Primary prevention of ischaemic stroke in atrial fibrillation: New oral anticoagulant drugs for all?

Current Vascular Pharmacology

Volumn 12, Issue 3, 2014, Pages 373-383

  Foley, James ^a   Kirchhof, Paulus ^a   Lip, Gregory Y H ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

Apixaban; Atrial fibrillation; Dabigatran; Rivaroxaban; Stroke prevention; Warfarin

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; APIXABAN; BLOOD CLOTTING FACTOR 10A; DABIGATRAN ETEXILATE; IDRAPARINUX; RIVAROXABAN; THROMBIN; VITAMIN K EPOXIDE REDUCTASE; WARFARIN; XIMELAGATRAN; BENZIMIDAZOLE DERIVATIVE; BETA ALANINE; DABIGATRAN; MORPHOLINE DERIVATIVE; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE; THIOPHENE DERIVATIVE;

ACUTE LIVER FAILURE; ANTICOAGULANT THERAPY; ANTICOAGULATION; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CHADS2 SCORE; CONGESTIVE HEART FAILURE; CREATININE CLEARANCE; DEEP VEIN THROMBOSIS; DIABETES MELLITUS; DRUG TOLERABILITY; GENETIC PREDISPOSITION; HEART ATRIUM FIBRILLATION; HUMAN; HYPERTENSION; KIDNEY CLEARANCE; META ANALYSIS (TOPIC); PARTIAL THROMBOPLASTIN TIME; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RISK FACTOR; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; VENOUS THROMBOEMBOLISM; AGE; ANALOGS AND DERIVATIVES; ATRIAL FIBRILLATION; BLOOD; COMPLICATION; ORAL DRUG ADMINISTRATION; PRACTICE GUIDELINE; PRIMARY PREVENTION; PROCEDURES; STROKE;

ADMINISTRATION, ORAL; AGE FACTORS; ANTICOAGULANTS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; BRAIN ISCHEMIA; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; MORPHOLINES; PRACTICE GUIDELINES AS TOPIC; PRIMARY PREVENTION; PYRAZOLES; PYRIDONES; RISK FACTORS; STROKE; THIOPHENES;

EID: 84922393410     PISSN: 15701611     EISSN: 18756212     Source Type: Journal    
DOI: 10.2174/157016111203140518153503     Document Type: Article

References (79)

