This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients will be enrolled and randomly assigned to two surgical method groups: RIMA-SVG Group (150 patients): SVGs are connected to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The aorta is clamped, and SVGs are connected to the ascending aorta (Ao).All patients will undergo CABG on a beating heart with sequential vein grafts to bypass at least two or more coronary vessels. The primary outcome is 1-year graft patency. The secondary outcomes include neurological complications, mortality, major adverse cardiovascular events (MACE), and surgical site infection event.
This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients undergoing CABG on a beating heart will be randomized into two surgical technique groups: RIMA-SV Group (150 patients): SVGs are anastomosed to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The ascending aorta is clamped, and SVGs are anastomosed to the aorta. All patients will undergo CABG via median sternotomy, and the left internal mammary artery (LIMA) will be used to bypass the left anterior descending artery (LAD). SVGs will be sequentially grafted to the circumflex artery, diagonal branch, and right coronary artery. The primary outcome is 1-year graft patency, assessed by coronary CT angiography and classified using the FitzGibbon grading system. Secondary outcomes include all-cause mortality, major adverse cardiovascular events (MACE), neurological complications, and surgical site infection event. Patients will be followed at 12 months for clinical evaluations and imaging assessments. Inclusion criteria include patients aged 18 to 80 years undergoing planned CABG with at least two sequential saphenous vein grafts and who are able to provide written informed consent. Exclusion criteria include additional cardiac surgeries, severe subclavian artery stenosis, unsuitable SVGs (e.g. bilateral varicosities), history of intracranial hemorrhage, active bleeding, malignancy, or emergency surgery. Randomization will be computer-generated, and all aspects of the study will remain blinded to ensure unbiased assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
the Second Hospital of Jilin University
Changchun, Jilin, China
1-Year Graft Patency
The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography
Time frame: 1 year post-surgery
Perioperative complications
Incidence of Perioperative complications related to CABG, including myocardial infarction, arrhythmias and other major adverse events.
Time frame: 2 weeks post-surgery
Neurological Complications
Incidence of neurological complications, including stroke within 1 year after CABG.
Time frame: 1 year post-surgery
All-Cause Mortality
Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, Incidence of death from any cause within 1 year after CABG.
Time frame: 1 year post-surgery
Major Adverse Cardiovascular Events (MACE)
Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, and target vessel revascularization, within 1 year after CABG.after CABG.
Time frame: 1 year post-surgery
Surgical site infection event
Incidence of surgical site infection event during hospitalization and within 1 year
Time frame: 1 year post-surgery
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