Radial Artery Versus Saphenous Vein Patency (RSVP) Study

Imperial College London

Status and phase: Completed; Phase 3

Conditions: Coronary Arteriosclerosis

Treatments: Procedure: Coronary artery bypass graft (CABG) surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00139399

LREC 98-010

Details and patient eligibility

About

The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.

Full description

Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term.

The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.

Enrollment: 142 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• on waiting list for clinically-indicated myocardial revascularization surgery
• aged 40-70 years
• significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms
• negative Allen's test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression)
• willing to give written informed consent

Exclusion criteria

• poor left ventricular (LV) function (LV ejection fraction <25%)
• severe diffuse peripheral vascular disease or bilateral varicose venous disease
• inability to comply with the angiographic follow-up at 3 months or/and 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Saphenous vein

Active Comparator group

Description:

Saphenous vein aortocoronary bypass graft

Treatment:

Procedure: Coronary artery bypass graft (CABG) surgery

Radial artery

Experimental group

Description:

Radial artery aortocoronary bypass graft

Treatment:

Procedure: Coronary artery bypass graft (CABG) surgery