CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 733
- 试验地点
- 22
- 主要终点
- To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.
研究概览
简要总结
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.
详细描述
Primary Hypothesis:
Radial artery grafts will have a higher graft patency rate at one year after coronary artery bypass graft surgery (CABG) compared to saphenous vein grafts.
Secondary Hypotheses:
Determine if there are any differences in clinical outcomes, cost and quality of life in patients receiving radial artery versus saphenous vein grafts.
Intervention: 1) Saphenous vein graft. This is the standard conduit for coronary artery bypass grafting to all areas of the heart except the left anterior descending (LAD) artery. 2) Radial artery. This is the experimental conduit. Preference should be given to harvesting from the non-dominant arm.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients needing coronary artery bypass grafts.
排除标准
- •Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
- •Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
- •Patients with Raynaud's symptoms
- •Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
- •Patients with a positive Allen test
- •Patients with cardiogenic shock
- •Patients who are unable to give consent
- •Patients allergic to contrast material
- •Patients undergoing repeat CABG or any form of robotic surgery
- •Patients who do not have full use of both arms
- •Patients who are pregnant
- •Patients with neurologic or musculoskeletal disease affecting the arm
- •Patients who refuse to participate
- •Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.
- •Patient requires concomitant Dor or Maze procedure
- •Patient is in another research study
- •No suitable radial target (there is no non-LAD vessel with a >70% stenosis)
结局指标
主要结局
To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.
时间窗: 1 year
The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.
次要结局
- Death(Within 1 year of surgery.)
- Myocardial Infarction(Within 1 year of bypass surgery)
- Stroke(Within 1 year of bypass surgery)