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Efecto de los inhibidores de P2Y12 en la supervivencia sin apoyo de órganos entre los pacientes hospitalizados con

Jeffrey S Berger¹, Lucy Z Kornblith², Michelle N Gong³

¹NYU Grossman School of Medicine, New York, New York.

|January 18, 2022

Resumen

La adición de un inhibidor de P2Y12 a la terapia con heparina no mejoró los días libres de soporte de órganos para los pacientes con COVID-19 que no estaban en estado crítico. Esta combinación terapéutica también mostró una tendencia al aumento de los eventos de hemorragia mayor, lo que sugiere que no hay un beneficio claro.

Área de la Ciencia:

Medicina cardiovascular
Enfermedades infecciosas
Ensayos clínicos

Sus antecedentes:

Las plaquetas están implicadas en la patogénesis del COVID-19 y representan un objetivo terapéutico potencial.
Comprender el papel de los agentes antiplaquetarios junto con la anticoagulación para el COVID-19 es crucial para optimizar los resultados de los pacientes.

Objetivo del estudio:

Investigar la eficacia y seguridad de agregar un inhibidor de P2Y12 a la terapia anticoagulante estándar en pacientes hospitalizados con COVID-19 que no están en estado crítico.
Para determinar si esta combinación mejora los resultados clínicos, específicamente los días libres de soporte de órganos.

Principales métodos:

Un ensayo clínico adaptativo, abierto y aleatorio en el que participaron 562 pacientes con COVID-19 que no estaban en estado crítico.
Los pacientes recibieron heparina terapéutica más un inhibidor de la P2Y12 (predominantemente ticagrelor) o heparina terapéutica sola (cuidado habitual).
El resultado primario fue días sin soporte de órganos dentro de los 21 días; el sangrado mayor fue el resultado primario de seguridad.

Principales resultados:

El número medio de días libres de soporte de órganos fue similar entre el grupo de inhibidores de P2Y12 (21 días) y el grupo de tratamiento habitual (21 días).
El estudio cumplió con su criterio de futilidad preespecificado para mejorar los días libres de soporte de órganos.
Se produjo una hemorragia mayor en el 2,0% del grupo de inhibidores de P2Y12 frente al 0,7% del grupo de tratamiento habitual, sin diferencias estadísticamente significativas.

Conclusiones:

La adición de un inhibidor de P2Y12 a la heparina terapéutica en pacientes con COVID-19 que no estaban en estado crítico no aumentó las probabilidades de mejora en los días libres de soporte de órganos.
La tendencia observada hacia un mayor riesgo de hemorragia justifica una cuidadosa consideración, y esta estrategia no se recomienda en base a la evidencia actual.
Es posible que se necesite más investigación para explorar subgrupos específicos de pacientes o estrategias alternativas antiplaquetarias en el manejo de COVID-19.

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