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Efecto de la terapia anticoagulante durante 6 semanas frente a 3 meses en la recurrencia y los eventos de sangrado en
Neil A Goldenberg1,2,3, John M Kittelson4,5, Thomas C Abshire6
1Institute for Clinical and Translational Research, Cancer and Blood Disorder Institute, and Heart Institute, Johns Hopkins All Children's Hospital, St Petersburg, Florida.
JAMA
|January 11, 2022
Resumen
Para los niños y adolescentes con tromboembolismo venoso provocado, una duración de tratamiento con anticoagulantes de 6 semanas es tan segura y efectiva como una duración de 3 meses. Este tratamiento más corto reduce el riesgo de hemorragia sin aumentar el riesgo de recurrencia.
Área de la Ciencia:
- Hematología pediátrica
- Medicina cardiovascular
- Ensayos clínicos
Sus antecedentes:
- La duración óptima del tratamiento con anticoagulantes para el tromboembolismo venoso (TEV) pediátrico no está bien establecida.
- La TEV provocada en pacientes menores de 21 años requiere una investigación adicional con respecto a la duración del tratamiento.
Objetivo del estudio:
- Determinar si el tratamiento anticoagulante de 6 semanas no es inferior al tratamiento de 3 meses para la TEV provocada en pacientes menores de 21 años.
- Evaluar la compensación entre los eventos de TEV recurrente y sangrado con diferentes duraciones de anticoagulantes.
Principales métodos:
- Un ensayo clínico aleatorizado en el que participaron 417 pacientes pediátricos con TEV aguda provocada en 42 centros internacionales.
- Los pacientes fueron asignados al azar a 6 semanas o 3 meses de tratamiento con anticoagulantes.
- Los resultados primarios incluyeron ETV recurrente sintomática y eventos de sangrado clínicamente relevantes dentro de 1 año, con análisis de no inferioridad en la población por protocolo.
Principales resultados:
- Se demostró la no inferioridad, con una incidencia acumulada a 1 año de TEV recurrente del 0,66% durante 6 semanas frente al 0,70% durante 3 meses.
- La incidencia de sangrado clínicamente relevante fue del 0,65% durante 6 semanas frente al 0,70% durante 3 meses.
- Se observaron menos eventos adversos en el grupo de 6 semanas (26%) en comparación con el grupo de 3 meses (32%).
Conclusiones:
- El tratamiento anticoagulante de seis semanas para la TEV provocada en pacientes menores de 21 años no es inferior al tratamiento de 3 meses.
- El tratamiento de menor duración demostró un equilibrio favorable entre la recurrencia de TEV y el riesgo de hemorragia.
- Estos hallazgos apoyan una duración más corta del tratamiento con anticoagulantes en la TEV pediátrica provocada.
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