Current guidelines and prospects for using novel oral anticoagulants for nonvalvular atrial fibrillation
https://doi.org/10.14412/2074-2711-2014-4-19-25
Abstract
The capabilities of antithrombotic therapy to prevent systemic thromboembolic events in nonvalvular atrial fibrillation (AF) are substantially extended after clinically introducing novel oral anticoagulants (NOACs), such as dabigatran, rivaroxaban, and apixaban. World clinical experience with NOACs in AF has confirmed their efficacy and safety in both primary and secondary stroke prevention. At the same time, apixaban additionally reduces the risk of fatal outcomes and it is the safest among the NOACs against hemorrhagic events. The low risks of intracranial hemorrhage typical of NOACs should be taken into account when choosing oral anticoagulant therapy after hemorrhagic stroke in patients at
high risk for thromboembolic events due to AF. Whether NOACs may be used in acute myocardial infarction and during coronary stenting in the presence of nonvalvular AF, left ventricular thromboses, and cardiomyopathies is considered. In real clinical practice, nonvalvular AF may be accompanied by different cardiovascular diseases, by creating the situations where there are no specific guidelines for the use of NOACs. The results of comparing the clinical efficiency of different antithrombotic therapy regimens, the subanalysis of randomized trials, and experts’ opinions may assist a physician to substantiate their decisions. Thus, just a few NOACs that are similar and/or superior to warfarin in efficacy and safety have emerged to date. There are grounds to believe that many physicians will prefer direct anticoagulants to warfarin not only because of their proven efficacy, but also the rapid onset of their anticoagulant effect, neither interaction with a number of foods or drugs, and above all, nor need for regular laboratory blood testing. World post-marketing
surveillance and new clinical tests will be helpful in better estimating the benefits and risks of treatment with NOACs and in expanding indications for their use, which will considerably enhance the possibilities of preventing thromboembolic events in cardiac pathology in the period ahead.
About the Author
A. V. Fonyakin
Neurology Research Center, Moscow, Russia
80, Volokolamskoe Shosse, Moscow 125367
Russian Federation
Russian Federation
References
1. Go AS, Hylek EM, Philips KA, 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;285:2370–5. DOI: http://dx.doi.org/10.1001/jama.285.18.2370.
2. Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009;104:1534–9. DOI: http://dx.doi.org/10.1016/j.amjcard. 2009.07.022.
3. Wolf PA, Abbot RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly: the Framingham Study. Arch Intern Med. 1987;147:1561–4. DOI: http://dx.doi.org/10.1001/archinte. 1987.00370090041008.
4. Диагностика и лечение фибрилляции предсердий. Рекомендации РКО, ВНОА и АССХ. Москва; 2012. 112 c. [Diagnostika i lechenie fibrillyatsii predserdii. Rekomendatsii RKO, VNOA i ASSKh [Diagnostics and treatment of fibrillation of auricles. Recommendations of PKO, BHOA and ACCX. Moscow; 2012. 112 p]. Moscow; 2012. 112 p.]
5. January CT, Wann LS, Alpert JS, et al. Guideline for the Management of Patients with Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;63. Available from: www.cardiosource. org. DOI: 10.1016/j.jacc.2014.03.021.
6. Суслина ЗА, Фонякин АВ, Петрова ЕА и др. Значение холтеровского мониторирования ЭКГ у больных в остром периоде ишемического инсульта. Терапевтический архив. 1997;69(4):24–6. [Suslina ZA, Fonyakin AV, Petrova EA, et al. Value of holter monitoring of an electrocardiogram at patients in the sharp period of an ischemic stroke. Terapevticheskii arkhiv. 1997;69(4):24–6. (In Russ.)]
7. Фонякин АВ, Гераскина ЛА, Суслина ЗА. Сравнительная оценка постоянной и пароксизмальной фибрилляции предсердий в патогенезе кардиоцеребральной эмболии. Кардиология. 2002;42(7):4–6. [Fonyakin AV, Geraskina LA, Suslina ZA. Comparative assessment of continuous and paroxizmal fibrillation of auricles in pathogenesis of a cardiocerebral embolism. Kardiologiya. 2002;42(7):4–6. (In Russ.)]
8. Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864–70. DOI: http://dx.doi.org/10.1001/jama.285.22.2864.
9. Lip GY, 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;137:263–72. DOI: http://dx.doi.org/10.1378/chest.09-1584.
