COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1,116
- 主要终点
- Graft Patency
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, data collectors, research coordinators, outcome adjudicators, CTA core laboratory readers, and statisticians are blinded to treatment allocation. Only the operating surgeon and operating room staff are aware of the assigned harvesting technique. CTA images are de-identified prior to core laboratory review, and outcome adjudication is performed by blinded independent committees.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft
- •Provision of written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Skeletonized LIMA Harvesting (Procedure)
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.
干预措施: Non-Skeletonized LIMA Harvesting (Procedure)
结局指标
主要结局
Graft Patency
时间窗: 1.5 years after surgery
Binary assessment of LIMA-LAD graft patency versus graft failure
Number of Participants with Graft Patency
时间窗: 1.5 years after surgery
Binary assessment of LIMA-LAD graft patency versus graft failure
次要结局
- MACE(2 years after surgery)
- Sternal Surgical Site Infection(90 days after surgery)
- Sternal Chronic Postsurgical Pain(90 days after surgery)
- LIMA-LAD Driven Repeat Revascularization or Occlusion(2 years after surgery)
- Number of Participants with a Sternal Surgical Site Infection(90 days after surgery)
- Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion(2 years after surgery)