¿A la vista el final del sintrón?.

La anticoagulación con sintrón o warfarina, es de elección en los numerosos pacientes con fibrilación auricular y riesgo incrementado de tromboembolismo, esto es la mayoria de ellos. Sin embargo su utilización conlleva un riesgo incrementado de incidentes hemorragicos, algunos de ellos serios como la hemorragia intracerebral. Además, su utilizacion conlleva numerosos inconvenientes como son la necesidad de ajustes periodicos de la dosis utilizada y las numerosas interacciones de los anticoagulantes orales con otros fármacos.

La publicación el número del 17 de septiembre del NEJM del estudio Dabigatran versus Warfarin in Patients with Atrial Fibrillation supone un importante acontecimiento que puede modificar favorablmente la situación, igualando la eficacia de un nuevo fármaco y, además, disminuyendo los incidentes hemorrágicos y simplificando extraordinariamente el manejo de la terapeutica farmacológica, ya que no existe la necesidad de cont roles periodicos. A pesar de que los expertos señalan la necesidad de prudencia, ya que es necesario demostrar la seguridad del farmaco en condiciones clinicas reales fuera de los ensayos clinicos ( El antecedente de la retirada del Ximelagatran, ya en la fase de comercialización el algunos paises europeos) , la publicación de este ensayo es una magnifica noticia.

N Engl J Med. 2009 Sep 17;361(12):1139-51. Epub 2009 Aug 30.
Dabigatran versus warfarin in patients with atrial fibrillation.

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators.

Collaborators (1725)
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. connostu@phri.ca
Comment in:

N Engl J Med. 2009 Sep 17;361(12):1200-2.
BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 2009 Massachusetts Medical Society