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Rivaroxaban para la prevención de eventos trombóticos, hospitalización y muerte en pacientes ambulatorios con
Gregory Piazza1, Alex C Spyropoulos2,3,4, Judith Hsia5,6
1Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (G.P.).
Circulation
|May 8, 2023
Resumen
El rivaroxaban profiláctico no redujo los eventos trombóticos importantes, la hospitalización o la muerte en pacientes con COVID-19 que no fueron hospitalizados. El ensayo PREVENT-HD se detuvo antes de tiempo debido a las bajas tasas de eventos y los desafíos de inscripción.
Área de la Ciencia:
- Cardiología
- Enfermedades infecciosas
- Hematología
Sus antecedentes:
- El COVID-19 aumenta los riesgos de trombosis venosa y arterial y de insuficiencia respiratoria.
- Es crucial evaluar los beneficios de la anticoagulación profiláctica en pacientes con COVID-19 que no están hospitalizados.
Objetivo del estudio:
- Evaluar si la anticoagulación profiláctica con rivaroxaban reduce la trombosis, la hospitalización o la muerte en pacientes con COVID-19 de alto riesgo y no hospitalizados.
Principales métodos:
- El ensayo PREVENT-HD fue un estudio doble ciego controlado con placebo de 1284 pacientes con COVID-19 no hospitalizados.
- Los pacientes recibieron diariamente rivaroxabán (10 mg) o placebo durante 35 días.
- Resultado primario: compuesto de eventos trombóticos, hospitalización o muerte; Seguridad: sangrado en el sitio crítico o fatal.
Principales resultados:
- El estudio se terminó prematuramente debido a los desafíos de inscripción y las bajas tasas de eventos.
- En el grupo de Rivaroxaban: incidencia del 3,4%; en el grupo de placebo: incidencia del 3,0% (HR, 1,16; P=0,63).
- No se produjeron hemorragias críticas o fatales, sino una hemorragia mayor en el grupo de rivaroxabán.
Conclusiones:
- Rivaroxaban no redujo significativamente el resultado compuesto en pacientes no hospitalizados con COVID-19 con riesgo de trombosis.
- El término prematuro del juicio limitó las conclusiones definitivas.
- Puede ser necesario realizar más investigaciones para aclarar el papel de la anticoagulación en esta población.
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