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Rivaroxaban versus enoxaparin para la tromboprofilaxis después de la artroplastia total de rodilla (RECORD4): un
Alexander G G Turpie1, Michael R Lassen, Bruce L Davidson
1McMaster University, Hamilton, Ontario L8L 2X2, Canada. turpiea@mcmaster.ca
Lancet (London, England)
|May 5, 2009
Resumen
El rivaroxaban oral demostró una eficacia superior en la prevención del tromboembolismo venoso después de la artroplastia total de rodilla en comparación con la enoxaparina. Este estudio apoya estancias hospitalarias más cortas con profilaxis oral efectiva para pacientes sometidos a cirugía de reemplazo de rodilla.
Área de la Ciencia:
- Cirugía Ortopédica en Cirugía Ortopédica.
- Farmacología Farmacología.
- La medicina vascular es una medicina vascular.
Sus antecedentes:
- La profilaxis del tromboembolismo venoso (TEV) es estándar después de la artroplastia total de rodilla (TKA).
- Los anticoagulantes orales pueden facilitar estancias hospitalarias más cortas.
- Se investigó la eficacia y seguridad del rivaroxaban oral para la profilaxis de TKA VTE.
Objetivo del estudio:
- Evaluar la eficacia del rivaroxaban oral en comparación con la enoxaparina para la prevención de TEV después de la TKA.
- Para evaluar el perfil de seguridad, específicamente los eventos de sangrado mayor, asociados con rivaroxaban.
Principales métodos:
- Un ensayo aleatorizado, doble ciego, de fase III en el que participaron 3148 pacientes sometidos a TKA.
- Los pacientes recibieron rivaroxaban oral (10 mg al día) o enoxaparina subcutánea (30 mg dos veces al día).
- La venografía obligatoria se realizó entre los días 11-15; la eficacia primaria fue la TEV compuesta o la muerte, la seguridad primaria fue el sangrado mayor.
Principales resultados:
- Rivaroxaban mostró una reducción estadísticamente significativa en los eventos de TEV (6,9% frente a 10,1%, p=0,0118).
- Se produjo un sangrado mayor en el 0,7% de los pacientes con rivaroxaban y en el 0,3% de los pacientes con enoxaparina (p=0,1096).
- Se encontró que el rivaroxaban no era inferior y era superior en eficacia a la enoxaparina.
Conclusiones:
- El rivaroxaban oral (10 mg una vez al día durante 10-14 días) es una opción superior para la prevención de TEV después de TKA.
- Los hallazgos apoyan el uso de anticoagulantes orales para mejorar la recuperación del paciente y las hospitalizaciones potencialmente más cortas.
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