Monitoring and reversal strategies for new oral anticoagulants

Expert Review of Cardiovascular Therapy

Volumn 13, Issue 1, 2015, Pages 95-103

  Vanden Daelen, Sophie ^a   Peetermans, Marijke ^a   Vanassche, Thomas ^a   Verhamme, Peter ^a   Vandermeulen, Erik ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

andexanet; antidote; apixaban; bleeding; dabigatran; idarucizumab; monitoring; oral anticoagulants; reversal strategies; rivaroxaban

Indexed keywords

ACTIVATED CARBON; ACTIVATED PROTHROMBIN COMPLEX; ANDEXANET ALFA; ANTICOAGULANT AGENT; ANTIDOTE; APIXABAN; CIRAPARANTAG; DABIGATRAN; ECARIN; EDOXABAN; FRESH FROZEN PLASMA; HEMOSTATIC AGENT; IDARUCIZUMAB; LOW MOLECULAR WEIGHT HEPARIN; MELAGATRAN; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RIVAROXABAN;

ANTICOAGULANT THERAPY; ANTICOAGULATION; BLEEDING; BLOOD CLOTTING TEST; BLOOD CLOTTING TIME; BRAIN HEMORRHAGE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG MONITORING; EMERGENCY SURGERY; HEMODIALYSIS; HEMOSTASIS; HUMAN; LABORATORY TEST; LIQUID CHROMATOGRAPHY; NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROTHROMBIN TIME; REVIEW; THROMBIN TIME; THROMBOCYTE AGGREGATION; THROMBOELASTOGRAPHY; TURNAROUND TIME; ANIMAL; ATRIAL FIBRILLATION; BLOOD CLOTTING; CHEMICALLY INDUCED; DRUG EFFECTS; HEMORRHAGE; ORAL DRUG ADMINISTRATION; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ANIMALS; ANTICOAGULANTS; ATRIAL FIBRILLATION; BLOOD COAGULATION; HEMORRHAGE; HUMANS; VENOUS THROMBOEMBOLISM;

EID: 84919460713     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/14779072.2015.987126     Document Type: Review

References (43)

