Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054847
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2003-02-11
Brief Title:
Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 474 - Radial Artery vs Saphenous Vein Grafts in Coronary Artery Bypass Surgery Radial Artery
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Primary Outcomes 1-year post CABG surgery patency rates
Study Abstract
Although the radial artery was introduced as a potential conduit for coronary artery bypass grafting in the 1970s enthusiasm for its use was limited by the technical difficulty of harvesting the vessel and problems with perioperative vascular spasm In spite of this some surgeons persisted based on their belief that arterial conduits would be better than vein grafts in terms of long-term patency With the development of new harvesting techniques and the introduction of calcium channel blockers to prevent vasospasm the use of the radial artery graft has increased in recent years This use of the radial artery as a conduit is not based on any long-term prospective data regarding its patency However because the VA has been a leader in defining the long-term efficacypatency of saphenous vein and internal mammary grafts it is appropriate for the VA to investigate radial artery grafts In fact the VA under its Cooperative Studies Program is probably the only health care delivery system that has the ability to undertake this study
Study Design
The study is a prospective randomized unblinded clinical trial The population consists of VA patients with coronary artery disease documented by coronary arteriography and who have agreed to undergo coronary artery bypass surgery Medical conditions which could affect blood flow through the patients arm are the main exclusion criteria These include Raynauds symptoms positive Allen test neurologic or musculoskeletal disease affecting the arm and patients with one arm
Patients who are eligible and agree to participate in the study will be randomly assigned to receive one radial artery graft or one saphenous vein graft to the following vessels left anterior descending if internal mammary not used circumflex diagonal and right coronary artery The surgeon will determine the subject vessel preoperatively by selecting the vessel that is suitable for grafting
The stratification factors will be the participating hospital and which vessel is to be bypassed left anterior descending versus all other vessels
History physical examination laboratory tests and cardiac catheterization will be performed at baseline and at one year Follow-up clinic visits will be at two weeks three six and nine months post CABG Coronary angiography will be performed one week and one year post surgery Quality of life and handleg functional status will be assessed at baseline three months and one year Cost measures will be captured
Biostatistical Considerations
For this trial a sample size of 874 randomized patients will be required This will provide 90 power to detect a difference in one-year patency rates of 92 for the radial artery versus 83 for the saphenous vein and an expected one-year catheter completion rate of 65
This is a five year study There will be four years of patient accrual and one year of follow-up Nine participating VA medical centers will be expected to randomize two patients per month
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
Primary Outcomes 1-year post CABG surgery patency rates
Study Abstract
Although the radial artery was introduced as a potential conduit for coronary artery bypass grafting in the 1970s enthusiasm for its use was limited by the technical difficulty of harvesting the vessel and problems with perioperative vascular spasm In spite of this some surgeons persisted based on their belief that arterial conduits would be better than vein grafts in terms of long-term patency With the development of new harvesting techniques and the introduction of calcium channel blockers to prevent vasospasm the use of the radial artery graft has increased in recent years This use of the radial artery as a conduit is not based on any long-term prospective data regarding its patency However because the VA has been a leader in defining the long-term efficacypatency of saphenous vein and internal mammary grafts it is appropriate for the VA to investigate radial artery grafts In fact the VA under its Cooperative Studies Program is probably the only health care delivery system that has the ability to undertake this study
Study Design
The study is a prospective randomized unblinded clinical trial The population consists of VA patients with coronary artery disease documented by coronary arteriography and who have agreed to undergo coronary artery bypass surgery Medical conditions which could affect blood flow through the patients arm are the main exclusion criteria These include Raynauds symptoms positive Allen test neurologic or musculoskeletal disease affecting the arm and patients with one arm
Patients who are eligible and agree to participate in the study will be randomly assigned to receive one radial artery graft or one saphenous vein graft to the following vessels left anterior descending if internal mammary not used circumflex diagonal and right coronary artery The surgeon will determine the subject vessel preoperatively by selecting the vessel that is suitable for grafting
The stratification factors will be the participating hospital and which vessel is to be bypassed left anterior descending versus all other vessels
History physical examination laboratory tests and cardiac catheterization will be performed at baseline and at one year Follow-up clinic visits will be at two weeks three six and nine months post CABG Coronary angiography will be performed one week and one year post surgery Quality of life and handleg functional status will be assessed at baseline three months and one year Cost measures will be captured
Biostatistical Considerations
For this trial a sample size of 874 randomized patients will be required This will provide 90 power to detect a difference in one-year patency rates of 92 for the radial artery versus 83 for the saphenous vein and an expected one-year catheter completion rate of 65
This is a five year study There will be four years of patient accrual and one year of follow-up Nine participating VA medical centers will be expected to randomize two patients per month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None