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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Stephen E. Fremes, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187356
First received: September 10, 2005
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a) the proportion of occluded study grafts (TIMI 0) [ Time Frame: Beyond 5 years after bypass urgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • d) proportion of study grafts with string sign [ Time Frame: Beyond 5 years after bypass urgery ] [ Designated as safety issue: No ]

Enrollment: 269
Study Start Date: July 2002
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00187356

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
London Health Sciences Centre - UC
London, Ontario, Canada, N6A 5A5
London Health Sciences Centre - VC
London, Ontario, Canada, N6B1B1
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sunnybrook and Women's College HSC
Toronto, Ontario, Canada, M4N3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Vancouver General Hospital
Vancouver, Ontario, Canada, V5Z1C6
Canada, Quebec
Laval Hospital
Laval, Quebec, Canada, G1V4G5
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Montreal Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Stephen E Fremes, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen E. Fremes, Head, Division of Cardiac and Vascular Surgery and Dr. Bernard S. Goldman Chair in Cardiovascular Surgery, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00187356     History of Changes
Other Study ID Numbers: CIHR MCT# 52681
Study First Received: September 10, 2005
Last Updated: June 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Coronary Bypass Surgery
Coronary Artery Disease
Angiography
Arterial Grafts
Radial Artery
Saphenous Vein

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014