Randomized Endo-Vein Graft Prospective

Status:	Active, not recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	3/6/2019
Start Date:	September 30, 2013
End Date:	October 30, 2019

CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial

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.

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.

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

We found this trial at

sites

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio 44106

Phone: 216-791-3800

from

Cleveland, OH