Coronary Artery Bypass Grafting
Conditions
Keywords
Coronary artery disease, CABG, Coronary revascularization, Endoscopic vein harvest, Saphenous vein graft, Graft failure
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.
Interventions
PROCEDUREVein Harvesting Procedures
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of First MACE During Active Follow-up Period. | 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
| Measure | Time frame | Description |
|---|---|---|
| MACE at One Year. | 1 year | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively. |
| MACE at Three Years. | 3 years | Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively. |
| 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endoscopic Vein Harvest (EVH) 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.
Vein Harvesting Procedures: 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. | 576 |
| Open Vein Harvest (OVH) 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.
Vein Harvesting Procedures: 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. | 574 |
| Total | 1,150 |
Baseline characteristics
| Characteristic | Endoscopic Vein Harvest (EVH) | Open Vein Harvest (OVH) | Total |
|---|---|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 6.7 | 66.6 Years STANDARD_DEVIATION 7.1 | 66.4 Years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Black, not of Hispanic origin | 41 Participants | 50 Participants | 91 Participants |
| Race/Ethnicity, Customized Hispanic | 31 Participants | 31 Participants | 62 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized , not of Hispanic origin | 490 Participants | 484 Participants | 974 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 572 Participants | 571 Participants | 1143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 69 / 576 | 76 / 574 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 366 / 576 | 359 / 574 |
Outcome results
Primary
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.
Time frame: Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years
Population: Events captured during the active follow-up phase of the trial (minimum of 1 year and up to 4.5 years) were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | Incidence of First MACE During Active Follow-up Period. | 80 Participants |
| Open Vein Harvest (OVH) | Incidence of First MACE During Active Follow-up Period. | 89 Participants |
p-value: 0.4795% CI: [0.83, 1.51]Regression, Cox
Secondary
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).
Time frame: Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years
Population: Events captured throughout active and passive follow-up are included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). | 126 Participants |
| Open Vein Harvest (OVH) | Incidence of First MACE Over the Entire Follow-up Period (Active and Passive). | 135 Participants |
p-value: 0.51795% CI: [0.724, 1.176]Regression, Cox
Secondary
MACE at One Year.
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively.
Time frame: 1 year
Population: Participants with a minimum of 1 year follow-up or who died within one year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | MACE at One Year. | 45 Participants |
| Open Vein Harvest (OVH) | MACE at One Year. | 47 Participants |
p-value: 0.821Chi-squared
Secondary
MACE at Three Years.
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively.
Time frame: 3 years
Population: Participants with a minimum of 3 years follow-up or died prior to 3 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | MACE at Three Years. | 90 Participants |
| Open Vein Harvest (OVH) | MACE at Three Years. | 90 Participants |
p-value: >0.99Chi-squared