Статья
АНТИТРОМБОТИЧЕСКАЯ ТЕРАПИЯ ПРИ ФИБРИЛЛЯЦИИ ПРЕДСЕРДИЙ: СОВРЕМЕННЫЕ ПОДХОДЫ И БЛИЖАЙШИЕ ПЕРСПЕКТИВЫ
Освещены современные данные и перспективы антитромботической терапии у больных фибрилляцией предсердий (ФП). Приведены данные последних отечественных и зарубежных рекомендаций по профилактике тромбоэмболических осложнений при ФП. Отдельно рассмотрены новые препараты для проведения оральной антикоагулянтной терапии, представлены сведения об их эффективности, безопасности и возможностях использования.
1. Camm A.J., Kirchhof P., Lip G.Y. 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;12:1360–1420.
2. Fuster V., Rydén L.E., Cannom D.S. et al. 2011 ACCF/AHA/HRS Focused Updates Incorporated Into the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011, 123:e269-e367.
3. National guidelines for diagnosis and treatment of atrial fibrillation. Kardiovaskulyarnaya terapiya i pro-filaktika 2005; 4(4) suppl 1: 1-36. Russian (Национальные рекомендации по диагностике и лечению фибрилляции предсердий. Кардиоваскулярная терапия и профилактика 2005; 4(4) приложение 1: 1-36).
4. Heeringa J., van der Kuip D.A., Hofman A. et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006;27:949–953.
5. Feinberg W.M., Blackshear J.L., Laupacis A. et al. Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications. Arch Intern Med 1995;155: 469–473.
6. Go A.S., Hylek E.M., Phillips K.A. et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285:2370–2375.
7. Benjamin E.J., Levy D., Vaziri S.M. et al. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA 1994;271(11):840-844.
8. Veronique L.R., Alan S.G., Donald M.L.-J. et al. Heart Disease and Stroke Statistics: 2011 Update: A Report From the American Heart Association. Circulation 2011;123;e18-e209.
9. Hart R.G., Halperin J.L. Atrial fibrillation and stroke: concepts and controversies. Stroke 2001;32(3): 803-8.
10. Wolf P.A., Abbott R.D., Kannel W.B. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988.
11. Friberg L., Hammar N., Rosenqvist M. Stroke in paroxysmal atrial fibrillation: report from the Stock-holm Cohort of Atrial Fibrillation. Eur Heart J 2010;31:967–975.
12. Hohnloser S.H., 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(22): 2156 – 2161.
13. Scholten M.F., Thornton A.S., Mekel J.M. et al. Anticoagulation in atrial fibrillation and flutter. Europace 2005;7(5):492-9.
14. Dulli D.A., Stanko H., Levine R.L. Atrial fibrillation is associated with severe acute ischemic stroke. Neuroepidemiology 2003;22:118–123.
15. Lin H.J., Wolf P.A., Kelly-Hayes M. et al. Stroke severity in atrial fibrillation. The Framingham Study. Stroke 1996;27:1760–1764.
16. Nieuwlaat R. et al. European Heart Survey Investigators. Atrial fibrillation management: a prospective survey in ESC member countries: the Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2005;26:2422-2434.
17. Penado S., Cano M., Acha O. et al. Atrial fibrillation as a risk factor for stroke recurrence. Am J Med 2003;114:206–210.
18. Watson T., Shantsila E., Lip G.Y. Mechanisms of thrombogenesis in atrial fibrillation: Virchow’s triad revisited. Lancet 2009;373:155–166.
19. Odell J.A., Blackshear J.L., Davies E. et al. Thoracoscopic obliteration of the left atrial appendage: potential for stroke reduction? Ann Thorac Surg 1996;61:565e9.
20. Cianfrocca C., Loricchio M.L., Pelliccia F. et al. C-reactive protein and left atrial appendage velocity are independent determinants of the risk of thrombogenesis in patients with atrial fibrillation. Int J Car-diol 2010;142(1):22-28.
21. Kumagai K., Fukunami M., Ohmori M. et al. Increased intracardiovascular clotting in patients with chronic atrial fibrillation, J. Am. Coll. Cardiol. 1990;16:377-80.
22. Choudhury A., Chung I., Blann A.D. et al. Elevated platelet microparticle levels in nonvalvular atrial fibrillation: relationship to p-selectin and antithrombotic therapy. Chest 2007; 131: 809-815
23. Kamath S., Blann A.D., Chin B.S. et al. A study of platelet activation in atrial fibrillation and the effects of antithrombotic therapy. Eur Heart J 2002;23:1788-1795.
24. De Caterina R., Husted S., Wallentin L. et al. Anticoagulants in heart disease: current status and perspectives. Eur Heart J. 2007;28(7):880-913.
25. Gage B.F., Waterman A.D., Shannon W. et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285:2864–2870.
26. Lip G.Y., Nieuwlaat R., Pisters R. et al. 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;137:263–272.
27. Hart R.G., Pearce L.A., Aguilar M.I. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med 2007; 146(12): 857 - 867.