10. Camm AJ, Lip GY, De Caterina R. 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. Eur Heart Journal. 2012; 33(21):2719–47. DOI: 10.1093/eurheartj/ehs253.Epub 2012 Aug 24.
11. You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e531S– 75S. DOI: 10.1378/chest.11-2304.
12. Furie KL, Goldstein LB, Albers GW, et al. Oral antithrombotic agents for the prevention of stroke in nonvalvular atrial fibrillation: a science advisory for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2012;43:3442–53. DOI: http://dx.doi.org/10.1161/STR. 0b013e318266722a.
13. Kernan WN, Ovbiagele B, Black HR, et al. 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. 2014;45:2160–236. DOI: http://dx.doi.org/10.1161/STR. 0000000000000024.
14. 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. DOI: http://dx.doi.org/10.1001/archinte.160.7.967.
15. Baker W, Cios D, Sander S, Coleman CI. Meta-analysis to assess the quality of warfarincontrol in atrial fibrillation patients in the United States. J Manag Care Pharm. 2009;15(3):244–52.
16. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51. DOI: http://dx.doi.org/10.1056/NEJMoa0905561.
17. 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(3):340–47.e1. DOI: 10.1016/j.ahj.2009.11.025.
18. Patel MR, Mahaffey KW, Gard J, et al. Rivaroxaban vs Warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91. DOI: http://dx.doi.org/10.1056/ NEJMoa1009638.
19. Granger ChB, Alexander JH, McMurray JJ. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92. DOI: http://dx.doi.org/10.1056/ NEJMoa1107039.
20. Garcia D, Libby E, Crowther MA. The new oral anticoagulants. Blood. 2010;115:15–20. DOI: http://dx.doi.org/10.1182/blood-2009-09-241851.
21. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364:806–17. DOI: http://dx.doi.org/10.1056/NEJMoa1007432.
22. Cucchiara BL, Kasner SE. Apixaban in atrial fibrillation: from bleeding cows to 21st century medicinal chemistry. Stroke. 2011;42:2376–8. DOI: http://dx.doi.org/10.1161/ STROKHA.111.619338.
23. Heidbuchel H, Verhamme P, Alings M, et al. European heart rhythm association practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2013;15(5):625–51. DOI: 10.1093/europace/eut083.
24. Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence-based guideline update: Prevention of stroke in nonvalvular atrial fibrillation. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014;82:716–24. DOI: http://dx.doi.org/10.1212/WNL. 0000000000000145.
25. Stroke Risk in Atrial Fibrillation Working Group. Independent predictors of stroke in atrial fibrillation: a systematic review. Neurology. 2007;69(6):546–54. DOI: http://dx.doi.org/10.1212/01.wnl. 0000267275.68538.8d.
26. Palareti G, Cosmi B. Bleeding with anticoagulation therapy – who is at risk, and how best to identify such patients. Thromb Haemost. 2009;102(2):268–78. DOI: 10.1160/TH08-11-0730.
27. European Atrial Fibrillation Trial (EAFT) Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet. 1993;342(8882):1255–62.
28. Morocutti C, Amabile G, Fattanpposta F, et al.; SIFA (Studio Italiano Fibrillazione Atrial) Investigators. Indobufen versus warfarin in the secondary prevention of major vascular events in nonrheumatic atrial fibrillation. Stroke. 1997;28(5):1015–21. DOI: http://dx.doi.org/10.1161/01.STR.28.5.1015.
29. Hart RG, Pearce LA, Aguilar MI. Metaanalysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857–67. DOI: http://dx.doi.org/10.7326/0003-4819-146-12-200706190-00007.
30. 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 RE-LY trial. Lancet Neurol. 2010;9(12):1157–63. DOI: 10.1016/S1474- 4422(10)70274-X. Epub 2010 Nov 6.
31. Hankey GJ, Patel MR, Stevens SR, et al. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012;11(4):315–22. DOI: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.
32. Jauch EC, Saver JL, Adams HP, et al. Guidelines for the early management of patients with acute ischemic stroke. Stroke. 2013;44:870–947. DOI: http://dx.doi.org/10.1161/STR. 0b013e318284056a.
33. Broderick JP, Adams HP Jr, Barsan W, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke. 1999;30(4):905–15. DOI: http://dx.doi.org/10.1161/01.STR.30.4.905.
34. Flaherty ML, Tao H, Haverbusch M, et al. Warfarin use leads to larger intracerebralhematomas. Neurology. 2008;71:1084–9. DOI: http://dx.doi.org/10.1212/01.wnl. 0000326895.58992.27.
