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Resultados de tres años con el andamio biorresorbible de ABSORB: metaanálisis de datos de pacientes individuales de
Ziad A Ali1,2, Runlin Gao3, Takeshi Kimura4
1New York-Presbyterian Hospital/Columbia University Medical Center, New York (Z.A.A., G.W.S.).
Circulation
|November 2, 2017
Resumen
El andamio vascular bioresorbible de Absorb (BVS) mostró tasas más altas de falla de la lesión objetivo y trombosis del dispositivo en comparación con los stents de cobalto-cromo durante 3 años. Estos riesgos fueron particularmente elevados entre los años 1 y 3, lo que afectó a los resultados de seguridad del paciente.
Área de la Ciencia:
- Medicina cardiovascular
- Ciencia de los biomateriales
- Cardiología intervencionista
Sus antecedentes:
- El andamio vascular biorresorbible de Absorb (BVS) está diseñado para la reabsorción completa dentro de los 3 años posteriores a la implantación.
- El perfil de seguridad y eficacia a largo plazo de BVS durante este período crítico de 3 años requirió una caracterización detallada.
Objetivo del estudio:
- Para llevar a cabo un metaanálisis agrupado de los datos de pacientes individuales de los ensayos ABSORB.
- Evaluar la seguridad y eficacia del Absorb BVS a los 3 años en comparación con los stents de cobalto-cromo everolimus.
Principales métodos:
- Metaanálisis combinado de datos de pacientes individuales de 4 ensayos aleatorizados de ABSORB.
- Inclusión de 3389 pacientes con enfermedad arterial coronaria asignados al azar a Absorb BVS o a stents de cobalto-cromo everolimus.
- Resultados primarios: fallo de la lesión objetivo y trombosis del dispositivo.
Principales resultados:
- Las BVS demostraron tasas más altas de fallo de la lesión objetivo a los 3 años (11,7% frente a 8,1%) y trombosis del dispositivo (2,4% frente a 0,6%) en comparación con los stents de cobalto-cromo.
- El aumento del infarto de miocardio en los vasos diana y la revascularización inducida por isquemia contribuyeron a una mayor insuficiencia de la lesión diana con BVS.
- Se observaron tasas elevadas de insuficiencia de la lesión diana y trombosis del dispositivo con BVS específicamente entre los años 1 y 3.
Conclusiones:
- El Absorb BVS está asociado con un mayor riesgo de fallo de la lesión diana y trombosis del dispositivo hasta 3 años después de la implantación.
- Estos hallazgos ponen de relieve las posibles preocupaciones de seguridad con BVS, particularmente en el período de seguimiento posterior.
- La comparación con los stents con everolimus de cobalto-cromo indica un perfil de riesgo menos favorable para el BVS después de 1 año.
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