Radial Artery Versus Saphenous Vein Patency (RSVP) Trial - 10 Year Follow-up

Study Overview
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Brief Summary
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During coronary bypass surgery, veins are taken from the leg and applied to the heart and aorta to 'bypass' narrowings in the coronary arteries. However using an artery in the chest, the internal mammary artery, means that the bypass lasts longer than using veins. The investigators recently showed that using an artery from the arm as a bypass vessel, the radial artery, also had less furring up than veins 5 years after surgery. Now the investigators would like to ask patients to come back for an angiogram 10 years following surgery.

Official Title
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Randomised, Controlled Trial Comparing Angiographic Patency of the Radial Artery Versus the Saphenous Vein Used as Free Aorto-coronary Grafts in Coronary Revascularisation (RSVP Trial) - 10-year Follow-up

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary artery bypass (CABG) surgery using a radial arterial conduit
* Procedure: Coronary artery bypass surgery using a long saphenous vein conduit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Included in the RSVP study Willing to attend for coronary angiography Willing to give written informed consent Exclusion Criteria: Contraindication to coronary angiography participation in research project within previous 60 days unwilling to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial artery<br>Use of the radial artery as a conduit in CABG surgery | Procedure: Coronary artery bypass (CABG) surgery using a radial arterial conduit<br>* Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery<br>|
| Active Comparator: Long saphenous vein<br>Use of long saphenous vein as a conduit in CABG surgery | Procedure: Coronary artery bypass surgery using a long saphenous vein conduit<br>* Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of radial artery and saphenous vein grafts patent at 10 years | Comparison of the patency of radial artery and long saphenous aorto-coronary bypass grafts at 10 years, assessed by an independent observer | 10 years post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic visual grading | Compare secondary angiographic visual grading in radial artery and long saphenous vein grafts | 10 years post surgery | 
| Patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts | Compare the patency (patent or complete occlusion, and secondary visual grading) of radial artery and internal mammary artery coronary bypass grafts | 10 years post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass surgery, Arteries, Veins, Conduits