Revista Española de Cardiología Revista Española de Cardiología
Rev Esp Cardiol Supl. 2012;12(B):25-30 - Vol. 12 Núm.Supl.B DOI: 10.1016/S1131-3587(12)70048-1

Evidencias clínicas del estudio RE-LY en la prevención de ictus y tromboembolia por fibrilación auricular

Antoni Martínez-Rubioa,, Eva Guillaumet Gasaa, Nuria Casanovas Marbàa, Fina Orúsa, Laura Guillamón Torána

a Departamento de Cardiología, Hospital de Sabadell, Universidad Autónoma de Barcelona, Barcelona, España

Palabras clave

Anticoagulación. Fibrilación auricular. Hemorragia. Ictus.

Resumen

La fibrilación auricular es una arritmia que aumenta la probabilidad de sufrir un ictus por tromboembolia. Por ello, el control apropiado de la coagulación debe prevenir tanto estos efectos tromboembólicos como las complicaciones hemorrágicas derivadas del tratamiento anticoagulante. Se dispone ya de los datos clínicos de fase III con el nuevo anticoagulante oral dabigatrán. Los efectos de dos dosis (110mg/12h y 150mg/12h) de este fármaco se compararon con los de warfarina (estudio RE-LY). En este artículo se exponen los resultados principales de ese ensayo clínico. Los resultados indican que el fármaco en dosis de 110mg/12h es equivalente a la warfarina respecto a la eficacia y superior en cuanto a la seguridad. La dosis de 150mg/12h es más eficaz que la warfarina para la prevención de tromboembolias, con una seguridad parecida a la de la warfarina. Así pues, dabigatrán es una alternativa al tratamiento con warfarina.

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Bibliografía

1.Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994; 154:1449-57.
2.Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: The Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study. JAMA. 2001; 285:2370-5.
Medline
3.Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation – executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with atrial fibrillation). Eur Heart J. 2006; 27:1979-2030.
Medline
4.Camm AJ, Kirchhof P, Lip GYH, Schotten U, Savelieva I, Ernst S, et al. Guidelines for the management of atrial fibrillation. Guidelines for the management of atrial fibrillation. The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Hear J. 2010; 31:2369-429.
5.Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin compared with dabigatran. Am Heart J. 2009; 157:805-10.
Medline
6.Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:1139-51.
Medline
7.Wolowacz SE, Roskell NS, Plumb JM, Caprini JA, Eriksson BI. Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. Thromb Haemost. 2009; 101:77-85.
8.Sanford M, Plosker GL. Dabigatran etexilate. Drugs. 2008; 68:1699-709.
9.Stangier J, Clemens A. Pharmacology, pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost. 2009; 15(Suppl 1):S9-S16.
10.Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L. Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial. N Engl J Med. 2010; 363:1875-6.
11.Connolly SJ, Pogue J, Eikelboom J, Flaker G, Commerford P, Franzosi MG, et al. Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation. 2008; 118:2029-37.
Medline
12.Sorensen SV, Kansal AR, Connolly S, Peng S, Linnehan J, Bradley-Kennedy C, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolismo in atrial fibrillation: a Canadian payer perspective. Thromb Haemost. 2011; 105:908-19.
Medline
13.Pink J, Lane S, Pirmohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitave Beneditharm and economic analises. BMJ. 2011; 343:d6333.
14.Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011; 123:2562-70.
15.Freeman JV, Zhu RP, Owens DK, Garber AM, Hutton DW, Go AS, et al. Costeffectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011; 154:1-11.
Medline
16.Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011; 124:1573-9.