Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 13
- 主要终点
- The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).
研究概览
简要总结
Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial arteries were more likely to be functioning than saphenous veins. We hypothesize that radial arteries will continue to be superior beyond 5 years.
详细描述
The multi-centre Radial Artery Patency Study, (RAPS) is a series of longitudinal graft patency studies designed to compare the long-term patency of the radial artery to the saphenous vein. Between 1996 and 2001, 561 patients were intraoperatively randomized to undergo surgery according to one of two strategies: radial-artery grafting to the circumflex territory and saphenous-vein grafting to the right coronary artery or radial-artery grafting to the right coronary artery and saphenous-vein grafting to the circumflex territory. The first study compared the 8-12 month angiographic patency of the radial artery with that of the saphenous vein as a conduit for coronary artery bypass and found that radial arteries were superior. The primary objective of this current study is to determine the beyond 5-year angiographic patency of the radial artery compared with a saphenous vein coronary bypass graft.
HYPOTHESES
- The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts.
- Radial artery conduits studied beyond 5 years postoperatively have less graft disease than saphenous veins.
SAMPLE SIZE We expect to study 350 patients, which will allow us to test for a 35% risk reduction from 23% occlusion rate in saphenous veins to 15% in radial arteries, assuming a 5% within-patient correlation, with 80% power for a 2-tailed alpha of 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January
- •These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.
排除标准
- •Exclusion criteria included 1: Inability to use the radial artery or saphenous vein conduits: a)nonpalpable ulnar arteries or a positive Allen's test, b) an abnormal Doppler study or ultrasonographic study of the arms, c) a history of vasculitis or Raynaud's syndrome, bilateral varicose veins or vein stripping. 2: Conditions that affected the safety of follow-up angiography: a)renal insufficiency (creatinine > 180 umol/L) b)severe peripheral vascular disease precluding femoral access b)coagulopathy or obligatory uninterrupted use of anticoagulants c) known allergy to radiographic contrast media d) women of childbearing potential e) comorbid illness which precludes the use of follow up angiography f) geographically inaccessible for follow up angiography.
研究组 & 干预措施
Surgical Conduit
The surgical arm will be composed of the experimental arm (the use of the radial artery) versus an active comparator (the use of the saphenous vein graft).
干预措施: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories (Procedure)
结局指标
主要结局
The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).
时间窗: Beyond 5 years after bypass urgery
次要结局
- a) the proportion of occluded study grafts (TIMI 0)(Beyond 5 years after bypass urgery)
- b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%(Beyond 5 years after bypass urgery)
- c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%(Beyond 5 years after bypass urgery)
- d) proportion of study grafts with string sign(Beyond 5 years after bypass urgery)
研究者
Stephen E. Fremes
Head, Division of Cardiac and Vascular Surgery and Dr. Bernard S. Goldman Chair in Cardiovascular Surgery
Sunnybrook Health Sciences Centre