How to choose appropriate direct oral anticoagulant for patient with nonvalvular atrial fibrillation

Annals of Hematology

Volumn 95, Issue 3, 2016, Pages 437-449

  Schaefer, Jordan K ^a   McBane, Robert D ^a   Wysokinski, Waldemar E ^a  

^a MAYO CLINIC   (United States)

Author keywords

Apixaban; Dabigatran; Direct thrombin inhibitors; Factor Xa inhibitors; Nonvalvular atrial fibrillation; Rivaroxaban; Warfarin

Indexed keywords

AMIODARONE; APIXABAN; ATORVASTATIN; CARVEDILOL; DABIGATRAN; DIGOXIN; DILTIAZEM; DRONEDARONE; EDOXABAN; FELODIPINE; PRAZOSIN; QUINIDINE; RANOLAZINE; RIVAROXABAN; VERAPAMIL; WARFARIN; ANTICOAGULANT AGENT; BETA ALANINE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE; PYRIDONE DERIVATIVE; THIAZOLE DERIVATIVE;

ANTICOAGULANT THERAPY; ATRIAL FIBRILLATION; CEREBROVASCULAR ACCIDENT; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG STORAGE; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER METABOLISM; NONVALVULAR ATRIAL FIBRILLATION; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RENAL CLEARANCE; REVIEW; CLINICAL DECISION MAKING; ORAL DRUG ADMINISTRATION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STROKE;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; BETA-ALANINE; CLINICAL DECISION-MAKING; DABIGATRAN; HUMANS; PYRAZOLES; PYRIDINES; PYRIDONES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STROKE; THIAZOLES; WARFARIN;

EID: 84957428412     PISSN: 09395555     EISSN: 14320584     Source Type: Journal    
DOI: 10.1007/s00277-015-2566-x     Document Type: Review

References (69)

