Randomized Endo-Vein Graft Prospective

NCT01850082 | Completed Results DMC

• 1 other identifier: 588
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 16

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.

Conditions

Coronary Artery Bypass Grafting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• MACE at One Year.

  1 year

• MACE at Three Years.

  3 years

• 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

Study Arms (2)

Endoscopic Vein Harvest (EVH)

OTHER

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 Harvest (OVH)

OTHER

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

Interventions

Vein Harvesting Procedures 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.

Endoscopic Vein Harvest (EVH); Open Vein Harvest (OVH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (16)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

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

Gainesville, Florida, 32608, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

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

New York, New York, 10010, United States

Location

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, 28805, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (6)

• 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.

  PMID: 24633760 BACKGROUND

• 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.

  PMID: 38007859 DERIVED

• 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.

  PMID: 37977259 DERIVED

• 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.

  PMID: 35727582 DERIVED

• 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.

  PMID: 31787434 DERIVED

• 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.

  PMID: 30417737 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Marco Zenati, M.D.
• Organization: VA Boston Healthcare System

Marco.Zenati@va.gov

857-203-6815

Study Officials

• Marco A Zenati, MD MSc

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 9, 2013
• Study Start: September 30, 2013
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 15, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)