1. [1] Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004; 110: 1042-6.
2. [2] Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke1991; 22: 983-8.
3. [3] Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atria fibrillation and flutter in the United States. Am J Cardio 2009;104:1534-9.
4. [4] Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med 2002; 113: 359-64.
5. [5] Steger C, Pratter A, Martinek-Bregel M, et al. Stroke patients with atrial fibrillation have a worse prognosis than patients without: data from the Austrian Stroke registry. Eur Heart J 2004; 25: 1734-40.
6. [6] Hylek EM, Go AS, Chang Y, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 2003; 349: 1019-26.
7. [7] Hohnloser SH, Pajitnev D, Pogue J, et al. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol 2007; 50: 2156-61.
8. [8] Friberg L, Hammar N, Rosenqvist M. Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J 2010; 31: 967-75.
9. [9] Hughes M, Lip GY, Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost 2008; 99: 295-304.
10. [10] The Stroke Risk in Atrial Fibrillation Working Group. Independent predictors of stroke in patients with atrial fibrillation A systematic review. Neurology 2007; 69: 546-54.
11. [11] Nabauer M, Gerth Limbourg T, et al. The Registry of the German Competence NETwork on Atrial Fibrillation: patient characteristics and initial management. Europace 2009; 11: 423-34.
12. [12] Olesen JB, Fauchier L, Lane DA, Taillandier S, Lip GY. Risk factors for stroke and thromboembolism in relation to age amongst patients with atrial fibrillation: The Loire Valley Atrial Fibrillation Project Chest 2012; 141:147-53.
13. [13] Cleland JG, Swedberg K, Follath F, et al. The EuroHeartFailuresurvey programme--a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J 2003; 24: 442-63.
14. [14] Wang TJ, Larson MG, Levy D, et al. Temporal relations of atrial fibrillation and congestive heart failure and their joint influence on mortality: the FraminghamHeart Study. Circulation 2003; 107: 2920-5.
15. [15] Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001; 285: 2864-70.
16. [16] Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114: e257-354.
17. [17] Nieuwlaat R, Prins MH, Le Heuzey JY, et al. Prognosis, disease progression, and treatment of atrial fibrillation patients during 1 year: follow-up of the EuroHeartSurvey on atrial fibrillation. Eur Heart J 2008; 29: 1181-9.
18. [18] Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. 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 2010; 137: 263-72.
19. [19] Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillationexecutive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J 2006; 27: 1979-2030.
20. [20] Camm AJ, Kirchhof P, Lip GY, 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). Europace 2010; 12: 1360-420.
21. [21] Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51.
22. [22] Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med 2011; 365: 883-91.
23. [23] Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2011; 365: 981-92.
24. [24] Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 204S-233S.
25. [25] 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.
26. [26] Samsa GP, Matchar DB, Goldstein LB, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities. Arch Intern Med 2000; 160: 967-73.
27. [27] Connolly SJ, Pogue J, Eikelboom J, et al. Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation 2008; 118: 2029-37.
28. [28] Kalra L, Yu G, Perez I, Lakhani A, Donaldson N. Prospective cohort study to determine if trial efficacy of anticoagulation for stroke prevention in atrial fibrillation translates into clinical effectiveness. BMJ 2000; 320: 1236-9.
29. [29] 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 Auricul A. Eur Heart J 2011; 32: 2282-9.
30. [30] 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: 638-645.e4.
31. [31] Waldo AL, Becker RC, Tapson VF, Colgan KJ, NABOR Steering committee.Hospitalised patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol 2005; 46: 1729-36.
32. [32] Kirchhof P, Lip GYH, van Gelder IC, et al. Comprehensive risk reduction in patients with atrial fibrillation: Emerging diagnostic and therapeutic options. Executive summary of the report from the 3rd AFNET/EHRA consensus conference. Thromb Haemost 2011; 106: 1012-9.
33. [33] Olesen JB, Lip GY, Lindhardsen J, et al. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study. Thromb Haemost 2011; 106: 739-49.
34. [34] Huhtakangas J, Tetri S, Juvela S, Saloheimo P, Bode MK, Hillbom M. Effect of Increased Warfarin Use on Warfarin-Related Cerebral Hemorrhage: A Longitudinal Population-Based Study. Stroke 2011; 42: 2431-5.
35. [35] Mant J, Hobbs FD, Fletcher K, et al. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 2007; 370: 493-503.
36. [36] Garcia DA, Lopes RD, Hylek EM. New-onset atrial fibrillation and warfarininitiation: high risk periods and implications for new antithrombotic drugs. Thromb Haemost 2010; 104: 1099-105.
37. [37] Ahrens I, Lip GY, Peter K. New oral anticoagulant drugs in cardiovasculardisease. Thromb Haemost 2010; 104: 49-60.
38. [38] Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47: 285-95.
39. [39] Stangier J, Rathgen K, Stähle H, Gansser D, Roth W. 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.
