Total Arterial vs. Mixed Grafting in Left Coronary CABG

NCT ID: NCT07057713

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Total Arterial Grafting

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional Mixed Grafting

Intervention Type: PROCEDURE

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.

Interventions

Total 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.

Intervention Type: PROCEDURE

Conventional 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.

Intervention Type: PROCEDURE

Other Intervention Names

LITA + Radial Artery Grafting; Mixed Arterial-Venous Grafting

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Kexiang Liu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kexiang Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery, The Second Hospital of Jilin University

Locations

The Second Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

kexiang liu

Role: CONTACT

kxliu64@hotmail.com

17390920328

Facility Contacts

kexiang liu, Ph.D.

Role: primary

Other Identifiers

JDEYXWK208

Identifier Type: -

Identifier Source: org_study_id