Тромботические и геморрагические осложнения у больных фибрилляцией предсердий, перенесших плановое чрескожное коронарное вмешательство
Тромботические и геморрагические осложнения у больных фибрилляцией предсердий, перенесших плановое чрескожное коронарное вмешательство
Кривошеева Е.Н., Кропачева Е.С., Панченко Е.П., Самко А.Н. Тромботические и геморрагические осложнения у больных фибрилляцией предсердий, перенесших плановое чрескожное коронарное вмешательство. Терапевтический архив. 2019; 91 (9): 38–46. DOI: 10.26442/00403660.2019.09.000297
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Аннотация
Цель исследования – изучить эффективность и безопасность сниженной дозы прямых пероральных антикоагулянтов (ППАКГ) в составе тройной антитромботической терапии у больных фибрилляцией предсердий (ФП), перенесших плановое чрескожное коронарное вмешательство (ЧКВ), а также выявить факторы, ассоциированные с выбором такой стратегии.
Материалы и методы. Исследование представляет собой анализ когорты больных ФП, которым успешно выполнено плановое ЧКВ и назначены ППАКГ в составе тройной антитромботической терапии (ТАТ). Влияние приема сниженной дозы ППАКГ в составе ТАТ на частоту комбинированной конечной точки эффективности (острый коронарный синдром, ишемический инсульт, венозные тромбоэмболические осложнения, сердечно-сосудистая смерть и усугубление клиники стенокардии/потребность в проведении не запланированного ЧКВ), а также конечной точки безопасности (геморрагические осложнения BARC 2–5) оценивали с помощью критерия Log-Rank.
Результаты. Всего в исследование включено 124 пациента (69,4% женщины, средний возраст 69,9±8,2 года). Медиана суммы баллов по шкале CHA2DS2-VASc составила 5, медиана индекса Charlson – 7. Половине (52%) из включенных в исследование пациентов лечащие врачи назначали ППАКГ в сниженных дозах. По результатам множественной регрессии сумма баллов по шкале CHA2DS2-VASc ≥5 оказалась независимым предиктором назначения сниженной дозы ППАКГ больным ФП, нуждавшимся в приеме ТАТ (β=0,32, p=0,0328). Медиана длительности наблюдения составила 11 мес. За этот период зарегистрировано 17 неблагоприятных тромботических событий, кровотечения BARC 2–5 возникли у 27 пациентов. В группе больных, получавших ППАКГ в сниженной дозе, доля пациентов без тромботических осложнений была достоверно выше, чем в группе полной дозы ППАКГ (0,79 против 0,93, Log-Rank p= 0,0292). Частота кровотечений BARC 2–5 у пациентов, получавших полную и сниженную дозы ППАКГ в составе ТАТ, достоверно не различалась (0,78 против 0,75, Log-Rank p=0,06742).
Заключение. Назначение сниженной дозы ППАКГ в составе ТАТ у больных ФП, подвергнутых ЧКВ, ассоциировалось с достоверным увеличением частоты всех тромботических событий по сравнению с пациентами, получавшими полную дозу антикоагулянтов, при сопоставимом числе геморрагических осложнений.
Ключевые слова: прямые пероральные антикоагулянты, тройная антитромботическая терапия, фибрилляция предсердий, чрескожные коронарные вмешательства, риск сердечно-сосудистых осложнений.
Materials and methods. The study is a cohort analysis of AF patients with AF, who successfully underwent elective PCI and assigned DOACs as part of triple antithrombotic therapy (TAT).Influence of a reduced DOACs dose as a part of TAT on the frequency of thecomposite efficacy endpoint (acute coronary syndrome, ischemic stroke, venous thromboembolic events, cardiovascular death and angina pectoris aggravation/need for unplanned PCI) and safety endpoint (hemorrhagic complications BARC types 2–5) were assessed using the Log-Rank criterion.
Results. The study included 124 pts (69.4% women, mean aged 69±8.2 years). Themedian total score CHA2DS2-VASc was 5, the median of the Charlson index composed 7. Half (52%) of AF patients with high risk of thrombotic events after elective PCI received reduced-DOACs dose. Median follow up period was 11.0 month. 17 adverse thrombotic events were recorded during this period, BARC 2–5 bleedings occurred in 27 patients. Reduced DOACs doses in AF patients undergoing PCI were associated with significant increase of thrombotic events during follow up period compared to patients received full DOACs doses (0.79 vs 0.93, Log-Rank p=0.0292). Patients, who received full and reduced DOAC doses, were comparable in the frequency of BARC 2–5 bleedings (0.78 vs 0.75, Log-Rank p=0.06742).
Conclusions. The administration of a reduced DOACs dose as a part of TAT in patients with AF, who underwent PCI, was associated with significant increase in the incidence of all thrombotic events, compared to patients, who received full dose of anticoagulants. The number of hemorrhagic complications was comparable.
Keywords: direct oral anticoagulants, triple antithrombotic therapy, atrial fibrillation, percutaneous coronary interventions, risk of cardiovascular complications.
Материалы и методы. Исследование представляет собой анализ когорты больных ФП, которым успешно выполнено плановое ЧКВ и назначены ППАКГ в составе тройной антитромботической терапии (ТАТ). Влияние приема сниженной дозы ППАКГ в составе ТАТ на частоту комбинированной конечной точки эффективности (острый коронарный синдром, ишемический инсульт, венозные тромбоэмболические осложнения, сердечно-сосудистая смерть и усугубление клиники стенокардии/потребность в проведении не запланированного ЧКВ), а также конечной точки безопасности (геморрагические осложнения BARC 2–5) оценивали с помощью критерия Log-Rank.
Результаты. Всего в исследование включено 124 пациента (69,4% женщины, средний возраст 69,9±8,2 года). Медиана суммы баллов по шкале CHA2DS2-VASc составила 5, медиана индекса Charlson – 7. Половине (52%) из включенных в исследование пациентов лечащие врачи назначали ППАКГ в сниженных дозах. По результатам множественной регрессии сумма баллов по шкале CHA2DS2-VASc ≥5 оказалась независимым предиктором назначения сниженной дозы ППАКГ больным ФП, нуждавшимся в приеме ТАТ (β=0,32, p=0,0328). Медиана длительности наблюдения составила 11 мес. За этот период зарегистрировано 17 неблагоприятных тромботических событий, кровотечения BARC 2–5 возникли у 27 пациентов. В группе больных, получавших ППАКГ в сниженной дозе, доля пациентов без тромботических осложнений была достоверно выше, чем в группе полной дозы ППАКГ (0,79 против 0,93, Log-Rank p= 0,0292). Частота кровотечений BARC 2–5 у пациентов, получавших полную и сниженную дозы ППАКГ в составе ТАТ, достоверно не различалась (0,78 против 0,75, Log-Rank p=0,06742).
Заключение. Назначение сниженной дозы ППАКГ в составе ТАТ у больных ФП, подвергнутых ЧКВ, ассоциировалось с достоверным увеличением частоты всех тромботических событий по сравнению с пациентами, получавшими полную дозу антикоагулянтов, при сопоставимом числе геморрагических осложнений.
Ключевые слова: прямые пероральные антикоагулянты, тройная антитромботическая терапия, фибрилляция предсердий, чрескожные коронарные вмешательства, риск сердечно-сосудистых осложнений.
________________________________________________
Materials and methods. The study is a cohort analysis of AF patients with AF, who successfully underwent elective PCI and assigned DOACs as part of triple antithrombotic therapy (TAT).Influence of a reduced DOACs dose as a part of TAT on the frequency of thecomposite efficacy endpoint (acute coronary syndrome, ischemic stroke, venous thromboembolic events, cardiovascular death and angina pectoris aggravation/need for unplanned PCI) and safety endpoint (hemorrhagic complications BARC types 2–5) were assessed using the Log-Rank criterion.
Results. The study included 124 pts (69.4% women, mean aged 69±8.2 years). Themedian total score CHA2DS2-VASc was 5, the median of the Charlson index composed 7. Half (52%) of AF patients with high risk of thrombotic events after elective PCI received reduced-DOACs dose. Median follow up period was 11.0 month. 17 adverse thrombotic events were recorded during this period, BARC 2–5 bleedings occurred in 27 patients. Reduced DOACs doses in AF patients undergoing PCI were associated with significant increase of thrombotic events during follow up period compared to patients received full DOACs doses (0.79 vs 0.93, Log-Rank p=0.0292). Patients, who received full and reduced DOAC doses, were comparable in the frequency of BARC 2–5 bleedings (0.78 vs 0.75, Log-Rank p=0.06742).
Conclusions. The administration of a reduced DOACs dose as a part of TAT in patients with AF, who underwent PCI, was associated with significant increase in the incidence of all thrombotic events, compared to patients, who received full dose of anticoagulants. The number of hemorrhagic complications was comparable.
Keywords: direct oral anticoagulants, triple antithrombotic therapy, atrial fibrillation, percutaneous coronary interventions, risk of cardiovascular complications.
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2. Connolly S, Ezekowitz M, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2009;361(12):1139-51. doi: 10. 1056/nejmoa0905561
3. Granger C, Alexander J, McMurray J, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2011;365(11):981-92. doi:10. 1056/nejmoa1107039
4. Patel M, Mahaffey K, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. New England J Medicine. 2011;365(10):883-91. doi: 10.1056/ nejmoa1009638
5. Giugliano R, Ruff C, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2013;369(22):2093-104. doi:10.1056/nejmoa1310907
6. [Diagnostika i lechenie fibrillyatsii predserdii. Rekomendatsii VNOK, RKO i ASSKh. Accessed March 3, 2019 (In Russ.)]. https://vnoa.ru/upload/ edition_ june2017/4_fp.pdf
7. Steffel J, Verhamme P, Potpara T, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-93. doi: 10.1093/eurheartj/ehy136
8. Lip G, Windecker S, Huber K, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J. 2014;35(45):3155-79. doi: 10.1093/eurheartj/ehu298
9. Valgimigli M, Bueno H, Byrne R, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2017;39(3):213-60. doi: 10.1093/eurheartj/ehx419
10. Neumann F, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10. 1093/eurheartj/ehy394
11. Hart R, Pearce L, Aguilar M. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med. 2007;146(12):857. doi: 10.7326/0003-4819-146-12-200706190-00007
12. 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. The Lancet. 2006;367(9526):1903-12. doi: 10.1016/s0140-6736(06)68845-4
13. Connolly S, Eikelboom J, Joyner C, et al. Apixaban in Patients with Atrial Fibrillation. New England J Medicine. 2011;364(9):806-17. doi: 10.1056/nejmoa 1007432
14. Bogacki P, Kabłak-Ziembicka A, Bryniarski K, et al. Triple anticoagulation therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention – real life assessment. Advances in Interventional Cardiology. 2016;4:303-13. doi: 10.5114/aic.2016.63629
15. Sørensen R, Hansen M, Abildstrom S, et al. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. The Lancet. 2009;374(9706):1967-74. doi: 10.1016/s0140-6736 (09)61751-7
16. Hansen M, Sørensen R, Clausen M, et al. Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation. Arch Intern Med. 2010;170(16). doi: 10.1001/archinternmed.20 10.271
