Researchers found no significant difference in long-term outcomes between patients who underwent carotid artery stenting with embolic protection and those who underwent endarterectomy, according to SAPPHIRE trial results published in the April 10 issue of the New England Journal of Medicine.
Hitinder S. Gurm, MD, director of carotid interventions in cardiovascular medicine at the University of Michigan School of Medicine in Ann Arbor, Mich., previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days, and at one year. The current results reflect the three-year results, he said.
The researchers reported that the trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50 percent of the luminal diameter, or an asymptomatic stenosis of at least 80 percent.
The investigators reported that the pre-specified major secondary end point at three years was a composite of death, stroke, or MI within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1,080 days (three years).
At three years, the researchers said that the data were available for 260 patients (77.8 percent), including 85.6 percent of patients in the stenting group and 70.1 percent of those in the endarterectomy group. The pre-specified major secondary end point occurred in 41 patients in the stenting group and 45 patients in the endarterectomy group (absolute difference in cumulative incidence for the stenting group, –2.3 percent), the authors wrote.
There were 15 strokes in each of the two groups, of which 11 in the stenting group and nine in the endarterectomy group were ipsilateral, according to the researchers.
Gurm and colleagues noted that the patient population was chosen because of the desire to develop a less invasive but effective treatment for patients with a high surgical risk, who account for up to one-third of patients undergoing carotid endarterectomy.
“We could not demonstrate a significant difference between protected carotid artery stenting and carotid endarterectomy with respect to the risk of stroke or other major adverse events in our high-risk patients at three years. We also found no evidence of an increased risk of repeat revascularization within three years after treatment,” the researchers reported.
Cordis funded the trial, and had advisory input into the study design. The Miami Lakes, Fla.-based company also had representation on the executive committee.