Arterial Graft, Coronary Artery Bypass Grafting, Coronary Artery Disease, Graft Patency, Major Adverse Cardiovascular Events
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETotal Arterial Grafting
Coronary artery bypass grafting using only arterial conduits in the left coronary artery system. The left internal thoracic artery (LITA) is grafted to the LAD, and the radial artery is anastomosed to the obtuse marginal or diagonal branches. This approach avoids the use of saphenous vein grafts for the left coronary system.
PROCEDUREConventional Mixed Grafting
A standard coronary artery bypass grafting (CABG) procedure where the left internal thoracic artery (LITA) is grafted to the LAD, and saphenous vein grafts are used for the obtuse marginal or diagonal branches of the left coronary system. This approach represents the conventional mixed arterial-venous strategy.
Sponsors
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Patients undergoing elective CABG will be randomized 1:1 to receive either total arterial grafting or conventional mixed grafting in the left coronary system.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Diagnosed with multivessel coronary artery disease 3. Indicated for elective coronary artery bypass grafting (CABG) involving ≥3 coronary vessels 4. Right coronary artery stenosis \>75% 5. Able and willing to provide written informed consent
Exclusion criteria
1. Scheduled for concurrent cardiac procedures (e.g., valve surgery, congenital heart disease repair, aortic dissection surgery, atrial fibrillation ablation) 2. Severe stenosis of left or right subclavian artery 3. Unsuitable saphenous veins (e.g., bilateral varicosities) 4. Unsuitable radial artery as assessed preoperatively 5. History of intracranial hemorrhage or ischemic stroke within the past 14 days 6. Severe hepatic or renal insufficiency 7. Acute myocardial infarction within 72 hours prior to surgery 8. History of prior CABG or other cardiac surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Patency Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events | Within 12 months after surgery | MACE includes cardiac death, nonfatal myocardial infarction, and the need for repeat revascularization. Events will be recorded during hospitalization and follow-up visits up to 12 months after surgery. |
| Incidence of Perioperative Complications | Within 30 days after surgery | Includes postoperative atrial fibrillation, stroke, wound infection, renal insufficiency, and reoperation for bleeding. Data will be collected during hospitalization. |
Countries
China
Contacts
CONTACTkexiang liu
PRINCIPAL_INVESTIGATORKexiang Liu
Department of Cardiovascular Surgery, The Second Hospital of Jilin University
Outcome results
None listed