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| Name | Class |
|---|---|
| The Royal College of Surgeons of England | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| National Heart Foundation, Australia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saphenous vein | Active Comparator | Saphenous vein aortocoronary bypass graft |
|
| Radial artery | Experimental | Radial artery aortocoronary bypass graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery bypass graft (CABG) surgery | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patency Rates | Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography | 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. | 5 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Flow Volume | Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil E Moat, MS, FRCS | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton & Harefield NHS Trust | London | SW3 6NP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18506009 | Result | Collins P, Webb CM, Chong CF, Moat NE; Radial Artery Versus Saphenous Vein Patency (RSVP) Trial Investigators. Radial artery versus saphenous vein patency randomized trial: five-year angiographic follow-up. Circulation. 2008 Jun 3;117(22):2859-64. doi: 10.1161/CIRCULATIONAHA.107.736215. Epub 2008 May 27. | |
| 16722590 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saphenous Vein | Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery |
| FG001 | Radial Artery | Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saphenous Vein | Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery |
| BG001 | Radial Artery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patency Rates | Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography | 103 of the patients randomized at the time of surgery agreed to return for the 5-year follow-up angiogram. | Posted | Count of Participants | Participants | 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saphenous Vein | Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident (CVA) | Nervous system disorders | Non-systematic Assessment | Stroke |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Carolyn Webb | Imperial College London | 03301288860 | c.webb@imperial.ac.uk |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D058017 | Vascular Grafting |
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| Victor Phillip Dahdaleh Charitable Foundation |
| OTHER |
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| Chong WC, Collins P, Webb CM, De Souza AC, Pepper JR, Hayward CS, Moat NE. Comparison of flow characteristics and vascular reactivity of radial artery and long saphenous vein grafts [NCT00139399]. J Cardiothorac Surg. 2006 Mar 3;1:4. doi: 10.1186/1749-8090-1-4. |
| 20713903 | Result | Webb CM, Moat NE, Chong CF, Collins P. Vascular reactivity and flow characteristics of radial artery and long saphenous vein coronary bypass grafts: a 5-year follow-up. Circulation. 2010 Aug 31;122(9):861-7. doi: 10.1161/CIRCULATIONAHA.109.887000. Epub 2010 Aug 16. |
Radial artery aortocoronary bypass graft
Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | 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. | Intracoronary physiology investigations (diameter and intracoronary Doppler blood flow velocity measurements) were carried out in a subgroup of patients (n=27). | Posted | Mean | Standard Deviation | mm | 5 year follow-up |
|
|
|
| Secondary | Blood Flow Volume | Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire. | 27 of the patients who returned for the 5 year angiogram were eligible for invasive measurement of blood flow. | Posted | Mean | Standard Deviation | ml/min | 5 years |
|
|
|
| 4 |
| 60 |
| 11 |
| 60 |
| 0 |
| 60 |
| EG001 | Radial Artery | Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery | 3 | 82 | 13 | 82 | 0 | 82 |
|
| Percutaneous coronary intervention (PCI)/angio post surgery | Cardiac disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Myocardial infarction (MI) | Cardiac disorders | Non-systematic Assessment | Heart attack |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |