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Edoxaban durante 12 meses frente a 3 meses en pacientes con cáncer con trombosis distal profunda aislada (estudio
Yugo Yamashita1, Takeshi Morimoto2, Nao Muraoka3
1Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y. Yamashita, Y. Yoshikawa).
Circulation
|August 28, 2023
Resumen
En pacientes con cáncer con trombosis venosa profunda distal aislada, el tratamiento con edoxaban durante 12 meses redujo significativamente los eventos de tromboembolismo venoso recurrente (TEV) en comparación con el tratamiento durante 3 meses, con tasas de sangrado importantes similares.
Área de la Ciencia:
- Hematología
- En el campo de la oncología
- Ensayos clínicos
Sus antecedentes:
- La duración óptima de la anticoagulación para la trombosis venosa profunda distal (TVP) aislada en pacientes con cáncer no está clara.
- El tratamiento prolongado puede prevenir la trombosis pero aumentar el riesgo de hemorragia.
Objetivo del estudio:
- Comparar la eficacia y la seguridad del tratamiento con edoxaban durante 12 meses frente a 3 meses para la TVP distal aislada en pacientes con cáncer.
- Evaluar el criterio de valoración primario de tromboembolismo venoso recurrente (TEV) o muerte relacionada con TEV a los 12 meses.
Principales métodos:
- Un ensayo clínico multicéntrico aleatorizado en el que participaron 601 pacientes con cáncer con TVP distal aislada.
- Los pacientes recibieron tratamiento con edoxaban durante 12 o 3 meses.
- El criterio de valoración primario: compuesto de TEV recurrente sintomática o muerte relacionada con TEV; el criterio de valoración secundario: hemorragia mayor.
Principales resultados:
- Edoxaban a los 12 meses redujo significativamente el recurrente sintomático de TEV o la muerte relacionada con TEV (1, 0% frente a 7, 2%; OR, 0, 13; IC del 95%, 0,03-0, 44).
- Las tasas de hemorragia mayor fueron similares entre los grupos de 12 meses (9,5%) y 3 meses (7,2%) (OR, 1,34; IC del 95%, 0,75- 2,41).
Conclusiones:
- Doce meses de tratamiento con edoxaban es superior a 3 meses para prevenir la recidiva de TEV o la muerte relacionada con TEV en pacientes con cáncer con TVP distal aislada.
- La anticoagulación prolongada con edoxaban parece segura en esta población de pacientes.
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