Randomized Endovein Graft Prospective - REGROUP

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 2.8 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:

  • 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. Endoscopic vein graft harvest was associated with marginally fewer leg infections; therefore, this harvest technique may be considered preferential.

References:

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.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: AHA Annual Scientific Sessions, 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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