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.
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 1. The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.
University of Alberta
Edmonton, Alberta, Canada
Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada
London Health Sciences Centre - UC
London, Ontario, Canada
London Health Sciences Centre - VC
London, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook and Women's College HSC
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Vancouver General Hospital
Vancouver, Ontario, Canada
Laval Hospital
Laval, Quebec, Canada
...and 3 more locations
The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).
Time frame: Beyond 5 years after bypass urgery
a) the proportion of occluded study grafts (TIMI 0)
Time frame: Beyond 5 years after bypass urgery
b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Time frame: Beyond 5 years after bypass urgery
c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Time frame: Beyond 5 years after bypass urgery
d) proportion of study grafts with string sign
Time frame: Beyond 5 years after bypass urgery
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