Randomized Endo-Vein Graft Prospective (REGROUP)

• ClinicalTrials.gov Identifier: NCT01850082
• Recruitment Status: Active, not recruiting
• First Posted: May 9, 2013
• Last Update Posted: August 26, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Bypass Grafting	Procedure: Vein Harvesting Procedures	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
• Actual Study Start Date: September 30, 2013
• Estimated Primary Completion Date: September 30, 2019
• Estimated Study Completion Date: October 30, 2019

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. Investigate the impact of SVG harvesting techniques - OVH vs. EVH on MACE, a composite end point of all-cause mortality, nonfatal myocardial infarction and repeat revascularization, over the active follow-up period of the study postoperatively. [ Time Frame: 4.5 Years ]
   The primary efficacy end point is the composite rate of death from any cause, myocardial infarction or repeat revascularization (Major Adverse Cardiac Events - MACE) throughout the multi-year Study period. Each randomized subject (either in the Endoscopic or in the Open vein harvesting group) will be followed after the index CABG to capture the time-to-MACE event, where an 'EVENT' will be defined as either death (all cause) or a myocardial infarction or a revascularization procedure during the follow-up period.

Secondary Outcome Measures :

1. Investigate the impact of SVG harvesting techniques - OVH vs. EVH on MACE, a composite endpoint of all-cause mortality, nonfatal myocardial infarction and repeat revascularization, at one and three-year postoperatively. [ Time Frame: 6.5 years ]
   The secondary efficacy end point is the MACE rate at one and three-years post-CABG. The investigators believe that the proposed CSP# 588 REGROUP Trial will be uniquely positioned to fill a significant gap in existing knowledge regarding the long term MACE rates of EVH in CABG and improve the quality of the care we provide to our Veterans and more broadly to all patients undergoing coronary revascularization. In addition, the investigators believe that CSP# 588 findings will significantly impact the VA and national cardiac surgery coronary revascularization guidelines.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States, 85723

United States, California

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States, 94121

United States, Florida

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

Gainesville, Florida, United States, 32608

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States, 33125

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States, 33612

United States, Massachusetts

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

Boston, Massachusetts, United States, 02130

United States, Minnesota

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417

United States, New Mexico

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, United States, 87108-5153

United States, New York

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

New York, New York, United States, 10010

United States, North Carolina

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, United States, 28805

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705

United States, Ohio

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106

United States, Oregon

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97239

United States, Pennsylvania

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States, 15240

United States, Texas

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States, 77030

United States, Wisconsin

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States, 53295-1000

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Study Chair: Marco A Zenati, MD MSc; VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

More Information

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01850082 History of Changes
• Other Study ID Numbers: 588
• First Posted: May 9, 2013
• Last Update Posted: August 26, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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