17. Angiolillo D, Goodman S, Bhatt D, et al. Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention. Circulation. 2018;138(5):527-36. doi: 10. 1161/circulationaha.118.034722
18. Gibson C, Mehran R, Bode C, et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. New England J Medicine. 2016;375(25):2423-34. doi: 10.1056/nejmoa1611594
19. Cannon C, Bhatt D, Oldgren J, et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. New England J Medicine. 2017; 377(16):1513-24. doi: 10.1056/nejmoa1708454
20. Clemens A, Noack H, Ferreira J, Connolly S, Yusuf S, Lip G. Patient outcomes using the European label for dabigatran. Thromb Haemost. 2014;111(05):933-42. doi: 10.1160/th13-09-0734
21. Steinberg B, Shrader P, Pieper K, et al. Frequency and Outcomes of Reduced Dose Non–Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II). J Am Heart Assoc. 2018;7(4). doi: 10.1161/jaha.117.007633
22. [Panchenko EP. Profilaktika trombojembolicheskih oslozhnenij u pacientov s fibrilljaciej predserdij posle stentirovanija koronarnyh arterij. Aterotromboz. 2015;(1):2-15. Accessed March 3, 2019 (In Russ.)]. https://www.aterotromboz.ru/jour/article/view/2/2
23. [Shahmatova OO, Panchenko EP. Kak snizit' risk krovotechenija pri chreskozhnyh koronarnyh vmeshatel'stvah u pacientov s fibrilljaciej predserdij: uroki randomizirovannyh issledovanij i novye klinicheskie rekomendacii. Aterotromboz. 2018;(1):93-106 (In Russ.)]. doi: 10.21518/2307-1109-2018-1-93-106
24. Mehran R, Rao S, Bhatt D, et al. Standardized Bleeding Definitions for Cardiovascular Clinical Trials. Circulation. 2011;123(23):2736-47. doi: 10.1161/ circulationaha.110.009449
25. Charlson M, Pompei P, Ales K, MacKenzie C. A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8
26. Morisky D, Green L, Levine D. Concurrent and Predictive Validity of a Self-reported Measure of Medication Adherence. Med Care. 1986;24(1):67-74. doi: 10.1097/00005650-198601000-00007
27. McIntyre W, Conen D, Olshansky B, et al. Stroke-prevention strategies in North American patients with atrial fibrillation: The GLORIA-AF registry program. Clin Cardiol. 2018;41(6):744-51. doi:10.1002/clc.22936
28. Steinberg B, Gao H, Shrader P, et al. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017;194:132-40. doi: 10.1016/j.ahj.2017.08.011
29. Piran S, Schulman S, Panju M, Pai M. Oral anticoagulant dosing, administration, and storage: a cross-sectional survey of Canadian health care providers. J Thromb Thrombolysis. 2017;45(1):180-5. doi: 10.1007/s11239-017-1585-y
30. Larock A, Mullier F, Sennesael A, et al. Appropriateness of Prescribing Dabigatran Etexilate and Rivaroxaban in Patients With Nonvalvular Atrial Fibrillation. Annals of Pharmacotherapy. 2014;48(10):1258-68. doi: 10.1177/ 1060028014540868
31. Basaran O, Filiz Basaran N, Cekic E, et al. PRescriptiOn PattERns of Oral Anticoagulants in Nonvalvular Atrial Fibrillation (PROPER study). Clinical and Applied Thrombosis/Hemostasis. 2015;23(4):384-91. doi: 10.1177/1076029615 614395
32. Pattullo C, Barras M, Tai B, McKean M, Donovan P. New oral anticoagulants: appropriateness of prescribing in real-world setting. Intern Med J. 2016;46(7):812-8. doi: 10.1111/imj.13118
33. Belen E, Canbolat I, Bayyigit A, Helvaci A, Pusuroglu H, Kilickesmez K. A new gap in the novel anticoagulants’ era. Blood Coagulation & Fibrinolysis. 2015;26(7):793-7. doi: 10.1097/mbc.0000000000000349
