Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment

N/AWithdrawnNCT07720661

Hamilton Health Sciences Corporation

Overview

The COMFORT Trial is a randomized controlled superiority trial comparing skeletonized (SK) versus non-skeletonized (non-SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft in patients undergoing isolated coronary artery bypass grafting (CABG).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Coronary Artery Disease Coronary Artery Bypass Grafting Surgical Site Infection

Interventions

Skeletonized LIMA HarvestingPROCEDURE

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

Non-Skeletonized LIMA HarvestingPROCEDURE

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years or older 2. Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft 3. Provision of written informed consent Exclusion Criteria: 1. Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy) 2. Emergency surgery (defined as surgery required within 24 hours of presentation) 3. History of prior sternotomy 4. Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery 5. History of chronic sternal pain prior to the index surgery 6. Known left subclavian artery stenosis (\>50%) 7. Previous radiation therapy to the chest 8. Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication 9. 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. 10. Known pregnancy or plans for pregnancy during the study period 11. Life expectancy less than 1.5 years due to non-cardiac conditions 12. Inability or unwillingness to comply with follow-up procedures including CTA at 1.5 years

Outcomes

Primary Outcomes

Number of Participants with Graft Patency

Binary assessment of LIMA-LAD graft patency versus graft failure

Time frame: 1.5 years after surgery

Secondary Outcomes

MACE

The composite of cardiovascular mortality, myocardial infarction, or repeat revascularization

Time frame: 2 years after surgery

Number of Participants with a Sternal Surgical Site Infection

The composite of sternal surgical site infection

Time frame: 90 days after surgery

Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion

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

Time frame: 2 years after surgery

Data from ClinicalTrials.gov

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