Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery - Full Text View

Purpose

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.

Condition	Intervention
Cardiovascular Disease Coronary Artery Disease	Procedure: saphenous vein graft Procedure: radial artery graft


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.

Secondary Outcome Measures:

Death [ Time Frame: Within 1 year of surgery. ] [ Designated as safety issue: No ]
Myocardial Infarction [ Time Frame: Within 1 year of bypass surgery ] [ Designated as safety issue: No ]
Stroke [ Time Frame: Within 1 year of bypass surgery ] [ Designated as safety issue: No ]


Enrollment:	733
Study Start Date:	February 2003
Study Completion Date:	February 2010
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Saphenous Vein Graft Saphenous Vein Graft	Procedure: saphenous vein graft Saphenous vein harvested from the arm is used as a conduit for CABG.
Active Comparator: Radial Artery Graft Radial Artery Graft	Procedure: radial artery graft Radial artery harvested from the arm is used as a conduit for CABG.

Show Detailed Description

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients needing coronary artery bypass grafts.

Exclusion Criteria:

Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
Patients with Raynaud's symptoms
Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
Patients with a positive Allen test
Patients with cardiogenic shock
Patients who are unable to give consent
Patients allergic to contrast material
Patients undergoing repeat CABG or any form of robotic surgery
Patients who do not have full use of both arms
Patients who are pregnant
Patients with neurologic or musculoskeletal disease affecting the arm
Patients who refuse to participate
Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.
Patient requires concomitant Dor or Maze procedure
Patient is in another research study
No suitable radial target (there is no non-LAD vessel with a >70% stenosis)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054847

Locations


United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Study Chair:	Steven Goldman, MD	Southern Arizona VA Health Care System

More Information

Publications:

Mudumbai SC, Wagner T, Mahajan S, King R, Heidenreich PA, Hlatky M, Wallace A, Mariano ER. Vascular surgery patients prescribed preoperative β-blockers experienced a decrease in the maximal heart rate observed during induction of general anesthesia. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):414-9. doi: 10.1053/j.jvca.2011.09.027. Epub 2011 Dec 3.

Sinnott PL, Siroka AM, Shane AC, Trafton JA, Wagner TH. Identifying neck and back pain in administrative data: defining the right cohort. Spine (Phila Pa 1976). 2012 May 1;37(10):860-74. doi: 10.1097/BRS.0b013e3182376508. Review.

Yoon J, Scott JY, Phibbs CS, Wagner TH. Recent trends in Veterans Affairs chronic condition spending. Popul Health Manag. 2011 Dec;14(6):293-8. doi: 10.1089/pop.2010.0079. Epub 2011 Nov 1.

McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13.

Bakaeen FG, Sethi G, Wagner TH, Kelly R, Lee K, Upadhyay A, Thai H, Juneman E, Goldman S, Holman WL. Coronary artery bypass graft patency: residents versus attending surgeons. Ann Thorac Surg. 2012 Aug;94(2):482-8; discussion 488. doi: 10.1016/j.athoracsur.2012.04.039. Epub 2012 Jun 13.

Goldman S, Sethi GK, Holman W, Thai H, McFalls E, Ward HB, Kelly RF, Rhenman B, Tobler GH, Bakaeen FG, Huh J, Soltero E, Moursi M, Haime M, Crittenden M, Kasirajan V, Ratliff M, Pett S, Irimpen A, Gunnar W, Thomas D, Fremes S, Moritz T, Reda D, Harrison L, Wagner TH, Wang Y, Planting L, Miller M, Rodriguez Y, Juneman E, Morrison D, Pierce MK, Kreamer S, Shih MC, Lee K. Radial artery grafts vs saphenous vein grafts in coronary artery bypass surgery: a randomized trial. JAMA. 2011 Jan 12;305(2):167-74. doi: 10.1001/jama.2010.1976.

Wagner TH, Holman W, Lee K, Sethi G, Ananth L, Thai H, Goldman S. The generalizability of participants in Veterans Affairs Cooperative Studies Program 474, a multi-site randomized cardiac bypass surgery trial. Contemp Clin Trials. 2011 Mar;32(2):260-6. doi: 10.1016/j.cct.2010.11.008. Epub 2010 Nov 13.

Humphreys K, Wagner TH, Gage M. If substance use disorder treatment more than offsets its costs, why don't more medical centers want to provide it? A budget impact analysis in the Veterans Health Administration. J Subst Abuse Treat. 2011 Oct;41(3):243-51. doi: 10.1016/j.jsat.2011.04.006. Epub 2011 Jun 12.

Wagner TH, Sethi G, Holman W, Lee K, Bakaeen FG, Upadhyay A, McFalls E, Tobler HG, Kelly RF, Crittenden MD, Thai H, Goldman S. Costs and quality of life associated with radial artery and saphenous vein cardiac bypass surgery: results from a Veterans Affairs multisite trial. Am J Surg. 2011 Nov;202(5):532-5. doi: 10.1016/j.amjsurg.2011.06.011. Epub 2011 Aug 26.


Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00054847 History of Changes
Other Study ID Numbers:	474
Study First Received:	February 11, 2003
Results First Received:	January 31, 2014
Last Updated:	April 18, 2014
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:


CABG cardiovascular chronic diseases clinical trial	heart multi-site trial prospective

Additional relevant MeSH terms:


Cardiovascular Diseases Coronary Artery Disease Coronary Disease Myocardial Ischemia	Arterial Occlusive Diseases Arteriosclerosis Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015