A Prospective Randomized Study for Comparison of Y-Composite Grafts
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: saphenous vein composite graftingProcedure: right internal thoracic artery composite grafting
- Registration Number
- NCT01051986
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- age equal or more than 40
- age equal or less than 75
- patients who agree to the enrollment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SVG group saphenous vein composite grafting patients who underwent off-pump coronary artery bypass using saphenous vein composite grafting based on the left internal thoracic artery use saphenous vein as a composite graft connected to the left internal thoracic artery RITA group right internal thoracic artery composite grafting patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite grafting based on the left internal thoracic artery use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
- Primary Outcome Measures
Name Time Method 1 Year Graft Patency Rates one year 1 year graft patency of second limb conduits measured by 1 year coronary angiography
- Secondary Outcome Measures
Name Time Method Overall Survival 4 years Overall survival rate at 4 years
Freedom From Cardiac Death 4 years Freedom rate from cardiac death at 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) 4 years freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Early Angiographic Patency Rates 1.4days The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
Trial Locations
- Locations (1)
Seoul National Uinversity Hospital
🇰🇷Seoul, Korea, Republic of