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Studies of Anticoagulant Therapy in Frail Elderly Patients: Problems of Terminology and Methodology

Abstract

A recently published article (Rational Pharmacotherapy in Cardiology 2018;6:908-16) on the problems of anticoagulant therapy in patients with frailty syndrome contains two statements which highlight rivaroxaban among other non-vitamin K antagonist oral anticoagulants (NOAC): 1) none of the randomized controlled trials (RCTs) with NOAC (except for two RCTs with rivaroxaban – EINSTEIN-DVT and EINSTEIN-PE) contained data on the participation of frail patients; 2) one of the studies of real clinical practice showed that only therapy with rivaroxaban (out of three NOAC) in comparison to warfarin reduced the risk of stroke / systemic embolism and ischemic stroke in frail elderly patients with atrial fibrillation after 2 years of observation. The paper presents a critical analysis of these statements showing that the first statement is based on the incorrect use of the collective term “fragility” as a synonym for the term “frailty”, whereas the second statement is based on the results of a study that has a number of serious methodological limitations.

About the Authors

Sergey N. Bel'diev
Tver State Medical University
Russian Federation
Chair of Therapy and Cardiology, Associate Professor


Irina V. Medvedeva
Tver State Medical University
Russian Federation
Chair of Therapy and Cardiology, Associate Professor


Dmitry Yu. Platonov
Tver State Medical University
Russian Federation
Chair of Therapy and Cardiology, Head


Galina Yu. Trufanova
Tver State Medical University
Russian Federation
Chair of Therapy and Cardiology, Associate Professor


References

1. Vorobyeva NM, Tkacheva ON. Anticoagulant therapy in “fragile” elderly patients: current state of the problem. Rational Pharmacotherapy in Cardiology. 2018;14(6):908-16 (In Russ.) doi:10.20996/1819-6446-2018-14-6-908-916.

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

3. 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.

4. Fried LP, Tangen CM, Walston J, et al.; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146-56. doi:10.1093/gerona/56.3.m146.

5. Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008;8:24. doi:10.1186/1471-2318-8-24.

6. Bel'diev SN, Platonov DJu. A typical mistake in prescribing rivaroxaban to elderly patients with atrial fibrillation. Russian Heart Journal. 2017;16(3):207-12 (In Russ.) doi:10.18087/rhj.2017.3.2345.

7. Halvorsen S, Atar D, Yang H, et al. Efficacy and safety of apixaban compared with warfarin according to age for stroke prevention in atrial fibrillation: observations from the ARISTOTLE trial. Eur Heart J. 2014;35(28):1864-72. doi:10.1093/eurheartj/ehu046.

8. Eikelboom JW, Wallentin L, Connolly SJ, 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. doi:10.1161/CIRCULATIONAHA.110.004747.

9. Halperin JL, Hankey GJ, Wojdyla DM, et al. 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.

10. Lauw MN, Eikelboom JW1, Coppens M, et al. Effects of dabigatran according to age in atrial fibrillation. Heart. 2017;103(13):1015-23. doi:10.1136/heartjnl-2016-310358.

11. 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. J Am Heart Assoc. 2018 Apr 13;7(8):e008643. doi:10.1161/JAHA.118.008643.

12. Martsevich SYu, Kutishenko NP. Randomized clinical trials and observational studies: the ratio in the hierarchy of evidence of the efficacy of drugs. Rational Pharmacotherapy in Cardiology. 2016;12(5):567-73 (In Russ.) doi:10.20996/1819-6446-2016-12-5-567-573.

13. Martsevich SYu, Lukina YV, Kutishenko NP. Once again about the hierarchy of evidences in medicine or whether it is possible to choose the most effective and safe drug with the help of observational studies. Rational Pharmacotherapy in Cardiology. 2017;13(2):270-4 (In Russ.) doi:10.20996/1819-6446-2017-13-2-270-274.

14. Arutyunov GP, Arhipov MV, Bakalov IN, et al. Place and significance of observational studies of NOACs in patients with non-valvular atrial fibrillation from the standpoint of evidence-based medicine. Russian Heart Journal. 2016;15(6):441-7 (In Russ.) doi:10.18087/rhj.2016.6.2297.

15. US Food and Drug Administration. Pradaxa (dabigatran etexilate mesylate): full prescribing information. Revised: 03/2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022512s035lbl.pdf. Accessed by March 3, 2019.

16. The State Register of Medical Products. Pradaxa prescribing information (In Russ.) [Государственный реестр лекарственных средств. Инструкция по применению лекарственного препарата для медицинского применения Прадакса]. Available at: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=bb76178c-cf95-4cbd-9883-6ba08ccb508d&t=. Accessed by March 3, 2019.

17. Coleman CI, Turpie A, Bunz TJ, Sood N. Effectiveness and safety of apixaban, dabigatran and rivaroxaban versus warfarin in frail patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2018 March 20;71(S11):A290. doi:10.1016/S0735-1097(18)30831-3.


Supplementary files

1. Рисунок 1. Эффективность и безопасность ППОАК по сравнению с варфарином у «хрупких» пациентов с ФП
Subject
Type Исследовательские инструменты
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For citations:


Bel'diev S.N., Medvedeva I.V., Platonov D.Yu., Trufanova G.Yu. Studies of Anticoagulant Therapy in Frail Elderly Patients: Problems of Terminology and Methodology. Rational Pharmacotherapy in Cardiology. 2019;15(2).

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