40. [40] Stangier J, Stähle H, Rathgen K, Roth W, Shakeri-Nejad K. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, are not affected by moderate hepatic impairment. J Clin Pharmacol 2008; 48: 1411-9.
41. [41] 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.
42. [42] Oldgren J, Budaj A, Granger CB, et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J 2011; 32: 2781-9.
43. [43] Lip GY, Lane DA. Does warfarin for stroke thromboprophylaxis protect against MI in atrial fibrillation patients? Am J Med 2010; 123: 785-9.
44. [44] Cairns JA, Connolly S, McMurtry S, Stephenson M, Talajic M. CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol 2011; 27: 74-90.
45. [45] Wallentin L, Yusuf S, Ezekowitz MD, et al. 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.
46. [46] Diener HC, Connolly SJ, Ezekowitz MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RELY trial. Lancet Neurol 2010; 9: 1157-63.
47. [47] 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.
48. [48] 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.
49. [49] Zhang QL, Rothenbacher D. Prevalence of chronic kidney disease in population-based studies: systematic review. BMC Public Health 2008; 8: 117.
50. [50] http://www.scottishmedicines.org.uk/files/advice/dabigatran_Pradaxa_FINAL_August_2011_Amended_05.09.11_for_website.pdf
51. [51] http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000829/WC500041059.pdf
52. [52] Beasley BN, Unger EF, Temple R. Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med 2011; 364: 1788-90.
53. [53] Khoo CW, Tay KH, Shansila E, Lip GY. Novel oral anticoagulants. Int J Clin Pract 2009; 63: 630-41.
54. [54] Amadeus Investigators, Bousser MG, Bouthier J, et al. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, openlabel, non-inferiority trial. Lancet 2008; 371: 315-21.
55. [55] 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.
56. [56] Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M. 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.
57. [57] Weinz C, Schwarz T, Kubitza D, Mueck W, Lang D. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2009; 37: 1056-64.
58. [58] Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-86.
59. [59] EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510.
60. [60] Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in Patients with a Recent Acute Coronary Syndrome. N Engl J Med 2012; 366: 9-19.
61. [61] Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renalimpairment. Eur Heart J 2011; 32: 2387-94.
62. [62] Hacke W, Hankey G, for the ROCKET-AF Committees. Rivaroxaban versus warfarin in patients with AF and prior cerebrovascular disease: Results from the ROCKET-AF trial. 201 European Stroke Conference; May 24-27 2011; Hamburg, Germany. http://www.theheart.org/article/1232007.do
63. [63] Raghavan N, Frost CE, Yu Z, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos 2009; 37: 74-81.
64. [64] Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806-17.
65. [65] Eckman MH, Singer DE, Rosand J, Greenberg SM. Moving the tipping point: the decision to anticoagulate patients with atrial fibrillation. Circ Cardiovasc Qual 2011; 4: 14-21.
66. [66] Banerjee A, Lane DA, Torp-Pedersen C, Lip GY. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study. Thromb Haemost 2011; 107: 584-9.
67. [67] Legrand M, Mateo J, Aribaud A, et al. The Use of Dabigatran in Elderly Patients. Arch Intern Med 2011; 171: 1285-6.
68. [68] 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.
69. [69] van Ryn J, Ruehl H, Priepke H, Hauel N, Wienen W. Reversibility of the anticoagulant effect of high doses of the direct thrombin inhibitor dabigatran, by recombinant factor VIIa or activated prothrombin complex concentrate. Haematologica 2008; 93: 148 Abs.0370.
70. [70] Ogawa S, Aizawa Y, Atarashi H, Inoue H, Okumura K, Kamakura S. Guidelines for pharmacotherapy of atrial fibrillation. Circ J 2008; 72: 1639-58.
71. [71] Sato H, Ishikawa K, Kitabatake A, et al. Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan atrial fibrillation stroke trial. Stroke 2006; 37: 447-51.
72. [72] Atarashi H, Inoue H, Okumura K, Yamashita T, Kumagai N, Origasa H. J-RHYTHM Registry Investigators. Present status of anticoagulation treatment in Japanese patients with atrial fibrillation: a report from the J-RHYTHM Registry. Circ J 2011; 75: 1328-33.
73. [73] ACTIVE Investigators, Connolly SJ, Pogue J, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009; 360: 2066-78.
74. [74] Lip GY, Andreotti F, Fauchier L, et al. Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis. Europace 2011; 13: 723-46.
75. [75] Alexander JH, Lopes RD, James S, et al. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med 2011; 365: 699-708.
76. [76] Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart 1999; 82: 547-54.
77. [77] Healey JS, Crystal E, Lamy A, et al. Left Atrial Appendage Occlusion Study (LAAOS): results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke. Am Heart J2005; 150: 288-293.
78. [78] García-Fernández MA, Pérez-David E, Quiles J, et al. Role of left atrial appendage obliteration in stroke reduction in patients with mitral valve prosthesis: a transesophageal echocardiographic study. J Am Coll Cardiol 2003; 42: 1253-8.
79. [79] Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: A randomised noninferiority trial. Lancet 2009; 374: 534-2.