A Randomised Controlled Trial to Compare Angiographic Patency of Radial Artery Versus Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularization
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Arteriosclerosis
- Sponsor
- Imperial College London
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Patency Rates
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.
Detailed Description
Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term. The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.
Investigators
Eligibility Criteria
Inclusion Criteria
- •on waiting list for clinically-indicated myocardial revascularization surgery
- •aged 40-70 years
- •significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms
- •negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression)
- •willing to give written informed consent
Exclusion Criteria
- •poor left ventricular (LV) function (LV ejection fraction \<25%)
- •severe diffuse peripheral vascular disease or bilateral varicose venous disease
- •inability to comply with the angiographic follow-up at 3 months or/and 5 years
Outcomes
Primary Outcomes
Patency Rates
Time Frame: 5 years
Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)
Time Frame: 5 year follow-up
Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.
Secondary Outcomes
- Blood Flow Volume(5 years)