28. Andersen L.V., Vestergaard P., Deichgraeber P. et al. Warfarin for the prevention of systemic embolism in patients with non-valvular atrial fibrillation: a metaanalysis. Heart 2008 94: 1607-1613.
29. The ACTIVE Writing Group. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 2006; 367(9526): 1903 - 1912.
30. Yavelov I.S., Moiseev S.V. Antithrombotic therapy in current treatment recommendations of atrial fibrillation. Klinicheskaya farmakologiya i terapiya 2011;20(3), 64-74. Russian (Явелов И.С., Моисеев С.В. Антитромботическая терапия в современных рекомендациях по лечению фибрилляции предсердий. Клиническая фармакология и терапия 2011;20(3), 64-74).
31. Gage B., Yan Y., Milligan P. et al. Clinical classification schemes for predicting hemorrhage: Results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J 2006;151(3):713-9.
32. Pisters R., Lane D.A., Nieuwlaat R. et al. A novel userfriendly score (HAS-BLED) to assess one-year risk of major bleeding in atrial fibrillation patients: The Euro Heart Survey. Chest 2010;138(5): 1093-100.
33. Ansell J., Hirsh J., Poller L. et al. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126:204S– 233S.
34. Holbrook A.M., Pereira J.A., Labiris R. et al. Systematic overview of warfarin and its drug and food interactions. Arch Intern Med 2005;165:1095–1106.
35. Gilyarov M.Yu., Sulimov V.A. Antithrombotic therapy in atrial fibrillation: old problems and new solutions. Rational Pharmacother Cardiol 2010;6(1):84-88. Russian (Гиляров М.Ю., Сулимов В.А. Антитромботическая терапия при фибрилляции предсердий: старые проблемы и новые решения. РФК 2010; 6(1): 84-88).
36. Taggar J.S., Lip G.Y. Anticoagulation in atrial fibrillation: the trials and tribulations of keeping within therapeutic range. Curr Med Res Opin 2008;24:1455–1458.
37. Hirsh J., Guyatt G., Albers G.W. et al. Antithrombotic and thrombolytic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:110S– 112S.
38. Connolly S.J., 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.
39. Baker W.L., Cios D.A., Sander S.D. et al. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm 2009; 15(3): 244-52.
40. The ACTIVE Investigators. Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation. N Engl J Med 2009;360(20):2066-2078.
41. Gilyarov M.Yu., Sulimov V.A. Antithrombotic therapy in atrial fibrillation: new data and new horizons. Rational Pharmacother Cardiol 2011;7(1):75-81. Russian (Гиляров М.Ю., Сулимов В.А. Антитромботическая терапия при фибрилляции предсердий: новые данные и новые горизонты. РФК 2011;7(1):75-81).
42. Vavilova T.V., Vorob'eva Iu.K., Beliavskaia O.O., Bel'ko E.A. Models of organization of work with patients receiving warfarin for prevention of thromboembolic complications. Kardiologiia. 2011;51(4):79-83. Russian (Вавилова Т.В., Воробьева Ю.К., Белявская О.О. и др. Модели организации работы с больными, получающими варфарин для профилактики тромбоэмболических осложнений. Кардиология 2011; 4:79-83).
43. Birman-Deych E., Radford M.J., Nilasena D.S. et al. Use and effectiveness of warfarin in Medicare beneficiaries with atrial fibrillation. Stroke 2006;37:1070-4.
44. Hylek E.M., Evans-Molina C., Shea C. et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007;115:2689-96.
45. Heneghan C., Alonso-Coello P., Garcia-Alamino J.M. et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367:404-411.
46. Preobrazhenskiĭ D.V., Sidorenko B.A., Batyraliev T.A., Nekrasova N.I. Drug prevention of pulmonary embolism in orthopedic practice: traditional and novel approaches. Kardiologiia. 2011;51(5):62-9. Russian (Преображенский Д.В., Сидоренко Б.А., Батыралиев Т.А и др. Медикаментозная профилактика тромбоэмболии легочной артерии в ортопедической практике: традиционные и новые подходы. Кардиология 2011;5:62-69).
47. Steffel J., Braunwald E. Novel oral anticoagulants: focus on stroke prevention and treatment of venous thrombo-embolism. Eur Heart J. doi:10.1093/eurheartj/ehr052.
48. Turpie A.G. New oral anticoagulants in atrial fibrillation. Eur Heart J. 2007;29:155-165.
49. Ellis D.J., Usman M.H., Milner P.G. et al. The first evaluation of a novel vitamin K antagonist, tecarfarin (ATI-5923), in patients with atrial fibrillation. Circulation 2009; 120:1029-1035.
50. Lee C.J., Ansell J.E. Direct Thrombin Inhibitors. Br J Clin Pharmacol. 2011; 1365-2125.
51. Di Nisio M., Middeldorp S., Buller H.R. Direct thrombin inhibitors. N Engl J Med 2005;353: 1028–1040.
52. Sarich T.C., Wolzt M., Eriksson U.G. et al. Effects of ximelagatran, an oral direct thrombin inhibitor, r-hirudin and enoxaparin on thrombin generation and platelet activation in healthy male subjects. J Am Coll Cardiol 2003;41:557-64.
