A new analysis of phase III trial data shows that carotid stenting and carotid endarterectomy produce similar three-year outcomes for high-risk patients, according to an article in the April 10 issue of the New England Journal of Medicine.

After three years, patients in the SAPPHIRE trial who had the minimally-invasive procedure had statistically similar rates of adverse events including stroke, myocardial infarction, and death compared with the rates for patients who underwent open surgery.

The findings should help guide the treatment of patients who need to have one of the two carotid arteries in their necks un-clogged to reduce their risk of a stroke - but who face a high risk of complications during surgery because of other health issues. Such patients may do better with the minimally invasive option, called carotid stenting.

The results were drawn from 260 patients who were randomized to one of the two treatments at 29 hospitals; the study was conducted by researchers at several institutions including the University of Michigan Cardiovascular Center and Harvard University.

"Patients who are undergoing a procedure want to know that they'll be protected long-term from stroke and that the procedure is safe," said lead author Hitinder Gurm, MD. "This is the first study to suggest that stents do just as well long-term as surgery in high-risk patients."

The study's senior and corresponding author was Donald Cutlip, MD, executive director of clinical investigations at Harvard University's Clinical Research Institute. SAPPHIRE was led by Jay Yadav, MD, formerly at the Cleveland Clinic and now at Piedmont Hospital in Atlanta.

In all, 41 of 143 patients (28 percent) who underwent stenting and 45 of 117 patients (38 percent) who underwent endarterectomy had myocardial infarction, stroke, or death within three years. The two rates were statistically equivalent, showing no difference between the two treatments. About a third of adverse events were strokes, most of them minor. Stenting procedures included use of embolic protection devices.

Eligible patients were considered high risk based on criteria including presence of heart failure or pulmonary disease, history of neck surgery or radiation therapy, age over 80 years, or a history of carotid artery treatment followed by restenosis.

In the SAPPHIRE study, patients who had symptoms such as transient ischemic attacks, stroke, or dizziness could participate if a carotid artery had stenosis of 50 percent or greater. However, patients without symptoms could only participate if they had stenosis of 80 percent or more that had been discovered through an imaging exam such as ultrasound.

In all, three-year data was available on 260 of the 334 patients who were randomized assigned to one of the two treatments at the beginning of the study. Previous analyses of SAPPHIRE data have shown no difference between the two treatment groups after 30 days and one year. The main measure to compare the two treatments was a combination of stroke, myocardial infarction or death from any cause, although each type of incident was also analyzed.

"Clinical trials are now under way to determine the relative risks and benefits of stenting and endarterectomy in average-surgical-risk patients, and to compare different stent procedures," said Gurm, an assistant professor of internal medicine at the U-M Medical School and the VA Ann Arbor Healthcare Center. He noted that two such trials are under way at U-M. "Outside of trials, I do not think a person with average surgical risk should undergo stenting. But for high-risk patients, we can now be certain that they will have a similar long-term outcome from stenting as they would have had from surgery."