Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery (RAPS - 5 years)
|Coronary Artery Disease||Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery|
- 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 ]
|Study Start Date:||July 2002|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: 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).
Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187356
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Manitoba Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|London Health Sciences Centre - UC|
|London, Ontario, Canada, N6A 5A5|
|London Health Sciences Centre - VC|
|London, Ontario, Canada, N6B1B1|
|Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Sunnybrook and Women's College HSC|
|Toronto, Ontario, Canada, M4N3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B1W8|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G2C4|
|Vancouver General Hospital|
|Vancouver, Ontario, Canada, V5Z1C6|
|Laval, Quebec, Canada, G1V4G5|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Montreal Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Hamilton, New Zealand|
|Study Chair:||Stephen E Fremes, MD||Sunnybrook Health Sciences Centre|