Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery

NCT ID: NCT00187356

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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%.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Stephen E. Fremes

Head, Division of Cardiac and Vascular Surgery and Dr. Bernard S. Goldman Chair in Cardiovascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen E Fremes, MD

Role: STUDY_CHAIR

Sunnybrook Health Sciences Centre

Locations

University of Alberta

Edmonton, Alberta, Canada

Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada

London Health Sciences Centre - UC

London, Ontario, Canada

London Health Sciences Centre - VC

London, Ontario, Canada

Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook and Women's College HSC

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Vancouver General Hospital

Vancouver, Ontario, Canada

Laval Hospital

Laval, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Montreal Jewish General Hospital

Montreal, Quebec, Canada

Waikato Hospital

Hamilton, , New Zealand

Countries

Canada; New Zealand

References

Fremes SE. Multicenter radial artery patency study (RAPS). Study design. Control Clin Trials. 2000 Aug;21(4):397-413. doi: 10.1016/s0197-2456(00)00059-3.

Reference Type: BACKGROUND

PMID: 10913815 (View on PubMed)

Desai ND, Cohen EA, Naylor CD, Fremes SE; Radial Artery Patency Study Investigators. A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts. N Engl J Med. 2004 Nov 25;351(22):2302-9. doi: 10.1056/NEJMoa040982.

Reference Type: RESULT

PMID: 15564545 (View on PubMed)

Deb S, Cohen EA, Singh SK, Une D, Laupacis A, Fremes SE; RAPS Investigators. Radial artery and saphenous vein patency more than 5 years after coronary artery bypass surgery: results from RAPS (Radial Artery Patency Study). J Am Coll Cardiol. 2012 Jul 3;60(1):28-35. doi: 10.1016/j.jacc.2012.03.037.

Reference Type: RESULT

PMID: 22742399 (View on PubMed)

Tam DY, Deb S, Nguyen B, Ko DT, Karkhanis R, Moussa F, Fremes J, Cohen EA, Radhakrishnan S, Fremes SE. The radial artery is protective in women and men following coronary artery bypass grafting-a substudy of the radial artery patency study. Ann Cardiothorac Surg. 2018 Jul;7(4):492-499. doi: 10.21037/acs.2018.05.19.

Reference Type: DERIVED

PMID: 30094213 (View on PubMed)

Deb S, Singh SK, Moussa F, Tsubota H, Une D, Kiss A, Tomlinson G, Afshar M, Sless R, Cohen EA, Radhakrishnan S, Dubbin J, Schwartz L, Fremes SE; Radial Artery Patency Study Investigators. The long-term impact of diabetes on graft patency after coronary artery bypass grafting surgery: a substudy of the multicenter Radial Artery Patency Study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1246-53; discussion 1253. doi: 10.1016/j.jtcvs.2014.06.057. Epub 2014 Jul 17.

Reference Type: DERIVED

PMID: 25109754 (View on PubMed)

Yanagawa B, Algarni KD, Singh SK, Deb S, Vincent J, Elituv R, Desai ND, Rajamani K, McManus BM, Liu PP, Cohen EA, Radhakrishnan S, Dubbin JD, Schwartz L, Fremes SE. Clinical, biochemical, and genetic predictors of coronary artery bypass graft failure. J Thorac Cardiovasc Surg. 2014 Aug;148(2):515-520.e2. doi: 10.1016/j.jtcvs.2013.10.011. Epub 2013 Dec 9.

Reference Type: DERIVED

PMID: 24332189 (View on PubMed)

Related Links

http://sunnybrook.ca/media/item.asp?c=2&i=240&page=524

Related Info

Other Identifiers

CIHR MCT# 52681

Identifier Type: -

Identifier Source: org_study_id