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

• ClinicalTrials.gov Identifier: NCT00187356
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: June 5, 2013
• Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Stephen E. Fremes, Sunnybrook Health Sciences Centre

Study Description

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.

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 269 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
• Study Start Date: July 2002
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. a) the proportion of occluded study grafts (TIMI 0) [ Time Frame: Beyond 5 years after bypass urgery ]
2. 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 ]
3. 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 ]
4. d) proportion of study grafts with string sign [ Time Frame: Beyond 5 years after bypass urgery ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

St. Michael's Hospital

Toronto, Ontario, Canada, M5B1W8

Toronto General Hospital

Toronto, Ontario, Canada, M5G2C4

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:

Related Info 

Publications of Results:

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.

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• 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
• Other Study ID Numbers: CIHR MCT# 52681
• First Posted: September 16, 2005
• Last Update Posted: June 5, 2013
• Last Verified: June 2013

Keywords provided by Stephen E. Fremes, Sunnybrook Health Sciences Centre:

Coronary Bypass Surgery; Coronary Artery Disease; Angiography; Arterial Grafts; Radial Artery; Saphenous Vein

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases