Preview

Rational Pharmacotherapy in Cardiology

Advanced search

Should a physician use the Beers criteria when prescribing direct oral anticoagulants to elderly patients?

https://doi.org/10.20996/1819-6446-2024-3089

EDN: UOXAZU

Abstract

The Beers Criteria are a tool for optimizing pharmacotherapy in elderly patients, containing information on potentially inappropriate drugs, which is only advisory in nature and is not mandatory for use in Russian Federation. In the updated version of the Beers Criteria from 2023, the expert opinion on rivaroxaban has changed — instead of "use with caution", as stated in the previous document from 2019, the experts now believe that "long-term treatment with rivaroxaban in non-valvular atrial fibrillation (AF) and venous thromboembolic complications (VTE) should be avoided in favor of safer alternative anticoagulants". This statement is based on moderate-quality evidence obtained from observational studies and network meta-analyses, which are significantly inferior to randomized controlled trials and have numerous limitations. The available evidence base for the use of rivaroxaban in elderly patients with AF and VTE and critical comments on the Beers criteria methodology, indicate the recommendations of the American Geriatrics Society experts regarding direct oral anticoagulants (DOAC) should be treated thoughtfully and carefully. When choosing a DOAC in elderly patients with AF or VTE, one should primarily focus on current clinical guidelines mandatory for use in Russian Federation, and on the data of studies that studied the efficacy and safety of specific DOACs in this category of patients. Rivaroxaban is a well-studied anticoagulant in elderly patients with AF and VTE, since its efficacy and safety have been established in RCTs and specially designed multicenter prospective observational studies with a fairly high quality of evidence. Based on this, rivaroxaban is a justified treatment option for elderly and senile patients with AF or VTE.

About the Authors

N. M. Vorobyeva
Russian Gerontological Scientific and Clinical Center, Pirogov Russian National Research Medical University
Russian Federation

Natalya M. Vorobyeva.

Moscow



I. P. Malaya
Russian Gerontological Scientific and Clinical Center, Pirogov Russian National Research Medical University
Russian Federation

Irina P. Malaya.

Moscow



V. D. Zakiev
Russian Gerontological Scientific and Clinical Center, Pirogov Russian National Research Medical University
Russian Federation

Vadim D. Zakiev.

Moscow



O. N. Tkacheva
Russian Gerontological Scientific and Clinical Center, Pirogov Russian National Research Medical University
Russian Federation

Olga N. Tkacheva.

Moscow



References

1. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-81. DOI:10.1111/jgs.18372.

2. By the 2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019;67(4):674-94. DOI:10.1111/jgs.15767.

3. Martsevich SYu, Navasardyan AR, Lobastov KV, et al. Systematic review and meta-analysis: a critical examination of the methodology. Rational Pharmacothe­rapy in Cardiology. 2023;19(4):382-97 (In Russ.) DOI:10.20996/1819-6446-2023-2923.

4. Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. DOI:10.1056/NEJMoa0905561.

5. Patel MR, Mahaffey KW, Garg J, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91. DOI:10.1056/NEJMoa1009638.

6. Granger CB, Alexander JH, McMurray JJ, et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-92. DOI:10.1056/NEJMoa1107039.

7. Lopes RD, Al-Khatib SM, Wallentin L, et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomized controlled trial. Lancet, 2012;380(9855):1749-58. DOI:10.1016/S0140-6736(12)60986-6.

8. Piccini JP, Garg J, Patel MR, et al; ROCKET AF Investigators. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J. 2014;35(28):1873-80. DOI:10.1093/eurheartj/ehu083.

9. Martsevich SYu, Navasardian AR, Zakharova NA, Lukianov ММ. New oral anticoagulants: is that plausible to implement the data from international trials to Russian population? Cardiovascular Therapy and Prevention. 2015;14(5):48-52 (In Russ.) DOI:10.15829/1728-8800-2015-5-48-52.

10. Boytsov SA, Luk’yanov MM, Yakushin SS, 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. (In Russ.) DOI:10.15829/1728-8800-2014-6-3-8.

11. Halperin JL, Hankey GJ, Wojdyla DM, et al; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-46. DOI:10.1161/CIRCULATIONAHA.113.005008.

12. Camm AJ, Amarenco P, Haas S, et al; XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016;37(14):1145-53. DOI:10.1093/eurheartj/ehv466.

13. Kirchhof P, Radaideh G, Kim YH, et al; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018;72(2):141-53. doi:10.1016/j.jacc.2018.04.058.

14. Steffel J, Collins R, Antz M, et al; External reviewers. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021;23(10):1612-76. DOI:10.1093/europace/euab065.

15. Hanon O, Chaussade E, David JP, et al; SAFIR cohort: One-year prospective follow-up of very old and frail patients treated with direct oral anticoagulant, rivaroxaban. Arch Cardiovasc Dis Suppl. 2020;12(1):115. DOI:10.1016/j.acvdsp.2019.09.250.

16. Hanon O, Vidal JS, Pisica-Donose G, et al; SAFIR study group. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation. Heart. 2021;107(17):1376-82. DOI:10.1136/heartjnl-2020-317923.

17. Schulman S, Kearon C, Kakkar AK, et al; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):2342-52. DOI:10.1056/NEJMoa0906598.

18. Schulman S, Kakkar AK, Goldhaber SZ, et al; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-72. DOI:10.1161/CIRCULATIONAHA.113.004450.

19. EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-510. DOI:10.1056/NEJMoa1007903.

20. EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, et al. Oral rivaro­xaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-97. DOI:10.1056/NEJMoa1113572.

21. Agnelli G, Buller HR, Cohen A, et al; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808. DOI:10.1056/NEJMoa1302507.

22. Prins MH, Lensing AW, Bauersachs R, et al; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21. DOI:10.1186/1477-9560-11-21.

23. Ageno W, Mantovani LG, Haas S, et al. Safety and effectiveness of oral rivaroxa­ban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016;3(1):e12-21. DOI:10.1016/S2352-3026(15)00257-4.

24. Kreutz R, Mantovani LG, Haas S, et al. XALIA-LEA: An observational study of venous thromboembolism treatment with rivaroxaban and standard anticoagulation in the Asia-Pacific, Eastern Europe, the Middle East, Africa and Latin America. Thromb Res. 2019;176:125-32. DOI:10.1016/j.thromres.2019.02.010.

25. Haas S, Mantovani LG, Kreutz R, et al. Anticoagulant treatment for venous thromboembolism: A pooled analysis and additional results of the XALIA and XALIA-LEA noninterventional studies. Res Pract Thromb Haemost. 2021;5(3):426-38. DOI:10.1002/rth2.12489.

26. O’Mahony D, Cherubini A, Guiteras AR, et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023;14(4):625-32. DOI:10.1007/s41999-023-00812-y.

27. Runikhina NK, Cherniaeva MS, Malaya IP, et al. Enhanced STOPP/START Cri­teria: A Tool for Managing Polypharmacy in Older Population. Russian Journal of Geriatric Medicine. 2023;16(4):273-88. (In Russ.) DOI:10.37586/2686-8636-4-2023-273-288.

28. Pazan F, Weiss C, Wehling M; FORTA Expert Panel Members. The EURO-FORTA (Fit fOR The Aged) List Version 2: Consensus Validation of a Clinical Tool for Impro­ved Pharmacotherapy in Older Adults. Drugs Aging. 2023;40(5):417-26. DOI:10.1007/s40266-023-01024-6.

29. Dobesh PP, Trujillo TC. Comment on the 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2024;72(2):631-3. DOI:10.1111/jgs.18721.

30. Burnett AE, Barnes GD, Allen AL, et al; Anticoagulation Forum Board of Directors. Comment on: 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(12):3951-53. DOI:10.1111/jgs.18579.

31. Creixell M, Harxhi A. The importance of assessing the safe and effective use of oral anticoagulants in older adults. J Am Geriatr Soc. 2023;71(12):3954-56. DOI:10.1111/jgs.18587.


Supplementary files

Review

For citations:


Vorobyeva N.M., Malaya I.P., Zakiev V.D., Tkacheva O.N. Should a physician use the Beers criteria when prescribing direct oral anticoagulants to elderly patients? Rational Pharmacotherapy in Cardiology. 2024;20(4):460-467. (In Russ.) https://doi.org/10.20996/1819-6446-2024-3089. EDN: UOXAZU

Views: 285


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)