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Resúmenes Epistemonikos
Medwave 2017; 17(Suppl1):e6834 doi: 10.5867/medwave.2017.6834
¿Son beneficiosas las estatinas en el periodo perioperatorio de una cirugía cardiaca?
Are perioperative statins beneficial for cardiac surgery?
Gonzalo A Bravo-Soto, Valentina Llovet-Gutiérrez, Gabriel Rada
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Resumen

Se ha propuesto el uso de estatinas perioperatorias como una medida para disminuir la morbimortalidad en cirugía cardiaca. No obstante, su impacto clínico es controvertido. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos, identificamos 36 revisiones sistemáticas que en conjunto incluyen 92 estudios primarios de los cuales 22 son estudios aleatorizados. Realizamos un metanálisis y tablas de resumen de los resultados utilizando el método GRADE. Concluimos que las estatinas perioperatorias probablemente no disminuyen la mortalidad en cirugía cardiaca y no está claro si tienen algún beneficio porque la certeza de la evidencia es muy baja.


 
Problema

La cirugía cardiaca conlleva una alta morbimortalidad debido a múltiples causas tales como fibrilación auricular, infarto al miocardio, insuficiencia renal aguda, accidente vascular encefálico, entre otros. Por otra parte, las estatinas son una familia de medicamentos que ha demostrado disminución de eventos cardiovasculares, principalmente debido a su efecto clínico en el perfil lipídico. Sin embargo, se ha propuesto un efecto pleiotrópico, incluyendo un mecanismo antiinflamatorio agudo, cuyo real impacto clínico es controvertido.

En este contexto, se ha planteado que el uso de estatinas perioperatorias podría disminuir la morbimortalidad en cirugía cardiaca.

Métodos

Utilizamos la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en múltiples bases de datos, para identificar revisiones sistemáticas y sus estudios primarios incluidos. Con esta información generamos un resumen estructurado, siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metanálisis del total de los estudios, tablas de resumen de resultados con el método GRADE, y tabla de otras consideraciones para la toma de decisión.

Mensajes clave

  • Las estatinas perioperatorias probablemente no disminuyen la mortalidad en cirugía cardiaca.
  • No está claro si las estatinas perioperatorias tienen algún beneficio porque la certeza de la evidencia en relación al riesgo de fibrilación auricular, infarto agudo al miocardio e insuficiencia renal aguda es muy baja.
  • Si bien existe un altísimo número de revisiones sistemáticas en este tema, todas adolecen de limitaciones importantes o están desactualizadas.
Acerca del conjunto de evidencia para esta pregunta

Cuál es la evidencia. 
Véase matriz de evidencia en Epistemonikos más abajo.

Encontramos 36 revisiones sistemáticas reportadas en 38 referencias [1],[2],[3],[4],[5],[6],[7],[8],[9],[10],[11],
[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],
[23],[24],[25],[26],[27],[28],[29],[30],[31],[32],[33],
[34],[35],[36],[37],[38] que incluyen 92 estudios primarios reportados en 98 referencias [39],[40],[41],
[42],[43],[44],[45],[46],[47],[48],[49],[50],[51],[52], [53],[54],[55],[56],[57],[58],[59],[60],[61],[62],[63], [64],[65],[66],[67],[68],[69],[70],[71],[72],[73],[74], [75],[76],[77],[78],[79],[80],[81],[82],[83],[84],[85], [86],[87],[88],[89],[90],[91],[92],[93],[94],[95],[96],
[97],[98],[99],[100],[101],[102],[103],[104],[105],
[106],[107],[108],[109],[110],[111],[112],[112],[113], [114],[115],[116],[117],[118],[119],[120],[121],[122], [123],[124],[125],[126],[127],[128],[129],[130],[131], [132],[133],[134],[135],[136],[137]. Entre estos hay 22 estudios controlados aleatorizados, reportados en 28 referencias [42],[44],[45],[49],[50],[51],[56],[57],[58], [59],[60],[61],[62],[70],[78],[84],[93],[97],[107], [110],[111],[116],[117],[120],[121],[124],[125],[134]. La tabla y el resumen en general se basan en estos últimos.

Qué tipo de pacientes incluyeron los estudios

Las características de los pacientes incluidos fueron:

Respecto al tipo de cirugía, 17 estudios [45],[50],[51],[56], [57],[58],[59],[60],[78],[93],[97],[116],[117],[120],
[121],[124],[134] incluyeron sólo cirugía de reperfusión coronaria, cuatro cualquier tipo de cirugía cardiaca [70],[84], [107],[111] y uno cualquier tipo de cirugía cardiaca excepto cirugías coronarias [42].

Siete estudios excluían cirugía de urgencia [42],[59],[107], [111],[117],[121],[124] y un estudio [60] incluyó 87% de cirugías electivas.

Del resto de estudios aleatorizados controlados no se pudieron obtener datos desde las revisiones sistemáticas sobre esta variable.

Qué tipo de intervenciones incluyeron los estudios

Respecto al tipo de estatina utilizada, tres estudios [42], [60],[124] utilizaron simvastatina, 15 estudios utilizaron atorvastatina [45],[50],[58],[59],[70],[78],[84],[97], [107],[111],[116],[117],[120],[121],[134], dos estudios utilizaron rosuvastatina [57],[93], un estudio utilizó fluvastatina [51] y un estudio utilizó pravastatina/pitavastatina [56].

La dosis utilizada varió entre 20 a 80 mg al día dependiendo del tipo de estatina.

Todos los estudios compararon contra placebo o tratamiento estándar, excepto dos estudios [84],[116] que compararon contra dosis menores de estatinas.

Qué tipo de desenlaces midieron

Las revisiones sistemáticas agruparon los desenlaces de la siguiente manera:

  • Fibrilación auricular
  • Arritmias
  • Infarto agudo al miocardio
  • Accidente vascular encefálico
  • Insuficiencia renal aguda
  • Necesidad de terapia de reemplazo renal
  • Tiempo de hospitalización
  • Tiempo en unidad de cuidados intensivos
  • Necesidad de reintervención quirúrgica
  • Costo
  • Infecciones
Resumen de los resultados

La información sobre los efectos de las estatinas perioperatorias en cirugía cardiaca está basada en 22 estudios aleatorizados que incluyen 4335 pacientes.

Ocho estudios midieron mortalidad (735 pacientes) [50],[59],[60],[78],[107],[116],[117],[124], 12 estudios midieron fibrilación auricular (3020 pacientes) [50],[56],[57],[59],[78],[93],[107],[116],[117],[120],[124],[134], 11 midieron infarto agudo al miocardio (1064 pacientes) [50],[51],[59],[60],[70],[78],[93], [107],[116],[120],[134] y dos midieron insuficiencia renal aguda (117 pacientes) [57],[60].

El resumen de los resultados es el siguiente:

  • Las estatinas perioperatorias probablemente no disminuyen la mortalidad en cirugía cardiaca. La certeza de la evidencia es moderada.
  • No está claro si las estatinas perioperatorias disminuyen el riesgo de fibrilación auricular en cirugía cardiaca, porque la certeza de la evidencia es muy baja.
  • No está claro si las estatinas perioperatorias disminuyen el riesgo de infarto agudo al miocardio en cirugía cardiaca, porque la certeza de la evidencia es muy baja.
  • No está claro si las estatinas perioperatorias disminuyen el riesgo de insuficiencia renal aguda en cirugía cardiaca, porque la certeza de la evidencia es muy baja.

Otras consideraciones para la toma de decisión

A quién se aplica y a quién no se aplica esta evidencia

  • La evidencia presentada en este resumen se aplica a pacientes con cirugía cardiaca, tanto de revascularización coronaria como valvuloplastía.
  • El presente resumen no incluye cirugías cardiacas mediante cateterismo o cirugías vasculares, ya sea por vía abierta o endovascular.
Sobre los desenlaces incluidos en este resumen
  • Se escogieron los desenlaces de mortalidad, fibrilación auricular, infarto agudo al miocardio e insuficiencia renal aguda en este resumen, ya que son los desenlaces críticos para la toma de decisión sobre el uso de estatinas perioperatorias. Esta selección se basa en la opinión de los autores del resumen, pero en general coincide con los desenlaces mencionados por las revisiones sistemáticas y se sustenta en las causas de complicaciones más frecuentes en cirugías cardiacas.
Balance riesgo/beneficio y certeza de la evidencia
  • Se trata de una intervención que probablemente no impacta en la mortalidad, y cuyos beneficios son inciertos.
  • Es motivo de alarma que el mayor estudio existente haya mostrado un aumento en el riesgo de falla renal aguda [57].
  • No es posible realizar un adecuado balance entre beneficios y riesgos debido al bajo nivel de certeza existente.
Qué piensan los pacientes y sus tratantes
  • En base a la evidencia existente la mayoría de los clínicos debería inclinarse en contra de la utilización de estatinas en este contexto.
  • Sin embargo, debido a la baja tasa de efectos adversos y a la falta de recomendaciones claras al respecto, es probable que algunos clínicos que pongan mayor valor en un beneficio no probado, sigan utilizándolas.
Consideraciones de recursos
  • Las estatinas actualmente son un medicamento de bajo costo y fácil de administrar, por lo que este factor no debería condicionar la toma de decisión.
Diferencias entre este resumen y otras fuentes
  • La mayoría de las revisiones sistemáticas identificadas apoyan el uso de estatinas e intentan apoyar su teoría con una diversa lista de desenlaces, no siempre con un sustento fisiopatológico claro que respalde la conexión entre las estatinas y los desenlaces medidos.
  • Cabe destacar que el estudio aleatorizado más grande [57] evidencia un nulo efecto sobre fibrilación auricular (el principal desenlace en el cual se fundamenta el uso de estatinas en cirugía cardiaca según la mayoría de los investigadores). Además, destaca que sólo una revisión sistemática [7] incluye este estudio. Los resultados negativos de este estudio hacen pensar que en buena medida los beneficios atribuidos a las estatinas en cirugía cardiaca pueden deberse a sesgo de publicación. El funnel plot sugiere fuertemente una falta de estudios pequeños de reporte neutro/negativo.
  • Las conclusiones de este resumen no concuerdan con la guía de ACCF/AHA guideline for coronary artery bypass graft surgery [137], en donde se recomienda su uso rutinario en cirugía cardiaca. 
¿Puede que cambie esta información en el futuro?
  • La probabilidad de que futura investigación cambie las conclusiones de este resumen es muy alta para algunos desenlaces, debido a la muy baja certeza de la evidencia existente.
  • Existen al menos ocho estudios en curso (siete estudios aleatorizados controlados [138],[139],[140],[141],[142], [143],[144] y uno observacional [145]) en el International Clinical Trials Registry Platform de la Organización Mundial de la Salud que evalúan el uso de estatinas perioperatorias en cirugía cardiaca. Existe la probabilidad que estos estudios aclaren el real impacto clínico de las estatinas perioperatorias.
  • Si bien existe un número inusualmente alto de revisiones sistemáticas en esta área, se necesita una revisión actualizada, y que incorpore un análisis riguroso de los posibles factores que podrían explicar las discrepancias entre los estudios. Existe una revisión Cochrane en curso, que podría jugar este rol [146].
Cómo realizamos este resumen

Mediante métodos automatizados y colaborativos recopilamos toda la evidencia relevante para la pregunta de interés y la presentamos en una matriz de evidencia.

Siga el enlace para acceder a la versión interactiva: Estatinas perioperatorias para la cirugía cardiaca

Notas

Si con posterioridad a la publicación de este resumen se publican nuevas revisiones sistemáticas sobre este tema, en la parte superior de la matriz se mostrará un aviso de “nueva evidencia”.  Si bien el proyecto contempla la actualización periódica de estos resúmenes, los usuarios están invitados a comentar en Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más rápida.

Luego de crear una cuenta en Epistemonikos, al guardar las matrices recibirá notificaciones automáticas cada vez que exista nueva evidencia que potencialmente responda a esta pregunta. El detalle de los métodos para elaborar este resumen están descritos aquí: http://dx.doi.org/10.5867/medwave.2014.06.5997.

La Fundación Epistemonikos es una organización que busca acercar la información a quienes toman decisiones en salud, mediante el uso de tecnologías. Su principal desarrollo es la base de datos Epistemonikos (www.epistemonikos.org).

Los resúmenes de evidencia siguen un riguroso proceso de revisión por pares interno.

Declaración de conflictos de intereses
Los autores declaran no tener conflictos de intereses con la materia de este artículo.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

The use of perioperative statins has been proposed as a measure to reduce morbidity and mortality in cardiac surgery. However, their clinical role is controversial. Searching in Epistemonikos database, which is maintained by screening multiple databases, we identified 36 systematic reviews comprising 92 primary studies addressing the question of this article, including 22 randomized trials. We extracted data, combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded perioperative statins probably do not decrease mortality in cardiac surgery and it is unclear if they have any benefit because the certainty of the evidence is very low.

Autores: Gonzalo A Bravo-Soto[1,2], Valentina Llovet-Gutiérrez[1,2], Gabriel Rada[2,3,4,5,6]

Filiación:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[2] Proyecto Epistemonikos, Santiago, Chile
[3] Departamento de Medicina Interna, Facultad de Medicina, Pontificia Universidad Católica de Chile
[4] Programa de Salud Basada en Evidencia, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[5] GRADE working group
[6] The Cochrane Collaboration

E-mail: radagabriel@gmail.com

Correspondencia a:
[1] Facultad de Medicina
Pontificia Universidad Católica de Chile
Lira 63
Santiago Centro
Chile

Citación: Bravo-Soto GA, Llovet-Gutiérrez V, Rada G. Are perioperative statins beneficial for cardiac surgery?. Medwave 2017; 17(Suppl1):e6834 doi: 10.5867/medwave.2017.6834

Fecha de publicación: 16/1/2017

Ficha PubMed

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Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes. NCT02850081 | Link |

Efficacy of Different Perioperative Statin Regimens on the Protection Against Post Coronary Artery Bypass Grafting Major Adverse Cardio-cerebral Events. NCT02706860 | Link |

Statin Therapy to Limit Cognitive Dysfunction After Cardiac Surgery. NCT01186289 | Link |

The POSITIVE (Pre-Operative STatin InterVEntion) study, preoperative statin intervention for valve surgery. NTR2673 | Link |

The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study. NCT01909739 | Link |

Statin therapy in Ischemia-Reperfusion Injury: A randomised trial to evaluate the effect of high dose rosuvastatin on myocardial infarct size post coronary artery bypass grafting (CABG). ACTRN12613000031763 | Link |

Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF). NCT02029534 | Link |

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