Randomized Endovein Graft Prospective - REGROUP

Nov 14, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs.
Date Presented:
11/13/2020
Date Published:
01/10/2019
Date Updated:
11/14/2020
Original Posted Date:
11/11/2018
References

Contribution To Literature:

The REGROUP trial showed similar outcomes between endoscopic vein harvest and open vein harvest.

Description:

The goal of the trial was to evaluate endoscopic vein graft harvest compared with open vein graft harvest among patients undergoing coronary artery bypass grafting (CABG).

Study Design

  • Randomized
  • Parallel

Patients undergoing CABG were randomized to endoscopic vein harvest (n = 576) versus open vein harvest (n = 574).

  • Total number of enrollees: 1,150
  • Duration of follow-up: median 4.7 years
  • Mean patient age: 66 years
  • Percentage female: 0.5%
  • Percentage with diabetes: 49%

Inclusion criteria:

  • Patients undergoing CABG with ≥1 saphenous vein bypass graft
  • Elective or urgent surgery
  • Availability of an expert endoscopic vein harvester

Exclusion criteria:

  • Off-pump CABG
  • Non-sternotomy approach
  • Need for cardiac surgery other than CABG

Principal Findings:

The primary outcome, death, myocardial infarction (MI), or repeat revascularization, occurred in 13.9% of the endoscopic vein graft group vs. 15.5% of the open vein graft group (hazard ratio 1.12, 95% confidence interval 0.83-1.51, p = 0.47). The individual component of the composite outcome was similar between treatment groups.

Secondary outcomes:

  • Primary outcome at a median of 4.7 years: 21.9% with endoscopic vein graft harvest vs. 23.5% with open vein graft harvest (p = 0.52)
  • All-cause mortality: 6.4% with endoscopic vein graft harvest vs. 8.0% with open vein graft harvest (p = not significant [NS])
  • MI: 4.7% with endoscopic vein graft harvest vs. 5.9% with open vein graft harvest (p = NS)
  • All-cause mortality: 5.4% with endoscopic vein graft harvest vs. 6.1% with open vein graft harvest (p = NS)
  • Leg wound infection: 1.4% with endoscopic vein graft harvest vs. 3.1% with open vein graft harvest (p = NS)

Interpretation:

Among male patients undergoing CABG with ≥1 saphenous vein bypass graft, major adverse cardiac events were similar between endoscopic vein graft and open vein graft harvest. There was no difference in major adverse cardiac events with long-term follow-up. Endoscopic vein graft harvest was associated with marginally fewer leg infections; therefore, this harvest technique may be considered preferential.

References:

Presented by Dr. Marco A. Zenati at the American Heart Association Virtual Scientific Sessions, November 13, 2020.

Zenati MA, Bhatt DL, Bakaeen FG, et al., on behalf of the REGROUP Trial Investigators. Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass. N Engl J Med 2019;380:132-41.

Editorial: Verma S, Mazer CD. Open or Endoscopic Vein Harvesting for Coronary-Artery Bypass Grafting. N Engl J Med 2019;380:189-91.

Presented by Dr. Marco A. Zenati at the American Heart Association Annual Scientific Sessions (AHA 2018), Chicago, IL, November 11, 2018.

Keywords: AHA Annual Scientific Sessions, AHA20, AHA18, Cardiac Surgical Procedures, Coronary Artery Bypass, Endoscopy, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Saphenous Vein, Tissue and Organ Harvesting, Wound Infection


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