Randomized Endo-Vein Graft Prospective

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Bypass Grafting

Intervention / Treatment
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* Procedure: Vein Harvesting Procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endoscopic Vein Harvest (EVH)<br>An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length. | Procedure: Vein Harvesting Procedures<br>* Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH.<br>|
| Other: Open Vein Harvest (OVH)<br>Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as bridging technique) along the course of the vein. | Procedure: Vein Harvesting Procedures<br>* Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of First MACE During Active Follow-up Period. | 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. | Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE at One Year. | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively. | 1 year | 
| MACE at Three Years. | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively. | 3 years | 
| Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). | Incidence of first MACE estimated via Kaplan Meier survival analysis (MACE defined as death from any cause, repeat revascularization, myocardial infarction) during 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, CABG, Coronary revascularization, Endoscopic vein harvest, Saphenous vein graft, Graft failure