An interventional study of Skeletonized LIMA Harvesting and Non-Skeletonized LIMA Harvesting in Coronary Artery Disease, Coronary Artery Bypass Grafting and Surgical Site Infection, sponsored by Hamilton Health Sciences Corporation. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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.
Procedure: 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.
Procedure: Non-Skeletonized LIMA Harvesting
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 (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)
Number of Participants with Graft Patency
Binary assessment of LIMA-LAD graft patency versus graft failure
Time frame: 1.5 years after surgery
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
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation