Randomized Endo-Vein Graft Prospective

NCT ID: NCT01850082

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2020-10-30

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.

Conditions

Coronary Artery Bypass Grafting

Keywords

Coronary artery disease; CABG; Coronary revascularization; Endoscopic vein harvest; Saphenous vein graft; Graft failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Vein Harvesting Procedures

Intervention Type: PROCEDURE

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.

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.

Group Type: OTHER

Vein Harvesting Procedures

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco A Zenati, MD MSc

Role: STUDY_CHAIR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24633760 (View on PubMed)

Almassi GH, Quin JA, Stock EM, DeMatt EJ, Biswas K, Hattler B, Tseng E, Zenati MA. Impact of Oral Anticoagulation on Clinical Outcomes in Postoperative Atrial Fibrillation. J Surg Res. 2024 Mar;295:122-130. doi: 10.1016/j.jss.2023.10.016. Epub 2023 Nov 25.

Reference Type: DERIVED

PMID: 38007859 (View on PubMed)

Gikandi A, Habertheuer A, Stock EM, Hirji S, Kinlay S, Tsao A, Butala N, Biswas K, Zenati MA. Anatomical SYNTAX score and major adverse cardiac events following CABG in the REGROUP trial. J Cardiol. 2024 May;83(5):348-350. doi: 10.1016/j.jjcc.2023.11.003. Epub 2023 Nov 17. No abstract available.

Reference Type: DERIVED

PMID: 37977259 (View on PubMed)

Wagner TH, Hattler B, Stock EM, Biswas K, Bhatt DL, Bakaeen FG, Gujral K, Zenati MA. Costs of Endoscopic vs Open Vein Harvesting for Coronary Artery Bypass Grafting: A Secondary Analysis of the REGROUP Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217686. doi: 10.1001/jamanetworkopen.2022.17686.

Reference Type: DERIVED

PMID: 35727582 (View on PubMed)

Shapeton AD, Leissner KB, Zorca SM, Amirfarzan H, Stock EM, Biswas K, Haime M, Srinivasa V, Quin JA, Zenati MA. Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):726-732. doi: 10.1053/j.jvca.2019.10.053. Epub 2019 Nov 9.

Reference Type: DERIVED

PMID: 31787434 (View on PubMed)

Zenati MA, Bhatt DL, Bakaeen FG, Stock EM, Biswas K, Gaziano JM, Kelly RF, Tseng EE, Bitondo J, Quin JA, Almassi GH, Haime M, Hattler B, DeMatt E, Scrymgeour A, Huang GD; REGROUP Trial Investigators. Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass. N Engl J Med. 2019 Jan 10;380(2):132-141. doi: 10.1056/NEJMoa1812390. Epub 2018 Nov 11.

Reference Type: DERIVED

PMID: 30417737 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

588

Identifier Type: -

Identifier Source: org_study_id