NCT00054847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
733

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

6 years

First QC Date

February 11, 2003

Results QC Date

January 31, 2014

Last Update Submit

April 18, 2014

Conditions

Cardiovascular DiseaseCoronary Artery Disease

Keywords

CABGcardiovascularchronic diseasesclinical trialheartmulti-site trialprospective

Outcome Measures

Primary Outcomes (1)

  • To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.

    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.

    1 year

Secondary Outcomes (3)

  • Death

    Within 1 year of surgery.

  • Myocardial Infarction

    Within 1 year of bypass surgery

  • Stroke

    Within 1 year of bypass surgery

Study Arms (2)

Saphenous Vein Graft

ACTIVE COMPARATOR

Saphenous Vein Graft

Procedure: saphenous vein graft

Radial Artery Graft

ACTIVE COMPARATOR

Radial Artery Graft

Procedure: radial artery graft

Interventions

saphenous vein graftPROCEDURE

Saphenous vein harvested from the arm is used as a conduit for CABG.

Saphenous Vein Graft
radial artery graftPROCEDURE

Radial artery harvested from the arm is used as a conduit for CABG.

Radial Artery Graft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients needing coronary artery bypass grafts.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, 72114-1706, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Southeast Veterans Healthcare System, New Orleans

New Orleans, Louisiana, 70112, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (10)

  • Mudumbai SC, Wagner T, Mahajan S, King R, Heidenreich PA, Hlatky M, Wallace A, Mariano ER. Vascular surgery patients prescribed preoperative beta-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.

    PMID: 22138312RESULT

  • 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.

    PMID: 22127268RESULT

  • 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.

    PMID: 22044350RESULT

  • 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.

    PMID: 22651986RESULT

  • 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.

    PMID: 22698772RESULT

  • 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.

    PMID: 21224458RESULT

  • 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.

    PMID: 21078416RESULT

  • 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.

    PMID: 21664790RESULT

  • 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.

    PMID: 21872209RESULT

  • Goldman S, McCarren M, Sethi GK, Holman W, Bakaeen FG, Wagner TH, Wang Y, Shih MC, Edson R; CSP #474 Investigators. Long-Term Mortality Follow-Up of Radial Artery Versus Saphenous Vein in Coronary Artery Bypass Grafting: A Multicenter, Randomized Trial. Circulation. 2022 Oct 25;146(17):1323-1325. doi: 10.1161/CIRCULATIONAHA.122.062343. Epub 2022 Oct 24. No abstract available.

    PMID: 36279414DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseChronic Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

There was more disease in the radial artery grafts at 1 week and at 1 year. There is more spasm or string sign in radial artery grafts. Study was conducted predominantly in men. Data show lower vein graft patency when endoscopic harvesting was used.

Results Point of Contact

Title
Steven Goldman, MD
Organization
Southern Arizona VA Health Care System
Steven.Goldman@va.gov
(520) 792-1450

Study Officials

  • Steven Goldman, MD

    Southern Arizona VA Health Care System

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2003

First Posted

February 13, 2003

Study Start

February 1, 2003

Primary Completion

February 1, 2009

Study Completion

February 1, 2010

Last Updated

May 5, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-04

Locations

US(11)