34. Barra M, Fanikos J, Connors J, Sylvester K, Piazza G, Goldhaber S. Evaluation of Dose-Reduced Direct Oral Anticoagulant Therapy. Am J Med. 2016;129(11):1198-204. doi: 10.1016/j.amjmed.2016.05.041
35. Shrestha S, Baser O, Kwong W. Effect of Renal Function on Dosing of Non–Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation. Annals of Pharmacotherapy. 2017;52(2):147-53. doi: 10.1177/1060028017728295
36. Lavoie K, Turgeon M, Brais C, et al. Inappropriate dosing of direct oral anticoagulants in patients with atrial fibrillation. J Atr Fibrillation. 2016;9(4). doi: 10.4022/jafib.1478
37. Ruiz Ortiz M, Muñiz J, Raña Míguez P, et al. Inappropriate doses of direct oral anticoagulants in real-world clinical practice: prevalence and associated factors. A subanalysis of the FANTASIIA Registry. EP Europace. 2017;20(10):1577-83. doi: 10.1093/europace/eux316
38. Sato T, Aizawa Y, Fuse K, et al. The Comparison of Inappropriate-Low-Doses Use among 4 Direct Oral Anticoagulants in Patients with Atrial Fibrillation: From the Database of a Single-Center Registry. J Stroke and Cerebrovascular Diseases. 2018;27(11):3280-8. doi: 10.1016/j.jstrokecerebrovasdis.2018.07.028
39. Okumura Y, Yokoyama K, Matsumoto N, et al. Current use of direct oral anticoagulants for atrial fibrillation in Japan: Findings from the SAKURA AF Registry. J Arrhythm. 2017;33(4):289-96. doi: 10.1016/j.joa.2016.11.003
40. Yamashita Y, Uozumi R, Hamatani Y, et al. Current Status and Outcomes of Direct Oral Anticoagulant Use in Real-World Atrial Fibrillation Patients – Fushimi AF Registry. Circulation J. 2017;81(9):1278-85. doi: 10.1253/circj.cj-16-1337
41. Dewilde W, Oirbans T, Verheugt F, et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. The Lancet. 2013;381(9872):1107-15. doi: 10.1016/s0140-6736(12)62177-1
42. Abstract 10999: Outcomes Associated With Under-Dosing of Rivaroxaban for Management of Non-Valvular Atrial Fibrillation in Real World Clinical Setting From the XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients With Atrial Fibrillation). Circulation. 2018;138:A 10999Ahajournals.org. https://www.ahajournals.org/doi/abs/10.1161/circ.138. suppl_1.10999?af=R
43. Undas A. Fibrin clot properties and their modulation in thrombotic disorders. Thromb Haemost. 2014;112(07):32-42. doi: 10.1160/th14-01-0032
44. January C, Wann L, Alpert J, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):2246-80. doi: 10.1016/j.jacc.2014.03.021
45. [Kropacheva ES, Zemljanskaja OA, Panchenko EP, Dobrovol'skij AB, Krivosheeva EN. Bezopasnost' dlitel'noj terapii varfarinom: chastota krovotechenij i klinicheskie prediktory ih razvitija (rezul'taty prospektivnogo 15-letnego nabljudenija). Aterotromboz. 2017;(1):145-62 (In Russ.)]. doi: 10.21518/ 2307-1109-2017-1-145-162
2. Connolly S, Ezekowitz M, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2009;361(12):1139-51. doi: 10. 1056/nejmoa0905561
3. Granger C, Alexander J, McMurray J, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2011;365(11):981-92. doi:10. 1056/nejmoa1107039
4. Patel M, Mahaffey K, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. New England J Medicine. 2011;365(10):883-91. doi: 10.1056/ nejmoa1009638
5. Giugliano R, Ruff C, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2013;369(22):2093-104. doi:10.1056/nejmoa1310907
6. Диагностика и лечение фибрилляции предсердий. Рекомендации ВНОК, РКО и АССХ 2017. Ссылка активна на 03.03.2019 [Diagnostika i lechenie fibrillyatsii predserdii. Rekomendatsii VNOK, RKO i ASSKh. Accessed March 3, 2019 (In Russ.)]. https://vnoa.ru/upload/ edition_ june2017/4_fp.pdf
