REGROUP trial: Major adverse cardiac events results similar for endoscopic vein harvesting compared to open vein harvesting for CABG

There were no significant differences in major adverse cardiac events for endoscopic vein harvesting compared to open vein harvesting for CABG, according to Randomized Endovein Graft Prospective (REGROUP) results presented at Scientific Sessions 2018 in Chicago.

In the intent-to-treat, two-arm, parallel design, multicenter study, 1,150 people in 16 Veterans Health Administration centers were randomized to endoscopic vein harvesting or open (non-endoscopic) vein harvesting, with a median follow-up of 2.78 years.

Of the two surgical methods for CABG, “endoscopic vein harvesting is minimally invasive and only requires a small incision,” said Marco Zenati, MD, MSc, professor of surgery at Harvard Medical School in Cambridge, Massachusetts. “But from the provider, it requires a steep learning curve to become an expert.”

In REGROUP, the harvesting operation needed to be done on pump on the arrested heart, “and, crucially, the endoscopic harvest had to be performed by an expert, with excess of 100 EVH cases,” Zenati said.
The trial had to be large enough for a meaningful primary outcome of major adverse cardiac events: a composite of all-cause mortality, non-fatal myocardial infarction or repeat revascularization, Zenati said. Off-pump CABG patients were excluded. The characteristics of patients were balanced in both study arms.

The rates of major adverse cardiac events for endoscopic versus open harvest were 13.9 percent vs. 15.5 percent, P=0.47, primary outcome, with fewer leg wound healing problems associated with the minimally invasive method.

“We also saw a trend toward fewer recurrent events after the endoscopic approach,” said Zenati, who is also chief of cardiothoracic surgery at Boston Healthcare System and associate surgeon at Brigham and Women’s Hospital.

Longer-term follow-up and additional studies that include graft patency data are needed, he said.

Further studies are needed to establish standards for harvester expertise to ensure the safety of patients and effectiveness of the procedure.