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Vol. 66. Issue 6.
Pages 510-511 (June 2013)
Vol. 66. Issue 6.
Pages 510-511 (June 2013)
Letter to the Editor
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Self-management of Vitamin K Antagonists Is More Cost-effective Than Dabigatran for Stroke Prevention in Non-valvular Atrial Fibrillation in Spain
El autocontrol de la terapia con cumarínicos es más eficiente que dabigatrán para prevenir ictus en fibrilación auricular no valvular en España
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Juan C. Soutoa,
Corresponding author
jsouto@santpau.cat

Corresponding author:
, Xavier Ruyrab, Antoni Bayes-Genisc
a Unitat d’Hemostàsia i Trombosi, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
b Servicio de Cirugía Cardiaca, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
c Servicio de Cardiología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
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José R. González-Juanatey, José Álvarez-Sabin, José M. Lobos, Antoni Martínez-Rubio, Joan C. Reverter, Itziar Oyagüez, Nuria González-Rojas, Virginia Becerra
José R. González-Juanatey, José M. Lobos, Joan C. Reverter, Virginia Becerra
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To the Editor,

We read with great interest the article by González-Juanatey et al.1 on the cost-effectiveness of the new oral anticoagulant dabigatran compared with conventional oral anticoagulant therapy (OAT) in patients with nonvalvular atrial fibrillation. This study consisted of a simulation using modern computer models applied to the Spanish setting. It concluded that dabigatran would be an effective strategy for stroke prevention when compared with two different scenarios: 100% of patients on OAT, or the usual prescription pattern (60% on OAT, 30% on aspirin, and 10% untreated). The authors concluded that dabigatran is efficient because the increase in costs does not exceed 30 000 euros/quality-adjusted life year gained, an acceptability threshold proposed in 2002.1 Increases in the cost-effectiveness ratio would be 17 581 euros/quality-adjusted life year for the scenario in which 100% of patients received OAT and would be 14 118 euros/quality-adjusted life year when the usual prescription pattern was considered. These results rely exclusively on data from the RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) clinical trial, which compared dabigatran with OAT managed exclusively in specialist units on a monthly basis.2 However, while González-Juanatey et al.’s1 simulation takes into account the costs of different OAT management scenarios and includes weekly self-management, it does not consider the very different rate of serious complications observed depending on the model of OAT management used. For example, risk is clearly reduced by self-management compared with conventional OAT.3 Given the clinical and economic importance of these issues, clarification of some issues would seem opportune.

The design, procedure, and interpretation of the results of the RE-LY trial have attracted considerable criticism4; one of the major criticisms focused on the total lack of an advantage for dabigatran compared with conventional OAT when levels of international normalized ratio control, measured as the proportion of time in therapeutic range, are over 65% to 70%. It is unsurprising, therefore, that a recent publication5 which indirectly compared dabigatran and OAT self-management showed no significant difference in serious complications. On the contrary, there was a clear trend favoring self-management: the relative risk and its confidence intervals were 0.73 (0.48-1.10) for thromboembolism, 0.64 (0.40-1.01) for mortality, and 1.15 (0.83-1.60) for severe bleeding.5 Although direct comparative studies are lacking, these data should prompt health officials to rethink strategies for stroke prevention. Such a reevaluation is especially pertinent, given that 50% of patients receiving OAT in Spain can perform self-management with clinical guarantees6 and that a rigorous metaanalysis has confirmed the superiority of the self-management model over conventional OAT in specialized centers.3 Consequently, the last international consensus of the American College of Chest Physicians recommended OAT self-management as the model of choice.7

Furthermore, the current cost of self-control in Spain is 420 euros/year, including technology, reagents, supervision, and data centralization,8 and not 884 euros to 1221 euros/year as erroneously stated in the article by Gonzalez-Juanatey et al.1

Given the data presented, OAT self-management is clearly the most effective strategy for stroke prevention in patients with atrial fibrillation: its clinical outcomes are superior to those of conventional OAT and are not inferior to those of dabigatran. In addition, OAT self-management is highly cost-competitive compared with dabigatran (420 euros vs 1106 euros/year) and is competitive when compared with conventional control (420 euros vs 378-462 euros/year). The self-management model will therefore be the dominant pharmacoeconomic model (net savings) regardless of the type of analysis used.

Conflicts of interest

Juan Carlos Souto is the Scientific Director of Monitor Medical. He has received speaker's fees from Roche Diagnostics, Astra-Zeneca, and Sanofi-Aventis and reimbursement for attending conferences from Boehringer Ingelheim, Baxter, and Rovi. Xavier Ruyra is a consultant on valvular disease at Monitor Medical. Antoni Bayes-Genis has received reimbursement to attend meetings from Boehringer Ingelheim and Almirall and is a member of Monitor Medical's Scientific Advisory Board.

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References
[1]
J.R. González-Juanatey, J. Álvarez-Sabin, J.M. Lobos, A. Martínez-Rubio, J.C. Reverter, I. Oyagüez, et al.
Análisis de coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica en fibrilación auricular no valvular en España.
Rev Esp Cardiol, 65 (2012), pp. 901-910
[2]
S.J. Connolly, M.D. Ezekowitz, S. Yusuf, J. Eikelboom, J. Oldgren, A. Parekh, et al.
Dabigatran versus warfarin in patients with atrial fibrillation.
N Engl J Med, 361 (2009), pp. 1139-1151
[3]
C. Heneghan, A. Ward, R. Perera, The Self-Monitoring Trialist Collaboration.
Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.
[4]
J.J. DiNicolantonio.
Dabigatran or warfarin for the prevention of stroke in atrial fibrillation?. A closer look at the RE-LY trial.
Expert Opin Pharmacother, 13 (2012), pp. 807-814
[5]
P. Alonso-Coello, Qi Zhou, G. Guyatt.
Home-monitoring of oral anticoagulation vs. dabigatran.
Thromb Haemost, 108 (2012), pp. 647-653
[6]
B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, M. Quintana, I. Gich, et al.
Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.
Ann Intern Med, 142 (2005), pp. 1-10
[7]
G.H. Guyatt, E.A. Akl, M. Crowther, D.D. Gutterman, H.J. Schuünemann.
Executive summary. Antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians evidence-based clinical practice guidelines.
Chest, (2012), pp. S7-S47
[8]
Monitor Medical. Información corporativa 2011. Available at: http://www.monitormedical.es [accessed 4 Jan 2013].
Copyright © 2012. Sociedad Española de Cardiología
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