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Comparación del riesgo a corto plazo de hemorragias y eventos tromboembólicos en pacientes con fibrilación auricular

Géric Maura¹, Pierre-Olivier Blotière², Kim Bouillon²

¹From Strategy and Research Department, National Health Insurance (CNAMTS), Paris, France (G.M., P.-O.B., C.B., P.R., F.A.); and Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France (K.B., M.Z.). geric.maura@cnamts.fr.

|July 23, 2015

Resumen

Este estudio encontró que los nuevos usuarios de dabigatrán o rivaroxabán tenían riesgos similares de hemorragia y eventos tromboembólicos arteriales en comparación con warfarina en pacientes con fibrilación auricular no valvular. Los médicos deben considerar cuidadosamente la elección del anticoagulante para estos pacientes.

Área de la Ciencia:

Cardiología
Farmacología
Salud pública

Sus antecedentes:

Los anticoagulantes orales no antagonistas de la vitamina K (NOAC) como el dabigatrán y el rivaroxabán son alternativas a los antagonistas de la vitamina K (VKA) para la prevención del ictus en la fibrilación auricular no valvular (FANV).
Los primeros datos de seguridad y eficacia de los NOAC en comparación con los VKA en poblaciones de pacientes reales son cruciales para la toma de decisiones clínicas.

Objetivo del estudio:

Comparar la seguridad y la eficacia de dabigatrán y rivaroxabán frente a los ACV en pacientes naíves a los anticoagulantes con NVAF durante la fase inicial del tratamiento.
Evaluar los riesgos de hemorragia y eventos tromboembólicos arteriales asociados con estas clases de anticoagulantes.

Principales métodos:

Estudio de cohorte a nivel nacional basado en las bases de datos médicoadministrativas francesas (SNIIRAM y PMSI).
Inclución de pacientes con NVAF no tratados con anticoagulantes que iniciaron el tratamiento con dabigatrán, rivaroxabán o VKA entre 2011 y 2012.
Propensión 1: 2 de los nuevos usuarios de NOAC a los nuevos usuarios de VKA, con seguimiento hasta 90 días.

Principales resultados:

No se observó ninguna diferencia estadísticamente significativa en el riesgo de hemorragia o tromboembolismo entre los nuevos usuarios de dabigatrán y de VKA.
Los riesgos hemorrágicos e isquémicos fueron comparables entre los nuevos usuarios de rivaroxaban y VKA.
El estudio incluyó a más de 19.000 usuarios de VKA, 8.000 usuarios de dabigatrán y 4.000 usuarios de rivaroxabán, con cohortes coincidentes.

Conclusiones:

La iniciación de dabigatrán o rivaroxabán en pacientes con NVAF no tratados con anticoagulantes parece tener perfiles de seguridad y eficacia comparables a los de VKA durante el tratamiento inicial.
Los médicos deben tener precaución y tener en cuenta los factores individuales del paciente al iniciar cualquier anticoagulante oral, incluidos los NOAC y los VKA.

Palabras clave:

El Reino Unido Agentes anticoagulantes Fibrilación auricular Investigación comparativa de la eficacia las bases de datos, hechos hemorragia en el cuerpo Farmacoepidemiología el golpe

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