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Cardiovascular DiseaseNCT00054847

Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery

A study testing saphenous vein graft and radial artery graft in people with Cardiovascular Disease and Coronary Artery Disease, run by US Department of Veterans Affairs at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
saphenous vein graft and radial artery graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
733 participants
Where
11 sitesUnited States
Study dates
Feb 2003to Feb 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients needing coronary artery bypass grafts.

Who cannot join

  • 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
Show all 17Show fewer
  • 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)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites
  • New Mexico VA Health Care System, Albuquerque

    Albuquerque, New Mexico, 87108-5153

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48113

  • VA Medical Center, Birmingham

    Birmingham, Alabama, 35233

  • VA Boston Healthcare System, Brockton Campus

    Brockton, Massachusetts, 02301

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141-5000

  • Michael E. DeBakey VA Medical Center (152)

    Houston, Texas, 77030

  • VA Medical Center, Minneapolis

    Minneapolis, Minnesota, 55417

  • Southeast Veterans Healthcare System, New Orleans

    New Orleans, Louisiana, 70112

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

    No. Little Rock, Arkansas, 72114-1706

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

Other trials in United States

About this study

Official title: CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)

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.

Read the 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 efficacy/patency 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 patient's arm are the main exclusion criteria. These include Raynaud's 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 hand/leg 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.

Being tested
saphenous vein graft, radial artery graft
Keywords
CABG, cardiovascular, chronic diseases, clinical trial, heart, multi-site trial, prospective
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saphenous vein graftProcedure or surgery

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

  • radial artery graftProcedure or surgery

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

Study groups in NCT00054847
Study groupRoleWhat they receive
Saphenous Vein GraftActive comparatorSaphenous Vein Graft
Receives: Procedure: saphenous vein graft
Radial Artery GraftActive comparatorRadial Artery Graft
Receives: Procedure: radial artery graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (3)
  1. Death

    Measured: Within 1 year of surgery.

  2. Myocardial Infarction

    Measured: Within 1 year of bypass surgery

  3. Stroke

    Measured: Within 1 year of bypass surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionFeb 2009
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
733 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054847
Sponsor's protocol ID
474
Status last verified
Apr 2014
First submitted
11 Feb 2003
Last updated
5 May 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22138312
  • 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.

    PubMed 22127268
  • 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.

    PubMed 22044350
  • 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.

    PubMed 22651986
  • 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.

    PubMed 22698772
  • 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.

    PubMed 21224458
  • 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.

    PubMed 21078416
  • 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.

    PubMed 21664790
  • 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.

    PubMed 21872209
  • 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.

    PubMed 36279414

Questions about this trial

What is this clinical trial studying?

A study testing saphenous vein graft and radial artery graft in people with Cardiovascular Disease and Coronary Artery Disease, run by US Department of Veterans Affairs at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054847, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.

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