Randomized Endo-Vein Graft Prospective

Coronary Artery Bypass Grafting Clinical Trial

— REGROUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850082
• Other study ID #: 588
• Status: Completed
• Phase: N/A
• Start date: September 30, 2013
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque, NM	Albuquerque	New Mexico
United States	Asheville VA Medical Center, Asheville, NC	Asheville	North Carolina
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida
United States	Clement J. Zablocki VA Medical Center, Milwaukee, WI	Milwaukee	Wisconsin
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida
United States	Southern Arizona VA Health Care System, Tucson, AZ	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zenati MA, Gaziano JM, Collins JF, Biswas K, Gabany JM, Quin JA, Bitondo JM, Bakaeen FG, Kelly RF, Shroyer AL, Bhatt DL. Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial. Clin Cardiol. 2014 Jun;37(6):325-30. doi: 10.1002/clc.22267. Epub 2014 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years
Secondary	MACE at One Year.	Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively.	1 year
Secondary	MACE at Three Years.	Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively.	3 years
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).	Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years