35. Leissinger CA, Blatt PM, Hoots WK, Ewenstein B. Role of prothrombin complex concentrates in reversing warfarin anticoagulation: a review of the literature. Am J Hematol. 2008;83(2):137–43. DOI: http://dx.doi.org/10.1002/ajh.21046.
36. Butler AC, Tait RC. Restarting anticoagulation in prosthetic heart valve patients after intracranial haemorrhage: a 2-year follow-up. Br J Haematol. 1998;103:1064–6. DOI: http://dx.doi.org/10.1046/j.1365-2141. 1998.01078.x.
37. Phan TG, Koh M, Wijdicks EF. Safety of discontinuation of anticoagulation in patients with intracranial hemorrhage at high thromboembolic risk. Arch Neurol. 2000;57:1710–3. DOI: http://dx.doi.org/10.1001/archneur.57.12.1710.
38. Hanger HC, Wilkinson TJ, Fayez-Iskander N, Sainsbury R. The risk of recurrent stroke after intracerebral haemorrhage. J Neurol Neurosurg Psychiatry. 2007;78:836–40. DOI: http://dx.doi.org/10.1136/jnnp.2006.106500.
39. Campbell NR, Hull RD, Brant R, et al. Aging and heparin-related bleeding. Arch Intern Med. 1996;156:857–60. DOI: http://dx.doi.org/10.1001/archinte. 1996.00440080047006.
40. Fan YH, Zhang L, Lam WW, et al. Cerebral microbleeds as a risk factor for subsequent intracerebral hemorrhages among patients with acute ischemic stroke. Stroke. 2003;34:2459–62. DOI: http://dx.doi.org/10.1161/01.STR.0000090841.90286.81.
41. Smith EE, Rosand J, Knudsen KA, et al. Leukoaraiosis is associated with warfarin-related hemorrhage following ischemic stroke. Neurology. 2002;59:193–7. DOI: http://dx.doi.org/10.1212/WNL.59.2.193.
42. Vazquez E, Sanchez-Perales C, Garcia-Cortes MJ, et al. Ought dialysis patients with atrial fibrillation be treated with oral anticoagulants? Int J Cardiol. 2003;87:135–9. DOI: http://dx.doi.org/10.1016/S0167-5273 (02)00317-0.
43. Bertram M, Bonsanto M, Hacke W, Schwab S. Managing the therapeutic dilemma: patients with spontaneous intracerebral hemorrhage and urgent need for anticoagulation. J Neurol. 2000;247:209–14. DOI: http://dx.doi.org/10.1007/s004150050565.
44. Фонякин АВ, Гераскина ЛА. Профилактика ишемического инсульта. Рекомендации по антитромботической терапии. Под ред. З.А. Суслиной. Москва: ИМА-ПРЕСС; 2014. 72 с. [Fonyakin AV, Geraskina LA. Profilaktika ishemicheskogo insul'ta. Rekomendatsii po antitromboticheskoi terapii [Prevention of an ischemic stroke. Recommendations about antitrombotic therapy]. Suslina ZA, editor. Moscow: IMA-PRESS; 2014. 72 p.]
45. Фонякин АВ, Гераскина ЛА. Ривароксабан во вторичной профилактике кардиоэмболического инсульта: стандарты и нестандартные ситуации. Неврология, нейропсихиатрия, психосоматика. 2014;(1):48–53. [Fonyakin AV, Geraskina LA. Rivaroxaban in secondary prevention of cardioembolic stroke: standards and abnormal situations. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2014;(1):48–53. (In Russ.)]. DOI: http://dx.doi.org/10.14412/2074-2711-
46. -1-48-53.
47. Фонякин АВ. Дабигатрана этексилат при неклапанной фибрилляции предсердий в реальной практике и перспективы его применения для профилактики инсульта. Неврология, нейропсихиатрия, психосоматика. 2014;(2):44–50. [Fonyakin AV. Dabigatran etexilate for nonvalvular atrial fibrillation in real practice and promises for its use to prevent stroke. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2014;(2):44–50. (In Russs.)]. DOI: http://dx.doi.org/10.14412/2074-2711-2014-2-44-50.
Review
For citations:
Fonyakin A.V. Current guidelines and prospects for using novel oral anticoagulants for nonvalvular atrial fibrillation. Neurology, Neuropsychiatry, Psychosomatics. 2014;6(4):19-25. (In Russ.) https://doi.org/10.14412/2074-2711-2014-4-19-25
Views: 785
Email this article 