Radial Artery Versus Saphenous Vein Patency (RSVP) Study

Phase 3

Completed

• Conditions: Coronary Arteriosclerosis
• Interventions: Procedure: Coronary artery bypass graft (CABG) surgery

• Registration Number: NCT00139399
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Primary Completion: 2006-07
• Study Completion: 2006-11
• Results First Submitted: 2019-03-06
• Results First Submitted QC: 2019-03-06
• Status Verified: 2019-06
• Results First Posted: 2019-06-10
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saphenous vein	Coronary artery bypass graft (CABG) surgery	Saphenous vein aortocoronary bypass graft
Radial artery	Coronary artery bypass graft (CABG) surgery	Radial artery aortocoronary bypass graft

Primary Outcome Measures

Name	Time	Method
Patency Rates	5 years	Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)	5 year follow-up	Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.

Secondary Outcome Measures

Name	Time	Method
Blood Flow Volume	5 years	Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.

Trial Locations

Locations (1)

Royal Brompton & Harefield NHS Trust; 🇬🇧 London, United Kingdom