7. Steffel J, Verhamme P, Potpara T, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-93. doi: 10.1093/eurheartj/ehy136
8. Lip G, Windecker S, Huber K, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J. 2014;35(45):3155-79. doi: 10.1093/eurheartj/ehu298
9. Valgimigli M, Bueno H, Byrne R, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2017;39(3):213-60. doi: 10.1093/eurheartj/ehx419
10. Neumann F, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10. 1093/eurheartj/ehy394
11. Hart R, Pearce L, Aguilar M. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med. 2007;146(12):857. doi: 10.7326/0003-4819-146-12-200706190-00007
12. 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. The Lancet. 2006;367(9526):1903-12. doi: 10.1016/s0140-6736(06)68845-4
13. Connolly S, Eikelboom J, Joyner C, et al. Apixaban in Patients with Atrial Fibrillation. New England J Medicine. 2011;364(9):806-17. doi: 10.1056/nejmoa 1007432
14. Bogacki P, Kabłak-Ziembicka A, Bryniarski K, et al. Triple anticoagulation therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention – real life assessment. Advances in Interventional Cardiology. 2016;4:303-13. doi: 10.5114/aic.2016.63629
15. Sørensen R, Hansen M, Abildstrom S, et al. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. The Lancet. 2009;374(9706):1967-74. doi: 10.1016/s0140-6736 (09)61751-7
16. Hansen M, Sørensen R, Clausen M, et al. Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in Patients With Atrial Fibrillation. Arch Intern Med. 2010;170(16). doi: 10.1001/archinternmed.20 10.271
17. Angiolillo D, Goodman S, Bhatt D, et al. Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention. Circulation. 2018;138(5):527-36. doi: 10. 1161/circulationaha.118.034722
18. Gibson C, Mehran R, Bode C, et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. New England J Medicine. 2016;375(25):2423-34. doi: 10.1056/nejmoa1611594
19. Cannon C, Bhatt D, Oldgren J, et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. New England J Medicine. 2017; 377(16):1513-24. doi: 10.1056/nejmoa1708454
20. Clemens A, Noack H, Ferreira J, Connolly S, Yusuf S, Lip G. Patient outcomes using the European label for dabigatran. Thromb Haemost. 2014;111(05):933-42. doi: 10.1160/th13-09-0734
21. Steinberg B, Shrader P, Pieper K, et al. Frequency and Outcomes of Reduced Dose Non–Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II). J Am Heart Assoc. 2018;7(4). doi: 10.1161/jaha.117.007633
22. Панченко Е.П. Профилактика тромбоэмболических осложнений у пациентов с фибрилляцией предсердий после стентирования коронарных артерий. Атеротромбоз. 2015;(1):2-15. Ссылка активна на 03.03.2019 [Panchenko EP. Profilaktika trombojembolicheskih oslozhnenij u pacientov s fibrilljaciej predserdij posle stentirovanija koronarnyh arterij. Aterotromboz. 2015;(1):2-15. Accessed March 3, 2019 (In Russ.)]. https://www.aterotromboz.ru/jour/article/view/2/2
23. Шахматова О.О., Панченко Е.П. Как снизить риск кровотечения при чрескожных коронарных вмешательствах у пациентов с фибрилляцией предсердий: уроки рандомизированных исследований и новые клинические рекомендации. Атеротромбоз. 2018;(1):93-106 [Shahmatova OO, Panchenko EP. Kak snizit' risk krovotechenija pri chreskozhnyh koronarnyh vmeshatel'stvah u pacientov s fibrilljaciej predserdij: uroki randomizirovannyh issledovanij i novye klinicheskie rekomendacii. Aterotromboz. 2018;(1):93-106 (In Russ.)]. doi: 10.21518/2307-1109-2018-1-93-106
