Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery (RAPS - 5 years)

June 4, 2013 updated by: Stephen E. Fremes, Sunnybrook Health Sciences Centre
Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial arteries were more likely to be functioning than saphenous veins. We hypothesize that radial arteries will continue to be superior beyond 5 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

HYPOTHESES

  1. The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts.
  2. 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.

Study Type

Interventional

Enrollment (Actual)

269

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Manitoba Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - UC
      • London, Ontario, Canada, N6B1B1
        • London Health Sciences Centre - VC
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook and Women's College HSC
      • Vancouver, Ontario, Canada, V5Z1C6
        • Vancouver General Hospital
    • Quebec
      • Laval, Quebec, Canada, G1V4G5
        • Laval Hospital
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H3T 1E2
        • Montreal Jewish General Hospital
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January 2001. These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.

Exclusion Criteria:

Exclusion criteria included 1: Inability to use the radial artery or saphenous vein conduits: a)nonpalpable ulnar arteries or a positive Allen's test, b) an abnormal Doppler study or ultrasonographic study of the arms, c) a history of vasculitis or Raynaud's syndrome, bilateral varicose veins or vein stripping. 2: Conditions that affected the safety of follow-up angiography: a)renal insufficiency (creatinine > 180 umol/L) b)severe peripheral vascular disease precluding femoral access b)coagulopathy or obligatory uninterrupted use of anticoagulants c) known allergy to radiographic contrast media d) women of childbearing potential e) comorbid illness which precludes the use of follow up angiography f) geographically inaccessible for follow up angiography.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Beyond 5 years after bypass urgery

Secondary Outcome Measures

Outcome Measure
Time Frame
a) the proportion of occluded study grafts (TIMI 0)
Time Frame: Beyond 5 years after bypass urgery
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
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
Beyond 5 years after bypass urgery
d) proportion of study grafts with string sign
Time Frame: Beyond 5 years after bypass urgery
Beyond 5 years after bypass urgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Chair: Stephen E Fremes, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR MCT# 52681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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