Total Arterial vs. Mixed Grafting in Left Coronary CABG

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Coronary Artery Bypass Grafting; Arterial Graft; Graft Patency; Major Adverse Cardiovascular Events

• Registration Number: NCT07057713
• Lead Sponsor: Second Hospital of Jilin University

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.

Study Timeline

• Study First Submitted: 2025-06-29
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China