The REGROUP trial: endoscopic and open vein-graft harvest associated with similar outcomes

1. Among patients randomized to an open or endoscopic vein-graft harvest technique for coronary-artery bypass graft (CABG) surgery, there was no difference in major adverse cardiovascular events (MACE) over a median follow-up of 2.78 years.

2. The rate of leg wound complications was lower in the endoscopic-harvest group compared to the open-harvest group.

Evidence Rating Level: 1 (Excellent)      

Study Rundown: Patients undergoing CABG surgery usually have one or more vein grafts placed, which may be harvested using an open or endoscopic technique. Though studies have demonstrated lower rates of harvest-site complications and less pain with the endoscopic technique, vein-graft patency has been consistently lower compared to the open technique. Given that prior studies featured relatively small sample sizes with short follow-up, the Randomized Endovein Graft Prospective (REGROUP) trial was designed to assess clinical outcomes of open or endoscopic vein-graft harvesting in CABG surgery. Investigators found no significant difference in the primary outcome, the first occurrence of a MACE, between open and endoscopic vein-graft harvesting. Furthermore, there was no difference in any of the individual components of the primary outcome and the endoscopic technique was associated with a lower rate of wound complications compared to the open technique. The results suggest endoscopic harvest by an expert surgeon may be the preferred harvesting modality going forward, though further evidence with multiple arterial grafts and the open “no touch” vein-graft harvest technique may impact clinical practice.

This was the largest study to compare the open and endoscopic vein-graft harvest techniques for CABG. A key feature of this study was the high level of expertise required for vein harvesters. Limited information regarding operator expertise has been a criticism of previous studies, but this requirement also limits generalizability of this study’s results. Further limiting generalizability is the exclusion of the open “no touch” technique, which may have superior outcomes to traditional open harvesting.

Click to read the study in NEJM

Relevant Reading: Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery

In-Depth [randomized controlled trial]: Patients (n=1150) at Veterans Affairs cardiac surgery centers who were undergoing elective or urgent CABG with at least one saphenous vein graft were randomly assigned to endoscopic (n=576) or open (n=574) vein-graft harvesting. Only endoscopic vein-graft harvesters with more than 100 endoscopic vein harvesting cases and <5% conversion rate to open harvesting were invited to participate in the trial. The open “no touch” technique of vein-graft harvesting was not practiced at any site in the study. Following randomization, patients were assessed at baseline, surgery, after surgery, at discharge, at six weeks, and every three months thereafter for a minimum of one year. The primary outcome was the first MACE (composite of death from any cause, nonfatal myocardial infarction, or repeat revascularization) in a time-to-event analysis over the active follow-up period. A secondary outcome included was MACE at one year after surgery. Individual components of the primary outcome, incisional leg pain, and leg wound infections were also assessed.

Median follow-up time was 2.78 years. During active follow-up, the primary outcome occurred in 89 patients (15.5%) in the open group versus 80 patients (13.9%) in the endoscopic group (hazard ratio [HR], 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). In the open versus endoscopic group: death occurred in 46 patients (8.0%) versus 37 patients (6.4%) (HR, 1.25; 95% CI, 0.81 to 1.92), myocardial infarction occurred in 34 patients (5.9%) versus 27 patients (4.7%) (HR, 1.27; 95% CI, 0.77 to 2.11), and repeat revascularization occurred in 35 patients (6.1%) versus 31 patients (5.4%) (HZ, 1.14; 95% CI, 0.70 to 1.85), respectively. The one-year rate of MACEs was 8.2% versus 7.8% for the open and endoscopic groups, respectively. Leg wound infections occurred in 18 patients (3.1%) in the open group versus 8 patients (1.4%) in the endoscopic group (relative risk [RR], 2.26; 95% CI, 0.99 to 5.15). There was no functional impairment from incisional leg pain in 62.2% of patients in the open group versus 79.1% in the endoscopic group (RR, 0.79; 95% CI, 0.73 to 0.85).

Image: PD

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