CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Bypass Grafting
- Sponsor
- VA Office of Research and Development
- Enrollment
- 1150
- Locations
- 16
- Primary Endpoint
- Incidence of First MACE During Active Follow-up Period.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
CSP #588 - REGROUP is a randomized, intent-to-treat, two-arm, parallel design, multicenter study. Cardiac Surgery Programs at Veterans Affairs Medical Centers (VAMC) with expertise in performing both EVH and OVH will be invited to participate in the study. Subjects requiring elective or urgent CABG using cardiopulmonary bypass with use of at least one SVG will be screened for enrollment using established inclusion/exclusion criteria. Enrolled Subjects will be randomized to one of the two arms (EVH or OVH) after an experienced vein harvester is identified and assigned. Intraoperative assessments will be collected and post-operative assessments will be completed 24 hours post-surgery. Additional assessments will be completed at the time of discharge or at the 30-day post-surgery date if the subject is still in the hospital. Assessment of leg wound complications will be completed at the time of discharge and at six-week post-surgery. Telephone follow-ups will occur at three-month interval post-surgery until the participating sites are decommissioned at the end of the trial period (which would be approximately 4.5 years after the site initiations). For long-term MACE outcomes, passive follow up for MACE events using VA databases (CPRS, VASQIP) will be performed centrally by the Study Chair's office for another 2 years.
Investigators
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
Outcomes
Primary Outcomes
Incidence of First MACE During Active Follow-up Period.
Time Frame: Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years
Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during the active follow-up period.
Secondary Outcomes
- MACE at One Year.(1 year)
- MACE at Three Years.(3 years)
- Incidence of First MACE Over the Entire Follow-up Period (Active and Passive).(Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years)