A Prospective, Randomized, Double-Blind Controlled Trial Comparing Total Arterial Grafting Versus Conventional Mixed Grafting in the Left Coronary Artery System During Coronary Artery Bypass Grafting (CABG)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Graft Patency Rate
研究概览
简要总结
This is a prospective, randomized, double-blind controlled trial comparing the clinical efficacy of total arterial grafting (internal thoracic artery and radial artery) versus conventional mixed grafting (internal thoracic artery and great saphenous vein) in the left coronary artery system during coronary artery bypass grafting (CABG). A total of 400 patients undergoing elective CABG at the Second Hospital of Jilin University will be enrolled and randomized into two groups. The primary endpoint is graft patency at 12 months postoperatively, evaluated by coronary angiography or CT angiography. Secondary outcomes include perioperative complications, major adverse cardiovascular events (MACE), and long-term clinical prognosis. The study aims to provide evidence-based guidance on optimal graft selection in CABG.
详细描述
Coronary artery bypass grafting (CABG) remains a cornerstone treatment for multivessel coronary artery disease. The choice of conduit significantly affects long-term graft patency and patient outcomes. While the left internal thoracic artery (LITA) to the left anterior descending artery (LAD) is standard, the optimal strategy for other coronary territories-such as the circumflex and right coronary arteries-remains debated.
This prospective, randomized, double-blind controlled trial aims to evaluate the long-term clinical efficacy of total arterial grafting (LITA + radial artery) versus conventional mixed grafting (LITA + great saphenous vein) in the left coronary artery system. A total of 400 patients scheduled for elective CABG at the Second Hospital of Jilin University will be enrolled and randomly assigned to one of the two surgical strategies. The experimental group will receive total arterial grafts to the LAD and circumflex branches, while the control group will receive arterial graft to LAD and vein grafts to the circumflex.
The primary endpoint is graft patency at 12 months post-surgery, assessed via coronary angiography or CT angiography. Secondary outcomes include major adverse cardiovascular events (MACE), perioperative complications (e.g., myocardial infarction, atrial fibrillation, infection), and long-term changes in cardiac function (e.g., LVEF, NYHA class). All surgeries will be performed by the same experienced surgical team following standardized procedures.
Patients will be followed at 1, 6, and 12 months postoperatively. Data will be collected through the hospital electronic medical record system and analyzed with appropriate statistical methods, including Cox proportional hazards modeling and Kaplan-Meier survival curves. Ethical approval has been obtained, and informed consent will be required from all participants. This study is designed to provide high-level evidence to optimize graft selection strategies in CABG.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to the grafting strategy. The surgical team will not be blinded due to the nature of the intervention, but outcome evaluation will be conducted by independent, blinded assessors.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosed with multivessel coronary artery disease
- •Indicated for elective coronary artery bypass grafting (CABG) involving ≥3 coronary vessels
- •Right coronary artery stenosis >75%
- •Able and willing to provide written informed consent
排除标准
- •Scheduled for concurrent cardiac procedures (e.g., valve surgery, congenital heart disease repair, aortic dissection surgery, atrial fibrillation ablation)
- •Severe stenosis of left or right subclavian artery
- •Unsuitable saphenous veins (e.g., bilateral varicosities)
- •Unsuitable radial artery as assessed preoperatively
- •History of intracranial hemorrhage or ischemic stroke within the past 14 days
- •Severe hepatic or renal insufficiency
- •Acute myocardial infarction within 72 hours prior to surgery
- •History of prior CABG or other cardiac surgery
研究组 & 干预措施
Total Arterial Grafting Group
Patients in this group will undergo coronary artery bypass grafting (CABG) with total arterial grafts to the left coronary artery system. The left internal thoracic artery (LITA) will be grafted to the left anterior descending artery (LAD), and the radial artery will be anastomosed to the obtuse marginal or diagonal branches of the circumflex artery. The right coronary artery, if revascularized, will receive a conventional vein graft.
干预措施: Total Arterial Grafting (Procedure)
Conventional Mixed Grafting Group
Patients in this group will receive conventional mixed grafting during CABG. The left internal thoracic artery (LITA) will be used for the LAD, while the great saphenous vein will be grafted to other branches of the left coronary artery system, such as the obtuse marginal or diagonal branches. The right coronary artery, if revascularized, will also be grafted using a vein.
干预措施: Conventional Mixed Grafting (Procedure)
结局指标
主要结局
Graft Patency Rate
时间窗: 12 months after surgery
Graft patency will be assessed at 12 months after surgery by coronary angiography or coronary CT angiography. A patent graft is defined as one with \<50% stenosis and continuous flow. The proportion of patients with all coronary artery grafts remaining patent will be calculated and compared between groups.
次要结局
- Incidence of Perioperative Complications(Within 30 days after surgery)
- Incidence of Major Adverse Cardiovascular Events(Within 12 months after surgery)
研究者
Kexiang Liu, MD
Principal Investigator
Second Hospital of Jilin University