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Una estrategia libre de aspirina versus doble antiplaquetaria para el stenting coronario: ensayo aleatorio STOPDAPT-3

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Una estrategia sin aspirina utilizando prasugrel en monoterapia no redujo las tasas de sangrado en comparación con la terapia doble antiplaquetaria (DAPT) después de la intervención coronaria percutánea (ICP). Si bien no es inferior para los eventos cardiovasculares, este enfoque mostró un aumento potencial en los eventos coronarios.

Palabras clave:
La aspirina también.tratamiento antiplaquetario dualIntervención coronaria por la piel

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Área de la Ciencia:

  • Cardiología
  • Cardiología intervencionista
  • Farmacología

Sus antecedentes:

  • Las altas tasas de hemorragia persisten con la terapia antiplaquetaria dual (DAPT) después de la intervención coronaria percutánea (ICP), especialmente en pacientes con síndrome coronario agudo (SAA) o con alto riesgo de hemorragia.
  • Las estrategias sin aspirina pueden reducir el sangrado precoz después de la ICP sin comprometer los resultados cardiovasculares, pero requieren validación en ensayos aleatorios.

Objetivo del estudio:

  • Evaluar la eficacia y seguridad de una estrategia de monoterapia con prasugrel sin aspirina en comparación con DAPT en pacientes sometidos a ICP.
  • Evaluar la superioridad para el sangrado mayor y la no inferioridad para los eventos cardiovasculares dentro de un mes después de la ICP.

Principales métodos:

  • Un ensayo aleatorizado en el que participaron 6002 pacientes con SCA o con alto riesgo de hemorragia sometidos a ICP.
  • Los pacientes fueron asignados a la monoterapia con prasugrel (grupo sin aspirina) o a la TDAP (aspirina más prasugrel).
  • Los parámetros de valoración primarios incluyeron hemorragias importantes y un conjunto de eventos cardiovasculares.

Principales resultados:

  • El grupo sin aspirina no fue superior en la reducción de la hemorragia mayor (4, 47% frente a 4, 71%), pero no fue inferior en los eventos cardiovasculares (4, 12% frente a 3, 69%) a 1 mes.
  • No se observaron diferencias significativas en los resultados clínicos adversos netos o en los componentes individuales del evento cardiovascular.
  • El grupo sin aspirina mostró una mayor incidencia de revascularización coronaria no planificada y trombosis subaguda del stent.

Conclusiones:

  • Una estrategia sin aspirina con una dosis baja de prasugrel no logró superioridad para el sangrado mayor después de la PCI en comparación con la TDAP.
  • La estrategia sin aspirina no fue inferior para los eventos cardiovasculares, pero llevó una señal de aumento de eventos coronarios, incluida la trombosis del stent.