The Nephrological Aspects of the Use of Rivaroxaban and Other Direct Peroral Anticoagulants in Non-Valvular Atrial Fibrillation
https://doi.org/10.18087/cardio.2019.6.n516
Abstract
Chronic kidney disease (CKD) is a powerful cardiovascular risk factor, its presence is accompanied by an increased risk of hospitalization for exacerbation of chronic heart failure (CHF), adverse outcomes in myocardial infarction, and cardiovascular mortality. Among the adverse events, an increased risk of atrial fibrillation (AF) should be noted. This article contains discussion of current approaches to the treatment of AF in patients with different stages of CKD, data on benefits of certain direct oral anticoagulants, as well as comparative characteristics of therapy with direct oral anticoagulants and warfarin. Pharmacokinetics and pharmacodynamics of direct oral anticoagulants, which determine the features of therapy in CKD, are also considered.
About the Author
M. M. Batiushin
Federal state budgetary educational institution of higher education "Rostov state medical University" of the Ministry of health of the Russian Federation
Russian Federation
Russian Federation
Mikhail M. Batiushin – MD, professor
Rostov-on-Don
References
1. Go AS, Yang J, Ackerson LM, Lepper K, Robbins S, Massie BM et al. Hemoglobin Level, Chronic Kidney Disease, and the Risks of Death and Hospitalization in Adults With Chronic Heart Failure: The Anemia in Chronic Heart Failure: Outcomes and Resource Utilization (ANCHOR) Study. Circulation. 2006;113(23):2713–23. DOI: 10.1161/CIRCULATIONAHA.105.577577
2. Anavekar NS, McMurray JJV, Velazquez EJ, Solomon SD, Kober L, Rouleau J-L et al. Relation between Renal Dysfunction and Cardiovascular Outcomes after Myocardial Infarction. New England Journal of Medicine. 2004;351(13):1285–95. DOI: 10.1056/NEJMoa041365
3. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu C. Chronic Kidney Disease and the Risks of Death, Cardiovascular Events, and Hospitalization. New England Journal of Medicine. 2004;351(13):1296–305. DOI: 10.1056/NEJMoa041031
4. Alonso A, Lopez FL, Matsushita K, Loehr LR, Agarwal SK, Chen LY et al. Chronic Kidney Disease Is Associated With the Incidence of Atrial Fibrillation: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2011;123(25):2946–53. DOI: 10.1161/CIRCULATIONAHA.111.020982
5. Nelson SE, Shroff GR, Li S, Herzog CA. Impact of Chronic Kidney Disease on Risk of Incident Atrial Fibrillation and Subsequent Survival in Medicare Patients. Journal of the American Heart Association. 2012;1(4):e002097. DOI: 10.1161/JAHA.112.002097
6. Soliman EZ, Safford MM, Muntner P, Khodneva Y, Dawood FZ, Zakai NA et al. Atrial fibrillation and the risk of myocardial infarction. JAMA internal medicine. 2014;174(1):107–14. DOI: 10.1001/jamainternmed.2013.11912
7. Bansal N, Fan D, Hsu C, Ordonez JD, Go AS. Incident Atrial Fibrillation and Risk of Death in Adults With Chronic Kidney Disease. Journal of the American Heart Association. 2014;3(5):e001303. DOI: 10.1161/JAHA.114.001303
8. Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB et al. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney International. 2010;77(12):1098–106. DOI: 10.1038/ki.2009.477
9. Jain N, Reilly RF. Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease. Clinical Journal of the American Society of Nephrology. 2019;14(2):278–87. DOI: 10.2215/CJN.02170218
10. Boytsov S. A., Luk’yanov M. M., Yakushin S. S., Martsevich S. Yu., Vorobyov A. N., Zagrebelny A. V. et al. Cardiovascular diseases registry (RECVAZA): diagnostics, concomitant cardiovascular pathology, comorbidities and treatment in the real outpatient-polyclinic practice. Cardiovascular Therapy and Prevention. 2014;13(6):44–50. [Russian]. DOI: 10.15829/1728-8800-2014-6-44-50
