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Open Access 05.06.2020 | Original Research Article

A Structured Literature Review and International Consensus Validation of FORTA Labels of Oral Anticoagulants for Long-Term Treatment of Atrial Fibrillation in Older Patients (OAC-FORTA 2019)

verfasst von: Farhad Pazan, Ronan Collins, Victor M. Gil, Olivier Hanon, Roland Hardt, Martin Hoffmeister, Pedro Monteiro, Terence J. Quinn, Dieter Ropers, Giuseppe Sergi, Freek W. A. Verheugt, Martin Wehling

Erschienen in: Drugs & Aging | Ausgabe 7/2020

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Abstract

Introduction

Evidence regarding safety and efficacy of oral anticoagulants for the treatment of atrial fibrillation (AFib) in older adults has been assessed regarding the age appropriateness of oral anticoagulants (OAC) according to the FORTA (Fit fOR The Aged) classification (OAC-FORTA). Three years after its first version (OAC-FORTA 2016), an update was initiated to create OAC-FORTA 2019.

Methods

A structured review of randomized controlled clinical trials and summaries of individual product characteristics was performed to detect newly emerged evidence on oral anticoagulants in older patients with AFib. This review was used by an interdisciplinary panel of European experts (N = 10) in a Delphi process to label OACs according to FORTA.

Results

A total of 202 records were identified and 11 studies finally included. We found four new trials providing relevant data on efficacy and safety of warfarin, apixaban, dabigatran or rivaroxaban in older patients with AFib. In the majority of studies comparing the non-vitamin-K oral anticoagulants (NOACs) with warfarin, NOACs were superior to warfarin regarding at least one relevant clinical endpoint. The mean consensus coefficient significantly increased from 0.867 (OAC-FORTA 2016) to 0.931 (p < 0.05) and the proposed FORTA classes were confirmed in all cases during the first round (consensus coefficient > 0.8). Warfarin, dabigatran, edoxaban and rivaroxaban were assigned to the FORTA B label, acenocoumarol, fluindione and phenprocoumon were labeled FORTA C and only apixaban was rated as FORTA A.

Conclusion

OAC-FORTA 2019 confirms that AFib can be successfully treated with positively labeled antithrombotics at advanced age.

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Zoni-Berisso M, Lercari F, Carazza T, et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213–20.PubMedPubMedCentralCrossRef

Zathar Z, Karunatilleke A, Fawzy AM, et al. Atrial fibrillation in older people: concepts and controversies. Front Med (Lausanne). 2019;6:175.PubMedPubMedCentralCrossRef

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22:983–8.PubMedCrossRef

Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857–67.PubMedCrossRef

Wehling M, Collins R, Gil VM, et al. Appropriateness of oral anticoagulants for the long-term treatment of atrial fibrillation in older people: results of an evidence-based review and international consensus validation process (OAC-FORTA 2016). Drugs Aging. 2017;34:499–507.PubMedCrossRef

Mitrousi K, Lip GYH, Apostolakis S. Age as a risk factor for stroke in atrial fibrillation patients: implications in thromboprophylaxis in the era of novel oral anticoagulants. J Atr Fibril. 2013;6:783.

Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893–962.PubMedCrossRef

Fialová D, Kummer I, Držaić M, Leppee M. Ageism in medication use in older patients. In: Ayalon L, Tesch-Römer C, editors. Contemporary perspectives on ageism. international perspectives on aging, vol. 19. Cham: Springer; 2018.

Wehling M. Drug therapy in the elderly: too much or too little, what to do? A new assessment system: fit for the aged (FORTA) [in German]. Dtsch Med Wochenschr. 2008;133:2289–91.PubMedCrossRef

10.

Wehling M. Multimorbidity and polypharmacy: how to reduce the harmful drug load and yet add needed drugs in the elderly? Proposal of a new drug classification: fit for the aged. J Am Geriatr Soc. 2009;57:560–1.PubMedCrossRef

11.

Kuhn-Thiel AM, Weiß C, Wehling M. Consensus validation of the FORTA (Fit fOR The Aged) List: a clinical tool for increasing the appropriateness of pharmacotherapy in the elderly. Drugs Aging. 2014;31:131–40.PubMedCrossRef

12.

Pazan F, Weiss C, Wehling M. The FORTA (Fit fOR The Aged) list 2018: third version of a validated clinical tool for improved drug treatment in older people. Drugs Aging. 2019;36:481–4.PubMedCrossRef

13.

Wehling M, Burkhardt H, Kuhn-Thiel AM, Pazan F, Throm C, Weiss C, Frohnhofen H. VALFORTA—a randomized trial to validate the FORTA (“Fit fOR The Aged”) classification. Age Ageing. 2016;45:262–7.PubMedCrossRef

14.

Pazan F, Weiss C, Wehling M. The EURO-FORTA (Fit fOR The Aged) List: international consensus validation of a clinical tool for improved drug treatment in older people. Drugs Aging. 2018;35:61–71.PubMedCrossRef

15.

Pazan F, Gercke Y, Weiss C, et al. The US-FORTA (Fit fOR The Aged) List: consensus validation of a clinical tool to improve drug therapy in older adults. J Am Med Dir Assoc. 2020;21:439.PubMedCrossRef

16.

Oxford Centre for Evidence-based Medicine—Levels of Evidence 2009. https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/. Accessed 19 Mar 2020.

17.

Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.PubMedCrossRef

18.

Cicchetti DV, Allison T. A new procedure for assessing reliability of scoring EEG sleep recordings. Am J EEG Technol. 1971;11:101–9.CrossRef

19.

Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika. 1965;52:591–611.CrossRef

20.

Barnett AS, Cyr DD, Goodman SG, et al. Net clinical benefit of rivaroxaban compared with warfarin in atrial fibrillation: results from ROCKET AF. Int J Cardiol. 2018;257:78–83.PubMedCrossRef

21.

Lopes RD, Heizer G, Aronson R, et al. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med. 2019;380:1509–24.PubMedCrossRef

22.

Lopes RD, Guimarães PO, Kolls BJ, et al. Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy. Blood. 2017;129:2980–7.PubMedCrossRef

23.

Alexander JH, Andersson U, Lopes RD, et al. Apixaban 5 mg twice daily and clinical outcomes in patients with atrial fibrillation and advanced age, low body weight, or high creatinine: a secondary analysis of a randomized clinical trial. JAMA Cardiol. 2016;1:673–81.PubMedCrossRef

24.

Cannon CP, Bhatt DL, Oldgren J, et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med. 2017;377:1513–24.PubMedCrossRef

25.

Lauw MN, Eikelboom JW, Coppens M, et al. Effects of dabigatran according to age in atrial fibrillation. Heart. 2017;103:1015–23.PubMedCrossRef

26.

Gibson CM, Mehran R, Bode C, et al. Prevention of bleeding in patients with atrial fibrillation undergoing PCI. N Engl J Med. 2016;375:2423–34.PubMedCrossRef

27.

Gibson CM, Pinto DS, Chi G, et al. Recurrent hospitalization among patients with atrial fibrillation undergoing intracoronary stenting treated with 2 treatment strategies of rivaroxaban or a dose-adjusted oral vitamin K antagonist treatment strategy. Circulation. 2017;135:323–33.PubMedPubMedCentralCrossRef

28.

Reddy VY, Doshi SK, Kar S, et al. 5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials. J Am Coll Cardiol. 2017;70:2964–75.PubMedCrossRef

29.

Kato ET, Giugliano RP, Ruff CT, et al. Efficacy and safety of edoxaban in elderly patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. J Am Heart Assoc. 2016;5:e003432.PubMedPubMedCentralCrossRef

30.

Steffel J, Giugliano RP, Braunwald E, et al. Edoxaban versus warfarin in atrial fibrillation patients at risk of falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016;68:1169–78.PubMedCrossRef

31.

Vranckx P, Valgimigli M, Eckardt L, et al. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019;394:1335–43.PubMedCrossRef

32.

Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104.PubMedCrossRef

33.

Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.PubMedCrossRef

34.

Rao MP, Vinereanu D, Wojdyla DM, et al. clinical outcomes and history of fall in patients with atrial fibrillation treated with oral anticoagulation: insights from the ARISTOTLE trial. Am J Med. 2018;131:269–75.PubMedCrossRef

35.

Monelli M, Molteni M, Cassetti G, et al. Non-vitamin K oral anticoagulant use in the elderly: a prospective real-world study—data from the REGIstry of patients on non-vitamin K oral Anticoagulants (REGINA). Vasc Health Risk Manag. 2019;15:19–25.PubMedPubMedCentralCrossRef

36.

Patti G, Pecen L, Lucerna M, et al. Net clinical benefit of non-vitamin K antagonist vs vitamin K antagonist anticoagulants in elderly patients with atrial fibrillation. Am J Med. 2019;132:749–57.PubMedCrossRef

37.

Halvorsen S, Ghanima W, Fride Tvete I, et al. A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants. Eur Heart J Cardiovasc Pharmacother. 2017;3:28–36.PubMedCrossRef

38.

Haas S, Camm AJ, Bassand JP, et al. Predictors of NOAC versus VKA use for stroke prevention in patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF. Am Heart J. 2019;213:35–46.PubMedCrossRef

39.

Mazurek M, Halperin JL, Huisman MV, et al. Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme. Europace. 2020;22:47–57.PubMed

40.

Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131:157–64.PubMedCrossRef

41.

Hohnloser SH, Basic E, Hohmann C, et al. Effectiveness and safety of non-vitamin K oral anticoagulants in comparison to phenprocoumon: data from 61,000 patients with atrial fibrillation. Thromb Haemost. 2018;118:526–38.PubMedCrossRef

42.

Veronese N, Argusti A, Canepa E, et al. Evaluating the effectiveness and risks of oral anticoagulant treatments in multimorbid frail older subjects with atrial fibrillation using the multidimensional prognostic index: the EURopean study of older subjects with atrial fibrillation—EUROSAF. Eur Geriatr Med. 2019;9:149–54.CrossRef

Titel: A Structured Literature Review and International Consensus Validation of FORTA Labels of Oral Anticoagulants for Long-Term Treatment of Atrial Fibrillation in Older Patients (OAC-FORTA 2019)
verfasst von: Farhad Pazan
Ronan Collins
Victor M. Gil
Olivier Hanon
Roland Hardt
Martin Hoffmeister
Pedro Monteiro
Terence J. Quinn
Dieter Ropers
Giuseppe Sergi
Freek W. A. Verheugt
Martin Wehling
Publikationsdatum: 05.06.2020
Verlag: Springer International Publishing
Erschienen in: Drugs & Aging / Ausgabe 7/2020
Print ISSN: 1170-229X
Elektronische ISSN: 1179-1969
DOI: https://doi.org/10.1007/s40266-020-00771-0

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A Structured Literature Review and International Consensus Validation of FORTA Labels of Oral Anticoagulants for Long-Term Treatment of Atrial Fibrillation in Older Patients (OAC-FORTA 2019)