53. Olsson S.B. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with war-farin in patients with non-valvular atrial fibrillation (SPORTIF III): randomized controlled trial. Lancet. 2003;362:1691-1698.
54. Weitz J.I., Bates S.M. New anticoagulants. J Thromb Haemost 2005;3:1843–1853.
55. Albers G.W., Diener H.C., Frison L. et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA. 2005;29:690-698.
56. Fiessinger J.N., Huisman M.V., Davidson B.L. et al. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized trial. JAMA 2005;293:681–689.
57. Connolly S.J., Ezekowitz M.D., Yusuf S. et al. RE-LY Steering Committee and Investigators Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139–1151.
58. 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 Pharma-col 2007;64:292–303.
59. Blech S., Ebner T., Ludwig-Schwellinger E. et al. The metabolism and disposition of the oral direct throm-bin inhibitor, dabigatran, in humans. Drug Metab Dispos 2008;36(2):386-99.
60. Eikelboom J.W., Wallentin L., Connolly S.J. 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(21):2363-72.
61. Oldgren J., Alings M., Darius H. et al. Dabigatran versus warfarin in atrial fibrillation patients with low, moderate and high CHADS2 score: a RE-LY subgroup analysis. J. Am. Coll. Cardiol. 2010; 55: A1. E2.
62. Connolly S.J., Ezekowitz M.D., Yusuf S. et al. Newly identified events in the RE-LY trial. N Engl J Med 2010;363:1875–1876.
63. Ezekowitz M.D., Wallentin L., Connolly S.J. et al.; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010;122:2246-2253.
64. Nagarakanti R., Ezekowitz M.D., Oldgren J. et al. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation 2011; 123(2):131-6.
65. Wann L.S., Curtis A.B., Ellenbogen K.A. et al. 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(10):1144-50.
66. Beasley B.N., Unger E.F., Temple R. Anticoagulant options – why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med. 2011;364:1788-1790.
67. Steffel J., Tanner F.C. Direct thrombin inhibitors in atrial fibrillation reloaded. Eur Heart J. 2009;30(23):2897-907.
68. Lip G.Y., Rasmussen L.H., Olsson S.B. et al. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: a randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists. Eur Heart J. 2009;30: 2897–2907.
69. Hylek E.M. Therapeutic potential of oral factor Xa inhibitors. N Engl J Med. 2010;363:2559-61.
70. Perzborn E., Roehrig S., Straub A. et al. Rivaroxaban: a new oral factor Xa inhibitor. Arterioscler Thromb Vasc Biol 2010;30:376–381.
71. The Executive Steering Committee on behalf of the ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159:340-347.
72. Moiseev V.S. Rivaroxaban — a new factor Xa inhibitor straight for oral administration. Klinicheskaya farmakologiya i terapiya 2010, 19(4), 11-16. Russian (Моисеев В.С. Ривароксабан – новый прямой ингибитор фактора Xа для приема внутрь. Клиническая фармакология и терапия 2010, 19(4), 11-16).
73. Wong P.C., Crain E.J., Xin B. et al. Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. J Thromb Haemost 2008;6:820–829.
74. Raghavan N., Frost C.E., Yu Z. et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos 2009;37:74–81.
75. Connolly S.J., Eikelboom J., Joyner C. et al. Apixaban in Patients with Atrial Fibrillation. N Engl J Med 2011;364:806-17.
76. Lopes R.D., Alexander J.H., Al-Khatib S.M. et al. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J 2010;159:331–339.
77. Bristol-Myers Squibb. Eliquis (apixaban) meets primary and key secondary endpoints in phase 3 ARISTOTLE study. June 22, 2011. Available at http://www.bms.com/news/press_releases/pages/default.aspx?RSSLink=http://www.businesswire.com/news/bms/20110622006923/en &t=634444126192849398. Date of access: 25.10.2011.
78. Ruff C.T., Giugliano R.P., Antman E.M. et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J 2010;160:635–641.
79. Turpie A.G., Bauer K.A., Davidson B.L. et al.; EXPERT Study Group. A randomized evaluation of be-trixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT). J Thromb Haemost. 2009;101:68-76.
80. Ansell J. Factor Xa or thrombin: is factor Xa a better target? J Thromb Haemost 2007;5 (suppl 1):60-64.
81. Agnelli G., Haas S., Ginsberg J.S. et al. A phase II study of the oral factor Xa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement. J Thromb Haemost. 2007;5:746-53.
82. Shah S.V., Gage B.F. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation 2011,123:2562-2570.
83. Freeman J.V., Zhu R.P., Owens D.K. et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011;154:1-11.
84. Sorensen S.V., Kansal A.R., 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.
85. Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin (EXPLORE-Xa). Available on: http://www.clinicaltrials.gov/ct2/show/NCT00742859. Date of access 25.10.2011.