Novel oral anticoagulants for stroke prevention in atrial fibrillation: Focus on apixaban

Advances in Therapy

Volumn 29, Issue 6, 2012, Pages 491-507

  Potpara, Tatjana S ^a   Polovina, Marija M ^b   Licina, Marina M ^b   Stojanovic, Radan M ^a   Prostran, Milica S ^a   Lip, Gregory Y H ^c  

^a UNIVERSITY OF BELGRADE   (Serbia)

^b CLINICAL CENTER OF SERBIA   (Serbia)

^c UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

Apixaban; Atrial fibrillation; Clinical trials; Dabigatran; Novel oral anticoagulants; Rivaroxaban; Stroke; Warfarin

Indexed keywords

ACETYLSALICYLIC ACID; AMIODARONE; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; ANTIVITAMIN K; APIXABAN; BETRIXABAN; DABIGATRAN; DABIGATRAN ETEXILATE; DAREXABAN; DRONEDARONE; EDOXABAN; PLACEBO; RIVAROXABAN; TARTARIC ACID; VERAPAMIL; WARFARIN; XIMELAGATRAN;

BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CAUSE OF DEATH; CLINICAL PRACTICE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; EMBOLISM; HEART ATRIUM FIBRILLATION; HUMAN; MAXIMUM PLASMA CONCENTRATION; PARTIAL THROMBOPLASTIN TIME; RECOMMENDED DRUG DOSE; REVIEW; RISK BENEFIT ANALYSIS; STROKE; THROMBIN TIME; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; HUMANS; MORPHOLINES; PYRAZOLES; PYRIDONES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STROKE; THIOPHENES; WARFARIN;

EID: 84866524336     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-012-0026-8     Document Type: Review

References (60)

