N/A
N=1,150
Randomized Endo-Vein Graft Prospective
Coronary Artery Bypass Grafting
Bottom Line
View on ClinicalTrials.gov: NCT01850082 ↗Enrolled (actual)
1,150
Serious AEs
63.0%
Results posted
Nov 2021
Primary outcome: Primary: Incidence of First MACE During Active Follow-up Period. — 80; 89 Participants — p=0.47
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vein Harvesting Procedures (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of First MACE During Active Follow-up Period. |
80; 89 | 0.47 |
| SECONDARY MACE at One Year. |
45; 47 | 0.821 |
| SECONDARY MACE at Three Years. |
90; 90 | >0.99 |
| SECONDARY Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). |
126; 135 | 0.517 |
Summary
Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the United States with over 300,000 cases performed each year. To restore blood flow to the heart, vascular conduits from another part of the body are procured to create a bypass around critically blocked coronary arteries. The left internal thoracic artery is the conduit of choice for CABG due to its superior long-term patency. However, almost all patients referred for CABG require additional grafts to provide complete revascularization. This necessitates the harvest of other vessels, most commonly the saphenous vein which is used almost ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred method over the traditional open harvesting technique (OVH) because it provides a minimally invasive approach. However, more recent investigations indicate potential for reduced long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of EVH on clinical outcomes has never been investigated on a large scale using a definitive, adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.
Eligibility Criteria
Inclusion Criteria
- Age years 18 years or older
- Elective or Urgent CABG-only
- Median sternotomy approach
- At least one coronary bypass planned using saphenous vein graft for conduit
- Experienced EVH/OVH harvester available for procedure
Exclusion Criteria
- Combined valve procedure planned
- Moderate or severe valve disease (see definition of moderate/severe valve)
- Hemodynamically unstable or in cardiogenic shock
- Enrolled in another therapeutic or interventional study
- Off-pump CABG procedure planned
- Limited life expectancy < 1 year
- History of lower extremities venous stripping or ligation
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01850082). 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.