11. Shroff GR, Stoecker R, Hart A. Non-Vitamin K-Dependent Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Patients With CKD: Pragmatic Considerations for the Clinician. American Journal of Kidney Diseases. 2018;72(5):717–27. DOI: 10.1053/j.ajkd.2018.02.360
12. Fox KAA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. European Heart Journal. 2011;32(19):2387–94. DOI: 10.1093/eurheartj/ehr342
13. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. New England Journal of Medicine. 2011;365(10):883–91. DOI: 10.1056/NEJMoa1009638
14. Hori M, Fukaya T, Kleine E, Reilly PA, Ezekowitz MD, Connolly SJ et al. Efficacy and Safety of Dabigatran Etexilate vs. Warfarin in Asian RE-LY Patients According to Baseline Renal Function or CHADS2 Score. Circulation Journal. 2015;79(10):2138–47. DOI: 10.1253/circj.CJ-15-0594
15. Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral antico- agulants in patients with atrial fibrillation. European Heart Journal. 2018;39(16):1330–93. DOI: 10.1093/eurheartj/ehy136
16. Del-Carpio Munoz F, Gharacholou SM, Munger TM, Friedman PA, Asirvatham SJ, Packer DL et al. Meta-analysis of renal function on the safety and efficacy of novel oral anticoagulants for atrial fibrillation. The American Journal of Cardiology. 2016;117(1):69– 75. DOI: 10.1016/j.amjcard.2015.09.046
17. Clinical guidelines “Atrial Fibrillation” FGBU A.N. Bakoulev NNPCCS MZ RF (2017). 2017; [Russian] https://racvs.ru/clinic/files/2017/Atrial-Fibrillation.pdf
18. Revishvili A. Sh., Shlyakhto E. V., Sulimov V. A., Rzaev F. G., Gorev M. V., Nardaya Sh. G. et al. Recommendations RKO, VNOA and ASSH “Diagnosis and treatment of atrial fibrillation” 2017. [Russian] http://webmed.irkutsk.ru/doc/pdf/af.pdf
19. State register of medicinal products: rivaroxaban, apixaban, dabigatran. [Russian] https://grls.rosminzdrav.ru/Default.aspx
20. Mavrakanas TA, Samer CF, Nessim SJ, Frisch G, Lipman ML. Apixaban Pharmacokinetics at Steady State in Hemodialysis Patients. Journal of the American Society of Nephrology. 2017;28(7):2241–8. DOI: 10.1681/ASN.2016090980
21. Koretsune Y, Yamashita T, Kimura T, Fukuzawa M, Abe K, Yasaka M. Short-Term Safety and Plasma Concentrations of Edoxaban in Japanese Patients With Non-Valvular Atrial Fibrillation and Severe Renal Impairment. Circulation Journal. 2015;79(7):1486– 95. DOI: 10.1253/circj.CJ-14-0942
22. De Vriese AS, Caluwé R, Bailleul E, De Bacquer D, Borrey D, Van Vlem B et al. Dose-Finding Study of Rivaroxaban in Hemodialysis Patients. American Journal of Kidney Diseases. 2015;66(1):91–8. DOI: 10.1053/j.ajkd.2015.01.022
23. Reinecke H, Engelbertz C, Schäbitz W-R. Preventing Stroke in Patients With Chronic Kidney Disease and Atrial Fibrillation: Benefit and Risks of Old and New Oral Anticoagulants. Stroke. 2013;44(10):2935–41. DOI: 10.1161/STROKEAHA.113.001701
24. Herzog CA, Asinger RW, Berger AK, Charytan DM, Díez J, Hart RG et al. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney International. 2011;80(6):572–86. DOI: 10.1038/ki.2011.223
25. Reinecke H, Brand E, Mesters R, Schäbitz W-R, Fisher M, Pavenstädt H et al. Dilemmas in the Management of Atrial Fibrillation in Chronic Kidney Disease. Journal of the American Society of Nephrology. 2009;20(4):705–11. DOI: 10.1681/ASN.2007111207
26. Limdi NA, Limdi MA, Cavallari L, Anderson AM, Crowley MR, Baird MF et al. Warfarin Dosing in Patients With Impaired Kidney Function. American Journal of Kidney Diseases. 2010;56(5):823– 31. DOI: 10.1053/j.ajkd.2010.05.023
27. Limdi NA, Nolin TD, Booth SL, Centi A, Marques MB, Crowley MR et al. Influence of Kidney Function on Risk of Supratherapeutic International Normalized Ratio–Related Hemorrhage in Warfarin Users: A Prospective Cohort Study. American Journal of Kidney Diseases. 2015;65(5):701–9. DOI: 10.1053/j.ajkd.2014.11.004
28. Quinn RR, Naimark DMJ, Oliver MJ, Bayoumi AM. Should Hemodialysis Patients With Atrial Fibrillation Undergo Systemic Anticoagulation? A Cost-Utility Analysis. American Journal of Kidney Diseases. 2007;50(3):421–32. DOI: 10.1053/j.ajkd.2007.05.019
29. Yalamanchili V, Reilly RF. Does the risk exceed the benefit for anticoagulation in end-stage renal disease patients with nonrheumatic atrial fibrillation? Seminars in Dialysis. 2011;24(4):387–8. DOI: 10.1111/j.1525-139X.2011.00885.x
30. Chan KE, Lazarus JM, Thadhani R, Hakim RM. Anticoagulant and Antiplatelet Usage Associates with Mortality among Hemodialysis Patients. Journal of the American Society of Nephrology. 2009;20(4):872–81. DOI: 10.1681/ASN.2008080824
31. Hart RG, Eikelboom JW, Brimble KS, McMurtry MS, Ingram AJ. Stroke Prevention in Atrial Fibrillation Patients With Chronic Kidney Disease. Canadian Journal of Cardiology. 2013;29(7):S71– 8. DOI: 10.1016/j.cjca.2013.04.005
32. Eiser AR. Warfarin, Calciphylaxis, Atrial Fibrillation, and Patients on Dialysis: Outlier Subsets and Practice Guidelines. The American Journal of Medicine. 2014;127(4):253–4. DOI: 10.1016/j.amjmed.2013.08.033
33. Wheeler DS, Giugliano RP, Rangaswami J. Anticoagulation- related nephropathy. Journal of Thrombosis and Haemostasis. 2016;14(3):461–7. DOI: 10.1111/jth.13229
34. Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S et al. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study. Circulation Journal: Official Journal of the Japanese Circulation Society. 2012;76(9):2104–11. PMID: 22664783
35. Dias C, Moore KT, Murphy J, Ariyawansa J, Smith W, Mills RM et al. Pharmacokinetics, Pharmacodynamics, and Safety of Single- Dose Rivaroxaban in Chronic Hemodialysis. American Journal of Nephrology. 2016;43(4):229–36. DOI: 10.1159/000445328
36. Kubitza D, Becka M, Mueck W, Halabi A, Maatouk H, Klause N et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor: Rivaroxaban pharmacokinetics, pharmacodynamics and safety in renal impairment. British Journal of Clinical Pharmacology. 2010;70(5):703–12. DOI: 10.1111/j.1365-2125.2010.03753.x
37. Stangier J, Rathgen K, Stähle H, Mazur D. Influence of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate: An Open-Label, Parallel-Group, Single-Centre Study. Clinical Pharmacokinetics. 2010;49(4):259– 68. DOI: 10.2165/11318170-000000000-00000
38. Chang M, Yu Z, Shenker A, Wang J, Pursley J, Byon W et al. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban. The Journal of Clinical Pharmacology. 2016;56(5):637–45. DOI: 10.1002/jcph.633
39. Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D et al. Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis. The Journal of Clinical Pharmacology. 2016;56(5):628–36. DOI: 10.1002/jcph.628
40. Bassand J-P, Accetta G, Al Mahmeed W, Corbalan R, Eikelboom J, Fitzmaurice DA et al. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLOS ONE. 2018;13(1):e0191592. DOI: 10.1371/journal.pone.0191592
41. Martinez BK, Sood NA, Bunz TJ, Coleman CI. Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin in Frail Patients With Nonvalvular Atrial Fibrillation. Journal of the American Heart Association. 2018;7(8):e008643. DOI: 10.1161/JAHA.118.008643
42. Segal JB, Chang H-Y, Du Y, Walston JD, Carlson MC, Varadhan R. Developmentofa Claims-based Frailty Indicator Anchoredtoa Wellestablished Frailty Phenotype: Medical Care. 2017;55(7):716–22. DOI: 10.1097/MLR.0000000000000729
43. Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ et al. Factors associated with non–vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). American Heart Journal. 2017;189:40–7. DOI: 10.1016/j.ahj.2017.03.024
44. Yao X, Tangri N, Gersh BJ, Sangaralingham LR, Shah ND, Nath KA et al. Renal Outcomes in Anticoagulated Patients With Atrial Fibrillation. Journal of the American College of Cardiology. 2017;70(21):2621–32. DOI: 10.1016/j.jacc.2017.09.1087
45. Hijazi Z, Hohnloser SH, Andersson U, Alexander JH, Hanna M, Keltai M et al. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiology. 2016;1(4):451–60. DOI: 10.1001/jamacardio.2016.1170
46. Böhm M, Ezekowitz MD, Connolly SJ, Eikelboom JW, Hohnloser SH, Reilly PA et al. Changes in renal function in patients withatrialfibrillation. Journalofthe American Collegeof Cardiology. 2015;65(23):2481–93. DOI: 10.1016/j.jacc.2015.03.577
47. Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC et al. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With WarfarinClinical Perspective: Insights From ROCKET AF. Circulation. 2016;134(1):37–47. DOI: 10.1161/CIRCULATIONAHA.116.021890
48. Weir MR, Berger JS, Ashton V, Laliberté F, Brown K, Lefebvre P et al. Impact of renal function on ischemic stroke and major bleeding rates in nonvalvular atrial fibrillation patients treated with warfa- rin or rivaroxaban: a retrospective cohort study using real-world evi- dence. Current Medical Research and Opinion. 2017;33(10):1891– 900. DOI: 10.1080/03007995.2017.1339674
49. Numao Y, Suzuki S, Arita T, Yagi N, Otsuka T, Sagara K et al. Predictors of International Normalized Ratio Variability in Patients With Atrial Fibrillation Under Warfarin Therapy. Circulation Journal. 2018;82(1):39–45. DOI: 10.1253/circj.CJ-16-1217
50. Fitzmaurice DA, Accetta G, Haas S, Kayani G, Lucas Luciardi H, Misselwitz F et al. Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treat- ed with vitamin K antagonists. British Journal of Haematology. 2016;174(4):610–23. DOI: 10.1111/bjh.14084
51. Pokorney SD, Simon DN, Thomas L, Fonarow GC, Kowey PR, Chang P et al. Patients’ time in therapeutic range on warfarin among US patients with atrial fibrillation: Results from ORBIT-AF registry. American Heart Journal. 2015;170(1):141-148.e1. DOI: 10.1016/j.ahj.2015.03.017
52. Rose AJ, Delate T, Ozonoff A, Witt DM. Comparison of the Abilities of Summary Measures of International Normalized Ratio Control to Predict Clinically Relevant Bleeding. Circulation: Cardiovascular Quality and Outcomes. 2015;8(5):524–31. DOI: 10.1161/CIRCOUTCOMES.115.001768
53. Vanerio G. International Normalized Ratio Variability: A Measure of Anticoagulation Quality or a Powerful Mortality Predictor. Journalof Strokeand Cerebrovascular Diseases. 2015;24(10):2223–8. DOI: 10.1016/j.jstrokecerebrovasdis.2015.05.017
54. Björck F, Renlund H, Lip GYH, Wester P, Svensson PJ, Själander A. Outcomes in a Warfarin-Treated Population With Atrial Fibrillation. JAMA Cardiology. 2016;1(2):172. DOI: 10.1001/jamacardio.2016.0199
55. Gallagher AM, Setakis E, Plumb JM, Clemens A, van Staa T-P. Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients: Thrombosis and Haemostasis. 2011;106(5):968–77. DOI: 10.1160/TH11-05-0353
56. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016;37(38):2893–962. DOI: 10.1093/eurheartj/ehw210
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For citations:
Batiushin M.M. The Nephrological Aspects of the Use of Rivaroxaban and Other Direct Peroral Anticoagulants in Non-Valvular Atrial Fibrillation. Kardiologiia. 2019;59(6):60-69. (In Russ.) https://doi.org/10.18087/cardio.2019.6.n516
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