1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857-67. (Pubitemid 351650486)
2. 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;172:623-31.
3. Wan Y, Heneghan C, Perera R, et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: A systematic review. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
4. Nieuwlaat R, Capucci A, Lip GYH, et al.; on behalf the Euro Heart Survey Investigators. Antithrombotic treatment in real-life atrial fibrillation patients: A report from the Euro Heart Survey on Atrial Fibrillation. Eur Heart J. 2006;27:3018-26. (Pubitemid 44963431)
5. Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: A systematic review. Am J Med. 2010;123:638-45.
6. Gallagher AM, Setakis E, Plumb JM, Clemens A, van Staa TP. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost. 2011;106:968-77.
7. Wieloch M, Själander A, Frykman V, Rosenqvist M, Eriksson N, Svensson PJ. Anticoagulation control in Sweden: Reports of time in therapeutic range, major bleeding, and thrombo-embolic complications from the national quality registry AuriculA. Eur Heart J. 2011;32:2282-9.
8. Matchar DB, Jacobson A, Dolor R, et al THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010;363: 1608-20.
9. Anderson JL, Horne BD, Stevens SM, et al. Randomized and Clinical Effectiveness Trial Comparing Two Pharmacogenetic Algorithms and Standard Care for Individualizing Warfarin Dosing: CoumaGen-II. Circulation. 2012; [Epub ahead of print].
10. Bussey HI. Transforming oral anticoagulation by combining international normalized ratio (INR) self testing and online automated management. J Thromb Thrombolysis. 2011;31:265-74.
11. Connolly SJ, Ezekowitz MD, Yusuf S, et al.; the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:1139-51.
12. Connolly SJ, Eikelboom J, Joyner C, et al.; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364:806-17.
13. Granger CB, Alexander JH, McMurray JJ, et al.; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-92.
14. Patel MR, Mahaffey KW, Garg J, et al.; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-91.
15. Sorbera LA, Bozzo J, Castaner J. Dabigatran/dabigatran etexilate. Drugs Fut. 2005;30:877-85.
16. Coordinating Committee; De Caterina R, Husted S, Wallentin L, et al. New Oral Anticoagulants in Atrial Fibrillation and Acute Coronary Syndromes: ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease Position Paper. J Am Coll Cardiol. 2012;59:1413-25.
17. Huisman MV, Lip GYH, Diener H, Brueckmann M, van Ryn J, Clemens A. Dabigatran etexilate for stroke prevention in patients with atrial fibrillation: Resolving uncertainties in routine practice. Thromb Haemost 2012; [Epub ahead of print].
18. Van Ryn J, Stangier J, Haertter S, Liesenfeld K, Wienen W, Feuring M. Dabigatran etexilate - A novel, reversible, oral direct thrombin inhibitor: Interpretation of coagulation assays and reversal of anticoagulation activity. Thromb Haemost. 2010;103:1116-27.
19. Pengo V, Crippa L, Falanga A, et al.; Italian Federation of Thrombosis Centers. Questions and answers on the use of dabigatran and perspectives on the use of other new oral anticoagulants in patients with atrial fibrillation. A consensus document of the Italian Federation of Thrombosis Centers (FCSA). Thromb Haemost. 2011;106:868-76.
20. Errikson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet. 2009;48:1-22.
21. Kreutz R. Pharmacodynamic and pharmacokinetic basics of rivaroxaban. Fundam Clin Pharmacol. 2012;26:27-32.
22. Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol. 2012;87:S141-5.
23. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: A randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011;124:1573-9.
24. Fukuda T, Honda Y, Kamisato C, Morishima Y, Shibano T. Reversal of anticoagulant effects of edoxaban, an oral, direct factor Xa inhibitor, with haemostatic agents. Thromb Haemost. 2012;107:253-9.
25. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G; American College of Chest Physicians. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl.):44S-88S.
26. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
27. Hohnloser SH, Oldgren J, Yang S, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation. 2012;125:669-76.
28. Ezekowitz MD, Wallentin L, Connolly SJ, et al.; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010;122:2246-53.
29. Wallentin L, Yusuf S, Ezekowitz MD, et al.; RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: An analysis of the RE-LY trial. Lancet. 2010;376:975-83.
30. Nagarakanti R, Ezekowitz MD, Oldgren J, et al. Dabigatran versus warfarin in patients with atrial fibrillation: An analysis of patients undergoing cardioversion. Circulation 2011;123:131-6.
31. Diener HC, Connolly SJ, Ezekowitz MD, et al.; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: A subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9:1157-63.
32. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: An analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011;123:2363-72.
33. Fox KAA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32:2387-94.
34. Banerjee A, Lane DA, Torp-Pedersen C, Lip GYH. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a "real world" atrial fibrillation population: A modeling analysis based on a nationwide cohort study. Thromb Haemost. 2012; 107:584-9.
35. Lip GY, Larsen TB, Skjøth F, Rasmussen LH. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2012; [Epub ahead of print].
36. Artang R, Rome E, Vidaillet H. Dabigatran and myocardial infarction, drug or class effect. Meta-analysis of randomized trials with oral direct thrombin inhibitors. J Am Coll Cardiol. 2012;59; 571.
37. Lakshminarayan K, Solid CA, Collins AJ, Anderson DC, Herzog CA. Atrial fibrillation and stroke in the general Medicare population: A 10-year perspective (1992 to 2002). Stroke. 2006;37:1969-74. (Pubitemid 44309888)
38. Camm AJ, Kirchof P, Lip GYH, et al. Guidelines for the management of atrial fibrillation. The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369-429.
39. Wann LS, Curtis AB, Ellenbogen KA, et al.; American College of Cardiology Foundation/American Heart Association Task Force. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on Dabigatran): A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011;123:1144-50.
40. Skanes AC, Healey JS, Cairns JA, et al.; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. Focused 2012 update of the Canadian cardiovascular society atrial fibrillation guidelines: Recommendations for stroke prevention and rate/rhythm control. Can J Cardiol. 2012;28:125-36.
41. Lip GYH, Huber K, Andreotti F, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary intervention/stenting. A Consensus Document of the European Society of Cardiology Working Group on Thrombosis, endorsed by the European Heart Rhythm Association (EHRA) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Thromb Haemost. 2010;103:13-28.
42. Faxon DP, Eikelboom JW, Berger PB, et al. Consensus document: Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. A North-American perspective. Thromb Haemost. 2011;106:572-84.
43. Huber K, Airaksinen KJ, Cuisset T, Marín F, Rubboli A, Lip GY. Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting: Similarities and dissimilarities between North America and Europe. Thromb Haemost. 2011;106:569-71.
44. Mega JL, Braunwald E, Wiviott SD, et al.; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012;366:9-19.
45. Alexander JH, Lopes RD, James S, et al.; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011;365:699-708.
46. Lakkireddy D, Reddy YM, Di Biase L, et al. Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: Results from a multicenter prospective registry. J Am Coll Cardiol. 2012;59:1168-74.
47. Winkle RA, Mead RH, Engel G, Kong MH, Patrawala RA. The use of dabigatran immediately after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2012;23:264-8.
48. Freeman JV, Zhu RP, Owens DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011;154:1-11.
49. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011; [Epub ahead of print].
50. Sorensen SV, Kansal AR, Connolly S, et al. Cost- effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: A Canadian payer perspective. Thromb Haemost. 2011;105:908-19.
51. Ahrens I, Lip GYH, Peter K. New oral anticoagulant drugs in cardiovascular disease. Thromb Haemost. 2010;104:49-60.
52. Lip GY, Rasmussen LH, Olsson SB, et al.; Steering Committee. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: A randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists. Eur Heart J. 2009;30:2897-907.
53. Lip GY, Rasmussen LH, Olsson SB, et al.; Steering Committee. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: A Phase II study of AZD0837 in patients who are appropriate for but unable or unwilling to take vitamin K antagonist therapy. Thromb Res. 2011;127:91-9.
54. Camm AJ, Bounameaux H. Edoxaban: A new oral direct factor Xa inhibitor. Drugs. 2011;71:1503-26.
55. Partida RA, Giugliano RP. Edoxaban: Pharmacological principles, preclinical and early-phase clinical testing. Future Cardiol. 2011;7:459-70.
56. Salazar DE, Mendell J, Kastrissios H, et al. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012;107:925-34.
57. 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;104:633-41.
58. Ellis DJ, Usman HM, Milner PG, Canafax DM, Ezekowitz MD. The first evaluation of a novel vitamin K antagonist, tecarfarin (ATI-5923), in patients with atrial fibrillation. Circulation. 2009;120:1029-35.
59. Bavisotto LM, Ellis DJ, Milner PG, Combs DL, Irwin I, Canafax DM. Tecarfarin, a novel vitamin K reductase antagonist, is not affected by CYP2C9 and CYP3A4 inhibition following concomitant administration of fluconazole in healthy participants. J Clin Pharmacol. 2011;51:561-74.
60. Eriksson BI, Dahl OE, Lassen MR, et al.; Fixit Study Group. Partial factor IXa inhibition with TTP889 for prevention of venous thromboembolism: An exploratory study. J Thromb Haemost. 2008;6:457-63. (Pubitemid 351280113)