A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seoul National University Hospital
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- 1 Year Graft Patency Rates
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.
Detailed Description
The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.
Investigators
Ki-Bong Kim
Professor and Chairman, Department of Thoracic and Cardiovascular Surgery
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •age equal or more than 40
- •age equal or less than 75
- •patients who agree to the enrollment
Exclusion Criteria
- •Patients with heart failure (left ventricular ejection fraction \< 25%)
- •patients who have intractable ventricular arrhythmia
- •patients who has been treated for cancer
- •patients who has infectious disease
- •patients who are planned to undergo combined cardiac surgery
- •patients who has medical co-morbidity with expected survival less than 1 year
- •patients who has a problem using right internal thoracic artery or saphenous vein
- •patients with a history of previous cardiac surgery
- •Patients with chronic renal failure
- •patients who undergo emergency operation
Outcomes
Primary Outcomes
1 Year Graft Patency Rates
Time Frame: one year
1 year graft patency of second limb conduits measured by 1 year coronary angiography
Secondary Outcomes
- Overall Survival(4 years)
- Freedom From Cardiac Death(4 years)
- Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)(4 years)
- Early Angiographic Patency Rates(1.4days)