VA Cooperative Studies Program (CSP)
CSP #588 No Difference Between Open and Endoscopic Vein Graft in Open-Heart Surgery
No Difference Between Open and Endoscopic Vein Graft in Open-Heart Surgery
REGROUP multicenter trial results show no significant difference in major adverse cardiac events
Investigators Report REGROUP Trial Results in NEJM
Results published in NEJM found no differences in major adverse cardiac events between open vein-graft harvest and endoscopic vein-graft harvest in a follow-up period of nearly 3 years.
The greater saphenous vein (GSV) is the most commonly used conduit in coronary artery bypass grafting (CABG)—or open-heart surgery—because of its ease of access and use. But, there are limitations that include vein-graft failure, infection and pain.
Endoscopic vein grafting—a minimally invasive alternative to open vein-graft harvesting—was introduced in the mid-1990s to address these limitations, and is used today in more than 90 percent of CABG surgeries. CSP played a key role in establishing its effectiveness. While the procedure reduces infections that may happen during leg wound healing, the evidence for its long-term safety is limited by small trials with short follow up. In addition, some data show graft failure is more likely to occur following endoscopic harvest than with open harvest.
In response to this clinical gap, investigators, including Study Chair Marco Zenati, MD, from VA Boston Healthcare System, developed the VA Cooperative Study #588 - Randomized Endovein Graft Prospective (REGROUP) trial to assess the clinical outcomes of open versus endoscopic vein-graft harvest in CABG surgery. The multicenter study included 16 VA cardiac surgery centers with 1,150 randomized patients—574 assigned to open vein-graft harvesting; 576 assigned to endoscopic vein-graft harvesting.
The REGROUP trial endpoints included the following:
- Primary outcome: time to a major adverse cardiac event—including all-cause mortality, nonfatal heart attack and repeat revascularization
- Secondary outcome: major adverse cardiac event at 1 year after surgery
- Tertiary outcome: leg wound infection and pain
More particularly, investigators reported the following observations:
- During active follow up, the primary outcome of major adverse cardiac events occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group.
- Death occurred in 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group.
- Heart attack occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group.
- Repeat revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group.
- The one-year major adverse cardiac event rate was 8.2% for open harvest and 7.8% for endoscopic harvest.
- Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group.
- There was no or little impact of incisional leg pain on patient functioning in 62.2% of patients in the open-harvest group compared with 79.1% in the endoscopic-harvest group at six weeks postoperatively.
Investigators noted that an important feature of the REGROUP study design was its high-level expertise among vein harvesters—open and endoscopic—something that was not part of previous studies. In addition, results of the REGROUP trial are consistent with a large observational Medicare CABG study that demonstrated no long-term major adverse cardiac outcomes in endoscopic versus open vein-graft harvest. Investigators do, however, encourage further studies to establish standards for harvester expertise that ensures patient safety and effective procedure.
Updated June 2019
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