Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment (COMFORT)
COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The COMFORT trial is an international, multicentre, blinded, expertise-based randomized controlled trial evaluating two commonly used techniques for harvesting the left internal mammary artery (LIMA) during coronary artery bypass grafting (CABG): skeletonized and non-skeletonized (pedicled) harvesting.
Although skeletonized harvesting has been associated with reduced sternal wound complications and postoperative pain, concerns have emerged regarding its potential impact on graft patency and long-term cardiovascular outcomes. Existing evidence is largely derived from observational studies and post hoc analyses, and no adequately powered randomized trial has prospectively compared these techniques using systematic imaging-based graft assessment.
The COMFORT trial will enroll approximately 1,116 patients undergoing isolated CABG with a planned LIMA-to-LAD graft. Participants will be randomly assigned to undergo either skeletonized or non-skeletonized LIMA harvesting performed by surgeons experienced in both techniques. Participants and outcome assessors will remain blinded to treatment allocation.
Participants will undergo protocol-mandated coronary computed tomography angiography (CTA) at 1.5 years after surgery, with follow-up extending to 2 years. Independent blinded committees and a central CTA core laboratory will adjudicate imaging and clinical outcomes. In addition to graft assessment, the study will evaluate the effects of harvesting technique on cardiovascular outcomes, sternal wound complications, chronic postoperative pain, quality of life, and healthcare resource utilization.
The findings of COMFORT are expected to provide definitive evidence to guide surgical practice and inform future guidelines regarding the optimal method of internal mammary artery harvesting during CABG surgery.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft
- Provision of written informed consent
Exclusion Criteria:
- Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy)
- Emergency surgery (defined as surgery required within 24 hours of presentation)
- History of prior sternotomy
- Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery
- History of chronic sternal pain prior to the index surgery
- Known left subclavian artery stenosis (>50%)
- Previous radiation therapy to the chest
- Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² at baseline (relative contraindication to CTA contrast) as determined based on each centre's laboratory standard.
- Known pregnancy or plans for pregnancy during the study period
- Life expectancy less than 1.5 years due to non-cardiac conditions
- Inability or unwillingness to comply with follow-up procedures including CTA at 1.5 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Skeletonized LIMA Harvesting
Harvesting of the left internal mammary artery as a skeletonized conduit during CABG surgery, with removal of surrounding tissues while preserving the artery as an isolated graft conduit.
|
Skeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves
|
|
Comparador activo: Non-Skeletonized LIMA Harvesting
Conventional pedicled harvesting of the left internal mammary artery during CABG surgery, with preservation of the surrounding veins, fascia, and supporting tissues around the graft conduit.
|
Non-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants with Graft Patency
Periodo de tiempo: 1.5 years after surgery
|
Binary assessment of LIMA-LAD graft patency versus graft failure
|
1.5 years after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
MACE
Periodo de tiempo: 2 years after surgery
|
The composite of cardiovascular mortality, myocardial infarction, or repeat revascularization
|
2 years after surgery
|
|
Number of Participants with a Sternal Surgical Site Infection
Periodo de tiempo: 90 days after surgery
|
The composite of sternal surgical site infection
|
90 days after surgery
|
|
Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion
Periodo de tiempo: 2 years after surgery
|
Any coronary revascularization procedure (PCI or CABG) targeting the LIMA-LAD graft territory, or occlusion of the LIMA-LAD graft revealed by clinically indicated coronary angiography or CTA
|
2 years after surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andre Lamy, MD, Population Health Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Complicaciones Postoperatorias
- Procesos Patológicos
- Enfermedades cardíacas
- Infecciones
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Infección en la herida
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad de la arteria coronaria
- Infección de herida quirúrgica
Otros números de identificación del estudio
- COMFORT
Información sobre medicamentos y dispositivos, documentos del estudio
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