Coronary Artery Bypass GraftingREGROUPNCT01850082
Randomized Endo-Vein Graft Prospective
A study testing Vein Harvesting Procedures in people with Coronary Artery Bypass Grafting, run by VA Office of Research and Development at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Vein Harvesting Procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 Sep 2013to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, 28805
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
About this study
Official title: CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
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.
Read the 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
- Being tested
- Vein Harvesting Procedures
- Keywords
- Coronary artery disease, CABG, Coronary revascularization, Endoscopic vein harvest, Saphenous vein graft, Graft failure
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein Harvesting ProceduresProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Vein Harvesting Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years
Secondary outcomes (3)
MACE at One Year.
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at one year postoperatively.
Measured: 1 year
MACE at Three Years.
Proportion of patients with MACE (death from any cause, repeat revascularization, myocardial infarction) at three years postoperatively.
Measured: 3 years
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).
Measured: Varying timeframe for each participant with a minimum of 3 years and a maximum of 6.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start30 Sep 2013
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marco A Zenati, MD MSc, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850082
- Sponsor's protocol ID
- 588
- Acronym
- REGROUP
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2013
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24633760Gikandi A, Stock EM, Dematt E, Quin J, Hirji S, Biswas K, Zenati MA. Chronic total occlusions and coronary artery bypass grafting outcomes. J Thorac Cardiovasc Surg. 2025 Jul;170(1):216-227.e3. doi: 10.1016/j.jtcvs.2024.08.016. Epub 2024 Aug 21.
PubMed 39173708Almassi 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.
PubMed 38007859Gikandi 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.
PubMed 37977259Wagner 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.
PubMed 35727582Shapeton 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.
PubMed 31787434Zenati 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.
PubMed 30417737
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
- ClinicalTrials.gov ID
- NCT01850082
- Acronym / sponsor ID
- REGROUP / 588
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Coronary artery disease, CABG, Coronary revascularization, Endoscopic vein harvest, Saphenous vein graft, Graft failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Vein Harvest (EVH) | Other | Procedure: Vein Harvesting ProceduresAn 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. |
| Open Vein Harvest (OVH) | Other | Procedure: Vein Harvesting ProceduresOpen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vein Harvesting ProceduresOpen 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. | Procedure or surgery | Endoscopic Vein Harvest (EVH), Open Vein Harvest (OVH) |
Primary outcome
Incidence of First MACE During Active Follow-up Period.
Time frame: 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.
3 secondary outcomes
MACE at One Year.
Time frame: 1 year
MACE at Three Years.
Time frame: 3 years
Incidence of First MACE Over 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24633760Zenati 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.
- Derived from this study: PubMed 39173708Gikandi A, Stock EM, Dematt E, Quin J, Hirji S, Biswas K, Zenati MA. Chronic total occlusions and coronary artery bypass grafting outcomes. J Thorac Cardiovasc Surg. 2025 Jul;170(1):216-227.e3. doi: 10.1016/j.jtcvs.2024.08.016. Epub 2024 Aug 21.
- Derived from this study: PubMed 38007859Almassi 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.
- Derived from this study: PubMed 37977259Gikandi 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.
- Derived from this study: PubMed 35727582Wagner 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.
- Derived from this study: PubMed 31787434Shapeton 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.
- Derived from this study: PubMed 30417737Zenati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Zenati, MD MSc study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein Harvesting Procedures in people with Coronary Artery Bypass Grafting, run by VA Office of Research and Development at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of First MACE During Active Follow-up Period. (time frame: Varying timeframe for each participant with a minimum of 1 year and a maximum 4.5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850082, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021; AzTrials last refreshed its copy on 29 Oct 2026.