative determination of direct thrombin inhibitors like hirudin. Pathophysiol Haemost Thromb 2003;33(4):184-91
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Pradaxa, summary of product characteristics. 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf [Last accessed 3 August 2015]
   Google Scholar
• Harenberg J, Giese C, Marx S, Kramer R. Determination of dabigatran in human plasma samples. Semin Thromb Hemost 2012;38(1):16-22
   PubMed Web of Science ®Google Scholar
• Lind SE, Boyle ME, Fisher S, et al. Comparison of the aPTT with alternative tests for monitoring direct thrombin inhibitors in patient samples. Am J Clin Pathol 2014;141(5):665-74
   PubMed Web of Science ®Google Scholar
• Douxfils J, Chatelain B, Hjemdahl P, et al. Does the Russell Viper Venom time test provide a rapid estimation of the intensity of oral anticoagulation? A cohort study. Thromb Res 2015;135(5):852-60
   PubMed Web of Science ®Google Scholar
• 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(10):675-86
   PubMed Web of Science ®Google Scholar
• Douxfils J, Mullier F, Loosen C, et al. Assessment of the impact of rivaroxaban on coagulation assays: laboratory recommendations for the monitoring of rivaroxaban and review of the literature. Thromb Res 2012;130(6):956-66
   PubMed Web of Science ®Google Scholar
• 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(4):815-25
   PubMed Web of Science ®Google Scholar
• 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(1):133-9
   PubMed Web of Science ®Google Scholar
• Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time. Thromb Haemost 2011;106(1):156-64
   PubMed Web of Science ®Google Scholar
• Konigsbrugge O, Quehenberger P, Belik S, et al. Anti-coagulation assessment with prothrombin time and anti-Xa assays in real-world patients on treatment with rivaroxaban. Ann Hematol 2015;94(9):1463-71
   PubMed Web of Science ®Google Scholar
• Gosselin RC, Adcock Funk DM, Taylor JM, et al. Comparison of anti-Xa and dilute Russell viper venom time assays in quantifying drug levels in patients on therapeutic doses of rivaroxaban. Arch Pathol Lab Med 2014;138(12):1680-4
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Apixaban, Summary of Product Characteristics, 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf [Last accessed 3 August 2015]
   Google Scholar
• Jourdi G, Siguret V, Martin AC, et al. Association rate constants rationalise the pharmacodynamics of apixaban and rivaroxaban. Thromb Haemost 2015;114(1):78-86
   PubMed Web of Science ®Google Scholar
• Douxfils J, Chatelain C, Chatelain B, et al. Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide. Thromb Haemost 2013;110(2):283-94
   PubMed Web of Science ®Google Scholar
• Dale BJ, Ginsberg JS, Johnston M, et al. Comparison of the effects of apixaban and rivaroxaban on prothrombin and activated partial thromboplastin times using various reagents. J Thromb Haemost 2014;12(11):1810-15
   PubMed Web of Science ®Google Scholar
• 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(2):240-8
   PubMed Web of Science ®Google Scholar
• Exner T, Ellwood L, Rubie J, Barancewicz A. Testing for new oral anticoagulants with LA-resistant Russells viper venom reagents. An in vitro study. Thromb Haemost 2013;109(4):762-5
   PubMed Web of Science ®Google Scholar
• Ruff CT, Giugliano RP, Braunwald E, et al. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet 2015;385(9984):2288-95
   PubMed Web of Science ®Google Scholar
• Weitz JI, Connolly SJ, Patel I, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost 2010;104(3):633-41
   PubMed Web of Science ®Google Scholar
• Cuker A, Husseinzadeh H. Laboratory measurement of the anticoagulant activity of edoxaban: a systematic review. J Thromb Thrombolysis 2015;39(3):288-94
   PubMed Web of Science ®Google Scholar
• Samama MM, Mendell J, Guinet C, et al. In vitro study of the anticoagulant effects of edoxaban and its effect on thrombin generation in comparison to fondaparinux. Thromb Res 2012;129(4):e77-82
   PubMed Web of Science ®Google Scholar