A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- 1 Year Graft Patency Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age equal or more than 40
- •age equal or less than 75
- •patients who agree to the enrollment
排除标准
- •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
结局指标
主要结局
1 Year Graft Patency Rates
时间窗: one year
1 year graft patency of second limb conduits measured by 1 year coronary angiography
次要结局
- 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)
研究者
Ki-Bong Kim
Professor and Chairman, Department of Thoracic and Cardiovascular Surgery
Seoul National University Hospital