24. Mehran R, Rao S, Bhatt D, et al. Standardized Bleeding Definitions for Cardiovascular Clinical Trials. Circulation. 2011;123(23):2736-47. doi: 10.1161/ circulationaha.110.009449
25. Charlson M, Pompei P, Ales K, MacKenzie C. A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8
26. Morisky D, Green L, Levine D. Concurrent and Predictive Validity of a Self-reported Measure of Medication Adherence. Med Care. 1986;24(1):67-74. doi: 10.1097/00005650-198601000-00007
27. McIntyre W, Conen D, Olshansky B, et al. Stroke-prevention strategies in North American patients with atrial fibrillation: The GLORIA-AF registry program. Clin Cardiol. 2018;41(6):744-51. doi:10.1002/clc.22936
28. Steinberg B, Gao H, Shrader P, et al. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017;194:132-40. doi: 10.1016/j.ahj.2017.08.011
29. Piran S, Schulman S, Panju M, Pai M. Oral anticoagulant dosing, administration, and storage: a cross-sectional survey of Canadian health care providers. J Thromb Thrombolysis. 2017;45(1):180-5. doi: 10.1007/s11239-017-1585-y
30. Larock A, Mullier F, Sennesael A, et al. Appropriateness of Prescribing Dabigatran Etexilate and Rivaroxaban in Patients With Nonvalvular Atrial Fibrillation. Annals of Pharmacotherapy. 2014;48(10):1258-68. doi: 10.1177/ 1060028014540868
31. Basaran O, Filiz Basaran N, Cekic E, et al. PRescriptiOn PattERns of Oral Anticoagulants in Nonvalvular Atrial Fibrillation (PROPER study). Clinical and Applied Thrombosis/Hemostasis. 2015;23(4):384-91. doi: 10.1177/1076029615 614395
32. Pattullo C, Barras M, Tai B, McKean M, Donovan P. New oral anticoagulants: appropriateness of prescribing in real-world setting. Intern Med J. 2016;46(7):812-8. doi: 10.1111/imj.13118
33. Belen E, Canbolat I, Bayyigit A, Helvaci A, Pusuroglu H, Kilickesmez K. A new gap in the novel anticoagulants’ era. Blood Coagulation & Fibrinolysis. 2015;26(7):793-7. doi: 10.1097/mbc.0000000000000349
34. Barra M, Fanikos J, Connors J, Sylvester K, Piazza G, Goldhaber S. Evaluation of Dose-Reduced Direct Oral Anticoagulant Therapy. Am J Med. 2016;129(11):1198-204. doi: 10.1016/j.amjmed.2016.05.041
35. Shrestha S, Baser O, Kwong W. Effect of Renal Function on Dosing of Non–Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation. Annals of Pharmacotherapy. 2017;52(2):147-53. doi: 10.1177/1060028017728295
36. Lavoie K, Turgeon M, Brais C, et al. Inappropriate dosing of direct oral anticoagulants in patients with atrial fibrillation. J Atr Fibrillation. 2016;9(4). doi: 10.4022/jafib.1478
37. Ruiz Ortiz M, Muñiz J, Raña Míguez P, et al. Inappropriate doses of direct oral anticoagulants in real-world clinical practice: prevalence and associated factors. A subanalysis of the FANTASIIA Registry. EP Europace. 2017;20(10):1577-83. doi: 10.1093/europace/eux316
38. Sato T, Aizawa Y, Fuse K, et al. The Comparison of Inappropriate-Low-Doses Use among 4 Direct Oral Anticoagulants in Patients with Atrial Fibrillation: From the Database of a Single-Center Registry. J Stroke and Cerebrovascular Diseases. 2018;27(11):3280-8. doi: 10.1016/j.jstrokecerebrovasdis.2018.07.028
39. Okumura Y, Yokoyama K, Matsumoto N, et al. Current use of direct oral anticoagulants for atrial fibrillation in Japan: Findings from the SAKURA AF Registry. J Arrhythm. 2017;33(4):289-96. doi: 10.1016/j.joa.2016.11.003
40. Yamashita Y, Uozumi R, Hamatani Y, et al. Current Status and Outcomes of Direct Oral Anticoagulant Use in Real-World Atrial Fibrillation Patients – Fushimi AF Registry. Circulation J. 2017;81(9):1278-85. doi: 10.1253/circj.cj-16-1337
41. Dewilde W, Oirbans T, Verheugt F, et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. The Lancet. 2013;381(9872):1107-15. doi: 10.1016/s0140-6736(12)62177-1
42. Abstract 10999: Outcomes Associated With Under-Dosing of Rivaroxaban for Management of Non-Valvular Atrial Fibrillation in Real World Clinical Setting From the XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients With Atrial Fibrillation). Circulation. 2018;138:A 10999Ahajournals.org. https://www.ahajournals.org/doi/abs/10.1161/circ.138. suppl_1.10999?af=R
43. Undas A. Fibrin clot properties and their modulation in thrombotic disorders. Thromb Haemost. 2014;112(07):32-42. doi: 10.1160/th14-01-0032
44. January C, Wann L, Alpert J, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):2246-80. doi: 10.1016/j.jacc.2014.03.021
45. Кропачева Е.С., Землянская О.А., Панченко Е.П., Добровольский А.Б., Кривошеева Е.Н. Безопасность длительной терапии варфарином: частота кровотечений и клинические предикторы их развития (результаты проспективного 15-летнего наблюдения). Атеротромбоз. 2017;(1):145-62 [Kropacheva ES, Zemljanskaja OA, Panchenko EP, Dobrovol'skij AB, Krivosheeva EN. Bezopasnost' dlitel'noj terapii varfarinom: chastota krovotechenij i klinicheskie prediktory ih razvitija (rezul'taty prospektivnogo 15-letnego nabljudenija). Aterotromboz. 2017;(1):145-62 (In Russ.)]. doi: 10.21518/ 2307-1109-2017-1-145-162
________________________________________________
2. Connolly S, Ezekowitz M, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2009;361(12):1139-51. doi: 10. 1056/nejmoa0905561
3. Granger C, Alexander J, McMurray J, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2011;365(11):981-92. doi:10. 1056/nejmoa1107039
4. Patel M, Mahaffey K, Garg J, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. New England J Medicine. 2011;365(10):883-91. doi: 10.1056/ nejmoa1009638
5. Giugliano R, Ruff C, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. New England J Medicine. 2013;369(22):2093-104. doi:10.1056/nejmoa1310907
6. [Diagnostika i lechenie fibrillyatsii predserdii. Rekomendatsii VNOK, RKO i ASSKh. Accessed March 3, 2019 (In Russ.)]. https://vnoa.ru/upload/ edition_ june2017/4_fp.pdf
7. Steffel J, Verhamme P, Potpara T, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-93. doi: 10.1093/eurheartj/ehy136
8. Lip G, Windecker S, Huber K, et al. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J. 2014;35(45):3155-79. doi: 10.1093/eurheartj/ehu298
9. Valgimigli M, Bueno H, Byrne R, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2017;39(3):213-60. doi: 10.1093/eurheartj/ehx419
10. Neumann F, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10. 1093/eurheartj/ehy394
11. Hart R, Pearce L, Aguilar M. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med. 2007;146(12):857. doi: 10.7326/0003-4819-146-12-200706190-00007
12. 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. The Lancet. 2006;367(9526):1903-12. doi: 10.1016/s0140-6736(06)68845-4
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Авторы
Е.Н. Кривошеева, Е.С. Кропачева, Е.П. Панченко, А.Н. Самко
ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России, Москва, Россия
National Medical Research Center for Cardiology, Moscow, Russia
ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России, Москва, Россия
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National Medical Research Center for Cardiology, Moscow, Russia
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