Guía de Práctica Clínica - Problema de Salud AUGE N°05
Infarto agudo del miocardio
Recomendación T6 – Juicio del Panel y Evidencia
T.6 En personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) tratados con trombolisis, el Ministerio de Salud RECOMIENDA realizar dentro de las primeras 48 horas del evento una coronariografía de rutina a todos los pacientes por sobre realizarla sólo a grupos seleccionados.
Comentarios del Panel de Expertos:
►Para identificar el centro de salud al cual derivar consultar documento Redes de Atención GES y No GES 2018 página 26 y Coordinación Cardiología de Alta Complejidad – Departamento Ges y Redes de Alta Complejidad (ver documentos relacionados)
►Se define coronariografía y angioplastía de rutina precoz como aquella que se realiza dentro de las primeras 48 hrs del evento.
El Panel de Expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.
A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
El problemade salud ha sido definido como prioritario de abordar a través de una Guía de Práctica Clínica por la División de Prevención y Control de Enfermedades del Ministerio de Salud. La pregunta ha sido priorizada por el equipo de esta Guía, ya sea porque existía variabilidad o incertidumbre.
| Trivial | Pequeño | Moderado | Grande | Varía | No lo sé |
|---|
Grandes: El equipo elaborador de la Guía estimó que los efectos deseables de «realizar coronariografía y eventual angioplastía de rutina precoz» en comparación a » realizarla sólo en caso de presentar síntomas o isquemia» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Evidencia de investigación
|
Coronariografía precoz versus manejo guiado por isquemia post-trombolisis en IAM con SDST. |
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|
Población |
Personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) tratados con trombolíticos |
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|
Intervención |
Coronariografía y eventual angioplastía de rutina precoz. |
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|
Comparación |
Realizarla sólo en caso de presentar síntomas o isquemia. |
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|
Desenlaces** |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
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|
Realizarla sólo en caso de presentar síntomas o isquemia |
Coronariografía y angioplastía rutinaria precoz |
Diferencia (IC 95%) |
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|
Mortalidad |
RR 0,80 (0,59 a 1,08) — 6 ensayos [34, 36, 42, 45, 49, 59] / 2410 pacientes |
78 por 1000 |
62 por 1000 |
Diferencia: 16 menos (32 menos a 6 más) |
⊕⊕⊕◯1 Moderada |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia probablemente disminuye la mortalidad. |
|
Reinfarto |
RR 0,64 (0,46 a 0,90) — 6 ensayos [34, 36, 42, 45, 49, 59] / 2410 pacientes |
70 por 1000 |
45 por 1000 |
Diferencia: 25 menos (7 a 38 menos) |
⊕⊕⊕⊕ Alta |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia disminuye el riesgo de reinfarto. |
|
Accidente cerebrovascular |
RR 0,60 (0,27 a 1,33) — 2 ensayos [42, 49] / 463 pacientes |
68 por 1000 |
41 por 1000 |
Diferencia: 27 menos (50 menos a 22 más) |
⊕⊕◯◯2 Baja |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia podría disminuir los accidentes cerebrovasculares, pero la certeza de la evidencia es baja. |
|
Hospitalización |
RR 0,93 (0,70 a 1,24) — 1 ensayo [59] / 984 pacientes |
165 por 1000 |
153 por 1000 |
Diferencia: 12 menos (49 menos a 40 más) |
⊕⊕◯◯2 Baja |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia podría disminuir los accidentes cerebrovasculares, pero la certeza de la evidencia es baja. |
|
Insuficiencia cardiaca |
El desenlace insuficiencia cardiaca no fue reportado. |
— |
— |
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Hemorragia |
El desenlace hemorragia no fue reportado. |
— |
— |
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IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON realizarla sólo en caso de presentar síntomas o isquemia está basado en el riesgo del grupo control en los estudios. El riesgo CON coronariografía y angioplastía precoz (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
**Seguimiento promedio 1 año.
1 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
2 Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión opuesta (intervalo de confianza muy amplio).
Fecha de elaboración de la tabla: Enero, 2019.
Referencia
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Pequeños: El equipo elaborador de la Guía estimó que los efectos indeseables de «realizar coronariografía y eventual angioplastía de rutina precoz» en comparación a » realizarla sólo en caso de presentar síntomas o isquemia» son pequeños, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Consideraciones Adicionales
Considerando que la intervención se realiza por equipos especializados experimentados y por protocolos definidos, los efectos indeseables graves son poco frecuentes.
Los efectos indeseables menos graves son los más frecuentes.
Evidencia de investigación
|
Coronariografía precoz versus manejo guiado por isquemia post-trombolisis en IAM con SDST. |
||||||
|
Población |
Personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) tratados con trombolíticos |
|||||
|
Intervención |
Coronariografía y eventual angioplastía de rutina precoz. |
|||||
|
Comparación |
Realizarla sólo en caso de presentar síntomas o isquemia. |
|||||
|
Desenlaces** |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
Realizarla sólo en caso de presentar síntomas o isquemia |
Coronariografía y angioplastía rutinaria precoz |
Diferencia (IC 95%) |
||||
|
Mortalidad |
RR 0,80 (0,59 a 1,08) — 6 ensayos [34, 36, 42, 45, 49, 59] / 2410 pacientes |
78 por 1000 |
62 por 1000 |
Diferencia: 16 menos (32 menos a 6 más) |
⊕⊕⊕◯1 Moderada |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia probablemente disminuye la mortalidad. |
|
Reinfarto |
RR 0,64 (0,46 a 0,90) — 6 ensayos [34, 36, 42, 45, 49, 59] / 2410 pacientes |
70 por 1000 |
45 por 1000 |
Diferencia: 25 menos (7 a 38 menos) |
⊕⊕⊕⊕ Alta |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia disminuye el riesgo de reinfarto. |
|
Accidente cerebrovascular |
RR 0,60 (0,27 a 1,33) — 2 ensayos [42, 49] / 463 pacientes |
68 por 1000 |
41 por 1000 |
Diferencia: 27 menos (50 menos a 22 más) |
⊕⊕◯◯2 Baja |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia podría disminuir los accidentes cerebrovasculares, pero la certeza de la evidencia es baja. |
|
Hospitalización |
RR 0,93 (0,70 a 1,24) — 1 ensayo [59] / 984 pacientes |
165 por 1000 |
153 por 1000 |
Diferencia: 12 menos (49 menos a 40 más) |
⊕⊕◯◯2 Baja |
Coronariografía y eventual angioplastía de rutina precoz comparado con realizarla sólo en caso de presentar síntomas o isquemia podría disminuir los accidentes cerebrovasculares, pero la certeza de la evidencia es baja. |
|
Insuficiencia cardiaca |
El desenlace insuficiencia cardiaca no fue reportado. |
— |
— |
|||
|
Hemorragia |
El desenlace hemorragia no fue reportado. |
— |
— |
|||
IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo CON realizarla sólo en caso de presentar síntomas o isquemia está basado en el riesgo del grupo control en los estudios. El riesgo CON coronariografía y angioplastía precoz (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
**Seguimiento promedio 1 año.
1 Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
2 Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión opuesta (intervalo de confianza muy amplio).
Fecha de elaboración de la tabla: Enero, 2019.
Referencia
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Moderada: Existe confianza respecto del efecto de «realizar coronariografía y eventual angioplastía de rutina precoz» en comparación a » realizarla sólo en caso de presentar síntomas o isquemia».
Evidencia de investigación
|
Desenlaces |
Importancia |
Certainty of the evidence |
|
Mortalidad |
CRÍTICO |
⨁⨁⨁◯ |
|
Reinfarto |
CRÍTICO |
⨁⨁⨁◯ |
|
Accidente cerebrovascular |
IMPORTANTE |
⨁⨁◯◯ |
|
Hospitalizaciones |
IMPORTANTE |
⨁⨁◯◯ |
a. Se disminuyó un nivel de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión diferente.
b. Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva una decisión opuestas (intervalo de confianza muy amplio).
| Incertidumbre o variabilidad importantes | Posiblemente hay incertidumbre o variabilidad importantes | Probablemente no hay incertidumbre ni variabilidad importantes | No hay variabilidad o incertidumbre importante |
|---|
No hay variabilidad o incertidumbre importante: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el equipo elaborador de la Guía consideró que no existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «realizar coronariografía y eventual angioplastía de rutina precoz» y » realizarla sólo en caso de presentar síntomas o isquemia». Todas o casi todas las personas escogerían realizar coronariografía y eventual angioplastía de rutina precoz.