1. Agarwal S, Hachamovitch R, Menon V. Current trial-associated outcomes with warfarin in prevention of stroke in patients with nonvalvular atrial fibrillation: a meta-analysis. Arch Intern Med 2012; 172(8):623-31.discussion 631-3
2. Ma Q. Development of oral anticoagulants. Br J Clin Pharmacol 2007;64(3):263-5
3. 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
4. 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
5. 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
6. 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
7. 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
8. Moore TJ, Cohen MR, Mattison DR. Dabigatran, bleeding, and the regulators. BMJ 2014;349:g4517
9. Moore CL, Bomann S, Daniels B, et al. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone-the STONE score: retrospective and prospective observational cohort studies. BMJ 2014;348:g2191
10. Heidbuchel H, Verhamme P, Alings M, et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15(5): 625-51
11. Siegal DM, Crowther MA. Acute management of bleeding in patients on novel oral anticoagulants. Eur Heart J 2013; 34(7):489-498
12. Jackson LR 2nd, Becker RC. Novel oral anticoagulants: pharmacology, coagulation measures, and considerations for reversal. J Thromb Thrombolysis 2014;37(3):380-91
13. 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
14. Lippi G, Ardissino D, Quintavalla R, Cervellin G. Urgent monitoring of direct oral anticoagulants in patients with atrial fibrillation: a tentative approach based on routine laboratory tests. J Thromb Thrombolysis 2014;38(2):269-74
15. van Ryn J, Grottke O, Spronk H. Measurement of dabigatran in standardly used clinical assays, whole blood viscoelastic coagulation, and thrombin generation assays. Clin Lab Med 2014;34(3):479-501
16. Gous T, Couchman L, Patel JP, et al. Measurement of the direct oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in human plasma using turbulent flow liquid chromatography with high-resolution mass spectrometry. Ther Drug Monit 2014;36(5): 597-605
17. Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs 2011;71(12):1503-26
18. Freyburger G, Macouillard G, Labrouche S, Sztark F. 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(5): 457-65
19. Adelmann D, Wiegele M, Wohlgemuth RK, et al. Measuring the activity of apixaban and rivaroxaban with rotational thrombelastometry. Thromb Res 2014; 134(4):918-23
20. Majeed A, Schulman S. Bleeding and antidotes in new oral anticoagulants. Best Pract Res Clin Haematol 2013;26(2): 191-202
21. 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 20.Arch Cardiovasc Dis 2013; 106(6-7):382-93
22. Levi M, Eerenberg E, Kamphuisen PW. Bleeding risk and reversal strategies for old and new anticoagulants and antiplatelet agents. J Thromb Haemost 2011;9(9): 1705-12
23. Pragst I, Zeitler SH, Doerr B, et al. Reversal of dabigatran anticoagulation by prothrombin complex concentrate (Beriplex P/N) in a rabbit model. J Thromb Haemost 2012;10(9):1841-8
24. Grottke O, van Ryn J, Spronk HM, Rossaint R. Prothrombin complex concentrates and a specific antidote to dabigatran are effective ex-vivo in reversing the effects of dabigatran in an anticoagulation/liver trauma experimental model. Crit Care 2014;18(1):R27
25. Zhou W, Schwarting S, Illanes S, et al. Hemostatic therapy in experimental intracerebral hemorrhage associated with the direct thrombin inhibitor dabigatran. Stroke 2011;42(12):3594-9
26. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011;124(14): 1573-9
27. Marlu R, Hodaj E, Paris A, et al. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost 2012; 108(2):217-24
28. Gonsalves WI GV, Patnaik MM. Management of bleeding complications in patients on new oral anticoagulants. J Hematol Transfus 2014;2(1):1015
29. Steiner T, Bohm M, Dichgans M, et al. Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban. Clin Res Cardiol 2013;102(6): 399-412
30. Stangier J, Rathgen K, Stahle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 2010;49(4):259-68
31. Schiele F, van Ryn J, Canada K, et al. A specific antidote for dabigatran: functional and structural characterization. Blood 2013; 121(18):3554-62
32. Millar CM and Lane DA. Blocking direct inhibitor bleeding. Blood 2013;121(18): 3543-4
33. Reversal of Dabigatran Anticoagulant Effect With Idarucizumab. Available from: http://clinicaltrials.gov/show/NCT02104947 [Accessed on 16 Sept 2014]
34. Kalus JS. Pharmacologic interventions for reversing the effects of oral anticoagulants. Am J Health Syst Pharm 2013; 70(10 Suppl 1):S12-21
35. Fukuda T, Honda Y, Kamisato C, et al. Reversal of anticoagulant effects of edoxaban, an oral, direct factor Xa inhibitor, with haemostatic agents. Thromb Haemost 2012;107(2):253-9
36. Martin AC, Le Bonniec B, Fischer AM, et al. Evaluation of recombinant activated factor VII, prothrombin complex concentrate, and fibrinogen concentrate to reverse apixaban in a rabbit model of bleeding and thrombosis. Int J Cardiol 2013;168(4):4228-33
37. Perzborn E, Gruber A, Tinel H, et al. Reversal of rivaroxaban anticoagulation by haemostatic agents in rats and primates. Thromb Haemost 2013;110(1):162-72
38. Halim AB, Samama MM, Mendell J. Ex vivo reversal of the anticoagulant effects of edoxaban. Thromb Res 2014;134(4):909-13
39. Godier A, Miclot A, Le Bonniec B, et al. Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model. Anesthesiology 2012;116(1):94-102
40. Dentali F, Marchesi C, Pierfranceschi MG, et al. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. A metaanalysis. Thromb Haemost 2011;106(3): 429-38
41. Escolar G, Fernandez-Gallego V, Arellano-Rodrigo E, et al. Reversal of apixaban induced alterations in hemostasis by different coagulation factor concentrates: significance of studies in vitro with circulating human blood. PLoS One 2013; 8(11):e78696
42. Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013;19(4):446-51
43. Ansell J, Bakhru S, Laulicht B, et al. Use of PER977 to reverse the anticoagulant effect of edoxaban. N Engl J Med 2014. [Epub ahead of print]