Definición de alto riesgo de hemorragia en pacientes sometidos a intervención coronaria percutánea
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Ver abstracta en PubMed
Resumen
Este resumen es generado por máquina.La normalización de la definición de alto riesgo de hemorragia es crucial para los pacientes sometidos a una intervención coronaria percutánea. El Consorcio de Investigación Académica para el Alto Riesgo de Sangrado (ARC-HBR) desarrolló una definición de consenso para mejorar los ensayos clínicos y la toma de decisiones.
Área De La Ciencia
- Cardiología
- Ensayos clínicos
- Reglamento de los productos sanitarios
Sus Antecedentes
- La falta de una definición estandarizada para el alto riesgo de hemorragia (HBR) en la intervención coronaria percutánea (PCI) dificulta los ensayos clínicos y la toma de decisiones.
- La identificación y el manejo de pacientes con HBR son críticos para los procedimientos de PCI.
Objetivo Del Estudio
- Desarrollar una definición de consenso para los pacientes con alto riesgo de hemorragia sometidos a PCI.
- Proporcionar consistencia para el diseño de ensayos clínicos, la interpretación de los datos y la revisión reglamentaria.
Principales Métodos
- Convocó al Consorcio de Investigación Académica para el Alto Riesgo de Sangrado (ARC-HBR), compuesto por expertos internacionales, autoridades reguladoras y observadores de la industria.
- Realizó dos reuniones de consenso en abril de 2018 (Washington, DC) y octubre de 2018 (París, Francia).
- Se examinaron las pruebas disponibles para establecer una definición pragmática de HBR.
Principales Resultados
- Desarrolló una definición de consenso para pacientes con alto riesgo de hemorragia sometidos a PCI.
- La definición tiene como objetivo estandarizar la identificación de pacientes con HBR en ensayos clínicos.
Conclusiones
- La definición de consenso ARC-HBR propuesta ofrece un enfoque pragmático para identificar consistentemente a los pacientes con HBR.
- Esta definición mejorará la coherencia de los ensayos clínicos, la toma de decisiones sobre la ayuda y apoyará la revisión reguladora de las intervenciones de ICP.
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