Evidencia de investigación
No se encontraron estudios que respondieran la pregunta desde la perspectiva de valores y preferencias de pacientes o cuidadores.
Referencias
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | No lo sé |
|---|
Favorece la intervención: Considerando que la intervención es «realizar coronariografía y eventual angioplastía de rutina precoz» y la comparación es » realizarla sólo en caso de presentar síntomas o isquemia», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «realizar coronariografía y eventual angioplastía de rutina precoz».
| Costos extensos | Costos moderados | Costos y ahorros despreciables | Ahorros moderados | Ahorros extensos | Varía | No lo sé |
|---|
Costos extensos: El equipo elaborador de la Guía consideró que los costos de «realizar coronariografía y eventual angioplastía de rutina precoz» son grandes si se compara con los costos de » realizarla sólo en caso de presentar síntomas o isquemia», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Evidencia de investigación
|
Ítem |
Realizar coronariografía y eventual angioplastia precoz |
Realizar coronariografía y eventual angioplastia tardía** |
|
Coronariografía Cinecoronariografía (A.C. 17-01-019)
|
$ 57.5802
|
$ 57.5802
|
|
Cinecoronariografía electiva o de urgencia |
$ 446.5803 |
$ 446.5803 |
|
ANGIOPLASTÍA Procedimiento que Incluye día cama baja complejidad y UCI, exámenes de laboratorio y de imagen, insumos, stents, guías y balones
|
$ 2.315.8731
|
$ 2.315.8731
|
|
Trombolíticos: (Tenecteplase 50 mg 10 ml Jeringa prellenada) (30-50 mg según peso)
|
$ 517.216 4-$714.3575
|
$ 517.216 4-$714.3575
|
|
(Alteplase 50 mg) (Caja con 2 sets completos para el tratamiento fibrinolítico. Cada set contiene: 1 vial con 50 mg de alteplase + 1 vial con 50 cc de agua estéril para inyectables + 1 cánula de transferencia).
|
$ 1.046.5945
|
$ 1.046.5945
|
|
Estreptoquinasa 1,500,000 UI – am (1.500.000 UI en 30- 60 minutos)4 |
$ 63.4066
|
$ 63.4066
|
*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación(es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
** Podrían existir costos adicionales por realizar el procedimiento tardíamente.
Referencias
1. Precio estudio de costo FONASA
2. Arancel MLE, 2018.
3. PPV, 2018.
4. Canasta GES, 2017.
5. Mercado Público. Precio más IVA.
6. Precio obtenido de la base de datos del Estudio de Verificación de Costos 2015 MINSAL. El precio fue actualizado utilizando la UF al 1 de julio 2018.
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | Ningún estudio incluido |
|---|
Probablemente favorece la intervención: Considerando que la intervención es «realizar coronariografía y eventual angioplastía de rutina precoz» y la comparación es » realizarla sólo en caso de presentar síntomas o isquemia», el equipo elaborador de la Guía opinó que probablemente la alternativa más costo-efectiva es «realizar coronariografía y eventual angioplastía de rutina precoz».
Consideraciones Adicionales
El panel señala que en personas donde se realiza la intervención se disminuyen las coronografías de emergencia, las cuales son de mayor costo.
Al disminuir los reinfartos, se disminuyen todos los costos asociados a ello.
Evidencia de investigación
No se encontraron estudios de costo efectividad ni evaluaciones económicas que respondan esta pregunta.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de costo efectividad
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Reducida: El equipo elaborador de la Guía consideró que la equidad en salud se reduciría si se recomendase «realizar coronariografía y eventual angioplastía de rutina precoz», dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.
Consideraciones Adicionales
La intervención evaluada no esta financiada por la Ley 19.966, lo que genera desigualdad de acceso.
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar coronariografía y eventual angioplastía de rutina precoz» SÍ es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar coronariografía y eventual angioplastía de rutina precoz» SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.