In the hands of experts, there was no difference in rates of major adverse cardiac events with endoscopic vs open vein-graft harvesting nearly 3 years after on-pump coronary artery bypass surgery (CABG) in the Randomized Endo-Vein Graft Prospective ( REGROUP) trial. The study was published simultaneously in the New England Journal of Medicine.
The primary endpoint of death, myocardial infarction (MI), or revascularization occurred in 13.9% of patients with endoscopic vein harvesting (EVH) and in 15.5% of patients with open vein harvesting (OVH) at a medium follow-up of 2.78 years ( hazard ratio [HR], 1.12, 95% confidence interval [CI], 0.83 – 1.51, P = .47).
Rates were lower with EVH for the individual components of death (6.4% vs 8%), MI (4.7% vs 5.9%), and revascularization (5.4% vs 6.1%). As expected, patients also experienced fewer harvest sites.
"Endoscopic harvest performed by an expert may be considered the preferred vein harvesting modality," Marco Zenati, MD, Veterans Affairs Boston Healthcare System and Harvard Medical School, said here at the American Heart Association (AHA) Scientific Sessions 2018.
REGROUP mortality rate
Although the use of arterial conduits has steadily increased, saphenous vein grafts are used in as many as 90% of CABG in North America. Decreased patency and a higher death rate in the observational PREVENT IV trial, however, raised safety concerns about the EVH technique. REGROUP showed that EVH is as good as OVH for the prevention of MACE. Moreover, the study had a few sources of bias and a commendably high randomized to screening ratio of more than 1 to 3, he said.
Moreover, the study lacked histologic and patency data. "Patency is assumed to be good in this trial, but it's not impossible that it could be across the board," said Ruel, who pointed out similarities between the REGROUP mortality rate and the 4-year mortality rate in the EXCEL trial .
During the discussion, Zenati said they had agonized over the issue of graft patency during the planning phase but were followed by the experience of several trials, including ROOBY , in which fewer than 60% of patients were returned for angiography at 1 year.
Zenati replied, "We were actually able to determine the difference; and we also wanted to say these patients had a compliance that was approaching 90% at 2 years with triple guideline-directed medical therapy.; and I also want to say these patients had a compliance that was approaching 90% at 2 years with triple guideline-directed medical therapy. So we are confident."
This prompted session as a timer Timothy Gardner, University of Pennsylvania, Philadelphia, to comment, "I think this study takes the cloud away from the endoscopic vein harvest that the PREVENT trial had cast."comoderator Timothy Gardner, University of Pennsylvania, Philadelphia, to comment, "I think this study takes the cloud away from the endoscopic vein harvest that the PREVENT trial had cast."
EVH is known to have a steep learning curve, and one of the criticisms of PREVENT IV is that it allowed less experienced endoscopic vein-graft harvesters to participate. As a result, REGROUP required EVH harvesting expertise, defined as having an excess of 100 EVH procedures with less than a 5% rate of conversion to open surgery within an EVH program that had been established for more than 2 years.
A total of 1150 patients at 16 VA cardiac surgery centers were randomly assigned to EVH or OVH. Their mean age was 66 years, the mean Society of Thoracic Surgery PROM score was 0.94%, and the mean SYNTAX score was 28.5.
There was a trend for fewer Also recurrent major cardiac events with the endoscopic approach (HR 1.29; 95% CI, 1.00 – 1.68), Zenati said. In Addition to the lack of graft patency imaging, I have other limitations Said Were the male population predominantly, exclusion of off-pump CABG, and participation of only expert harvesters.
"So we're still going to be harvesting a lot of vein grafts, and my patients in the past who had the full zipper on their leg, had a tough time for ambulating, worse outcomes, more infections, and more complaints," he said. "So this endoscopic approach to the foreseeable future is very much here to stay and much better than the full open approach."