N/A
N=733
Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery
Cardiovascular Disease · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00054847 ↗Enrolled (actual)
733
Serious AEs
45.0%
Results posted
Mar 2014
Primary outcome: Primary: To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. — 269; 266 grafts — p=.82
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- saphenous vein graft (Procedure); radial artery graft (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. |
269; 266 | .82 |
| SECONDARY Death |
7; 9 | .61 |
| SECONDARY Myocardial Infarction |
5; 4 | >.99 |
| SECONDARY Stroke |
6; 7 | — |
Summary
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.
Eligibility Criteria
Inclusion Criteria
- Patients needing coronary artery bypass grafts.
Exclusion Criteria
- Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
- Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
- Patients with Raynaud's symptoms
- Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
- Patients with a positive Allen test
- Patients with cardiogenic shock
- Patients who are unable to give consent
- Patients allergic to contrast material
- Patients undergoing repeat CABG or any form of robotic surgery
- Patients who do not have full use of both arms
- Patients who are pregnant
- Patients with neurologic or musculoskeletal disease affecting the arm
- Patients who refuse to participate
- Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.
- Patient requires concomitant Dor or Maze procedure
- Patient is in another research study
- No suitable radial target (there is no non-LAD vessel with a >70% stenosis)
Data sourced from ClinicalTrials.gov (NCT00054847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.