Radial Artery Versus Saphenous Vein Patency (RSVP) Study

Imperial College London142 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Coronary Arteriosclerosis

Interventions

Coronary artery bypass graft (CABG) surgeryPROCEDURE

Patients were randomized to receive either a radial artery or a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Brompton & Harefield NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

Patency Rates

Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography

Time frame: 5 years

Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)

Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.

Time frame: 5 year follow-up

Secondary Outcomes

Blood Flow Volume

Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.

Time frame: 5 years

Data from ClinicalTrials.gov

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