1. Press Announcements > FDA approves Pradaxa to prevent stroke in people with atrial fibrillation. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm230241.htm. Accessed July 8, 2014.
2. Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361(12):1139–1151
3. Patel MR, Mahaffey KW, Garg J et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365(10):883–891
4. Granger CB, Alexander JH, McMurray JJV et al (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365(11):981–992
5. Giugliano RP, Ruff CT, Braunwald E et al (2013) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369(22):2093–2104
6. Connolly SJ, Eikelboom J, Joyner C et al (2011) Apixaban in patients with atrial fibrillation. N Engl J Med 364(9):806–817
7. Chan NC, Paikin JS, Hirsh J, Lauw MN, Eikelboom JW, Ginsberg JS (2014) 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 111(5):798–807
8. FDA approves Pradaxa to prevent stroke in people with atrial fibrillation [news release]. Silver Spring, MD: U.S. Food and Drug Administration; October 19, 2010. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm. Accessed October 12, 2013.
9. European Medicines Agency. Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000829/human_med_000981.jsp Accessed October 12, 2013.
10. FDA expands use of Xarelto to treat, reduce recurrence of blood clots [news release]. Silver Spring, MD: U.S. Food and Drug Administration; November 2, 2012.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm. Accessed October 12, 2013.
11. European Medicines Agency. Xarelto. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000944/human_med_001155.jsp. Accessed October 12, 2013.
12. FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation [news release]. Silver Spring, MD: U.S. Food and Drug Administration; December 28, 2012.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333634.htm. Accessed February 16, 2014.
13. U.S. FDA approves Daiichi Sankyo’s once-daily SAVAYSA™ (edoxaban) tablets for reduction of stroke risk in non-valvular atrial fibrillation and for the treatment of venous thromboembolism http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm. Accessed January 17, 2015.
14. Kernan WN, Ovbiagele B, Black HR et al (2014) Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 45(7):2160–2236
15. January CT, Wann LS, Alpert JS et al (2014) AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation 2014
16. Atrial fibrillation: the management of atrial fibrillation. National Institute for Health and Care Excellence. CG 180. http://www.nice.org.uk/guidance/CG180/ Published June 2014, Accessed August 2014.
17. Camm AJ, Lip GYH, De Caterina R et al (2012) 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 33(21):2719–2747
18. You JJ, Singer DE, Howard PA et al (2012) Antithrombotic therapy for atrial fibrillation: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141(2 Suppl):e531S–e575S. doi:10.1378/chest.11-2304
19. Skanes AC, Healey JS, Cairns JA et al (2012) Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can J Cardiol 28(2):125–136
20. Heidbuchel H, Verhamme P, Alings M et al (2015) Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 17:1467–1507
21. Mann KG, Brummel K, Butenas S (2003) What is all that thrombin for? J Thromb Haemost 1(7):1504–1514
22. Stangier J (2008) Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 47(5):285–295
23. Mueck W, Stampfuss J, Kubitza D, Becka M (2014) Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet 53(1):1–16
24. Mendell J, Tachibana M, Shi M, Kunitada S (2011) Effects of food on the pharmacokinetics of edoxaban, an oral direct factor Xa inhibitor, in healthy volunteers. J Clin Pharmacol 51(5):687–694
25. Song Y, Wang X, Perlstein I et al (2013) Bioavailability of apixaban solution formulation and crushed tablets via nasogastric tube. Clin Pharmacol Ther 93(supplement 1):S120–S121
26. Hellwig T, Gulseth M (2013) Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation? Ann Pharmacother 47(11):1478–1487
27. Wang L, Zhang D, Raghavan N et al (2010) In vitro assessment of metabolic drug-drug interaction potential of apixaban through cytochrome P450 phenotyping, inhibition, and induction studies. Drug Metab Dispos 38:448–458
28. Chung N, Jeon H-K, Lien L-M et al (2011) Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thromb Haemost 105:535–544
29. Lega J-C, Bertoletti L, Gremillet C et al (2014) Consistency of safety and efficacy of new oral anticoagulants across subgroups of patients with atrial fibrillation. PLoS One 9(3):e91398
30. Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J (2012) Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 5(4):480–486
31. Skjøth F, Larsen TB, Rasmussen LH, Lip GYH (2014) Efficacy and safety of edoxaban in comparison with dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation. An indirect comparison analysis. Thromb Haemost 111(5):981–988
32. Dans AL, Connolly SJ, Wallentin L et al (2013) Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation 127(5):634–640
33. Eikelboom JW, Wallentin L, Connolly SJ et al (2011) 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 123(21):2363–2372
34. Majeed A, Hwang HG, Connolly SJ (2013) Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation 128:2325–2332
35. Lip GY, Clemens A, Noack H, Ferreira J, Connolly SJ, Yusuf S (2014) Patient outcomes using the European label for dabigatran. A post-hoc analysis from the RE-LY database. Thromb Haemost 111:933–942
36. Dogliotti A, Paolasso E, Giugliano RP (2013) Novel oral anticoagulants in atrial fibrillation: a meta-analysis of large, randomized, controlled trials vs warfarin. Clin Cardiol 36(2):61–67
37. Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ (2012) Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol 110(3):453–460
38. Baker WL, Phung OJ (2012) Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes 5(5):711–719
39. Rasmussen LH, Larsen TB, Graungaard T, Skjøth F, Lip GYH (2012) Primary and secondary prevention with new oral anticoagulant drugs for stroke prevention in atrial fibrillation: indirect comparison analysis. BMJ 345:e7097
40. Lip GYH, Larsen TB, Skjøth F, Rasmussen LH (2012) Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol 60(8):738–746. doi:10.1016/j.jacc.2012.03.019
41. Li H-F, Zhao R-L (2013) Lack of stroke subtype information may hinder indirect comparison between the ROCKET-AF and other trials of new oral anticoagulants. J Am Coll Cardiol 61(5):595–596
42. Chatterjee S, Sardar P, Biondi-Zoccai G, Kumbhani DJ (2013) New oral anticoagulants and the risk of intracranial hemorrhage: traditional and Bayesian meta-analysis and mixed treatment comparison of randomized trials of new oral anticoagulants in atrial fibrillation. JAMA Neurol 70(12):1486–1490
43. FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin. Food and Drug Administration. http://www.fda.gov/drugs/drugsafety/ucm396470.htm. Accessed August 2, 2014.
44. Larsen TB, Rasmussen LH, Skjøth F et al (2013) Efficacy and safety of dabigatran etexilate and warfarin in “real-world” patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol 61(22):2264–2273
45. Gomes T, Mamdani MM, Holbrook AM, Paterson JM, Hellings C, Juurlink DN (2013) Rates of hemorrhage during warfarin therapy for atrial fibrillation. CMAJ 185(2):E121–E127
46. Uchino K, Hernandez AV (2012) Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med 172:397–402
47. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L (2010) Randomized evaluation of long-term anticoagulation therapy investigators newly identified events in the RE-LY trial. N Engl J Med 363:1875–1876
48. Dowlatshahi D, Butcher KS, Asdaghi N et al (2012) Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal. Stroke 43(7):1812–1817
49. Hart RG, Diener H-C, Yang S et al (2012) Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke 43(6):1511–1517
50. Hylek EM, Held C, Alexander JH et al (2014) Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin: the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): predictors, characteristics, and clinical outcomes. J Am Coll Cardiol 63(20):2141–2147
51. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M (2011) Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 124(14):1573–1579
52. Zahir H, Brown KS, Vandell AG et al (2015) Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate. Circulation 131(1):82–90
53. Levi M, Moore KT, Castillejos CF et al (2014) Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers. J Thromb Haemost 12(9):1428–1436
54. Brown KS, Wickremasingha P, Parasrampuria DA et al (2015) The impact of a three-factor prothrombin complex concentrate on the anticoagulatory effects of the factor Xa inhibitor edoxaban. Thromb Res 136(4):825–831
55. Mo Y, Yam FK (2015) Recent advances in the development of specific antidotes for target-specific oral anticoagulants. Pharmacotherapy 35(2):198–207
56. Pollack CV Jr, Reilly PA, Eikelboom J, et al (2015) Idarucizumab for dabigatran reversal. N Engl J Med. Jun 22. [Epub ahead of print]
57. van Ryn J, Stangier J, Haertter S et al (2010) Dabigatran etexilate—a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 103:1116–1127
58. Huisman MV, Lip GY, Diener HC, Brueckmann M, van Ryn J, Clemens A (2012) Dabigatran etexilate for stroke prevention in patients with atrial fibrillation: resolving uncertainties in routine practice. Thromb Haemost 107:838–847
59. Hylek EM, Go AS, Chang Y et al (2003) Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 349(11):1019–1026
60. Wallentin L, Yusuf S, Ezekowitz MD et al (2010) 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 376(9745):975–983
61. Piccini JP, Hellkamp AS, Lokhnygina Y et al (2014) Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc 3(2):e000521
62. Wallentin L, Lopes RD, Hanna M et al (2013) Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation. Circulation 127(22):2166–2176
63. Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM (2010) Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro heart survey on atrial fibrillation. Chest 137(2):263–272
64. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ (2001) Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 285(22):2864–2870
65. Puurunen MK, Kiviniemi T, Schlitt A et al (2014) CHADS2, CHA2DS2-VASc and HAS-BLED as predictors of outcome in patients with atrial fibrillation undergoing percutaneous coronary intervention. Thromb Res 133(4):560–566
66. Friberg L, Rosenqvist M, Lip GYH (2012) Net clinical benefit of warfarin in patients with atrial fibrillation: a report from the Swedish atrial fibrillation cohort study. Circulation 125(19):2298–2307
67. Granger CB, Alexander JH, McMurray JJ et al (2011) ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365(11):981–992
68. Kocurek B (2009) Promoting medication adherence in older adults … the rest of us. Diabetes Spectr 22:80–84
69. Bloomfield HE, Krause A, Greer N et al (2011) Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Ann Intern Med 154(7):472–482