WEDNESDAY, May 26, 2010 (HealthDay News) -- The latest major trial pitting invasive surgery against less invasive stenting to help prevent stroke shows that each is a safe, effective option.
Researchers report in the May 26 online edition of the New England Journal of Medicine that the study, which involved more than 2,500 patients treated at 117 centers across North America between 2000 and 2008, sought to determine if surgery to remove plaque from the carotid artery (running up the neck to the brain) was better or worse than the placement of an artery-opening stent. Blockages in the carotid artery are a major cause of stroke.
Other large trials have compared the two techniques, but this study was unique, the authors say, because half of the patients had symptoms of heart disease in the carotid artery, while the other half were symptom-free. That's important, the team said, because about half of the more than 140,000 carotid procedures performed in the United States annually occur in patients who have not yet developed symptoms.
After a median follow-up of 2.5 years, the team found no significant difference in rates of stroke, heart attack or death for patients receiving surgery versus stents. Overall, 7.2 percent of patients receiving stents went on to experience stroke, heart attack or death, compared to 6.8 percent of those undergoing the artery-clearing surgery.
The study found "excellent safety and long-term results for patients with warning signs for stroke as well as for patients without such warning signs," the study's national principal investigator, Dr. Thomas G. Brott, a professor of neurology and director for research at the Mayo Clinic in Jacksonville, Fla., said in a Mayo news release.
There were some key differences between the two procedures based on the type of patient, however. For example, for patients already exhibiting symptoms of carotid disease, estimated four-year rates of stroke and death was 8 percent if they underwent stenting, but just 6.4 percent if they had the surgery. Among those who did not have symptoms, the rate was 4.5 percent versus 2.7 percent, respectively.
People who underwent stenting had a slightly higher odds for death in the weeks following the procedure compared to those who underwent surgery (0.7 percent versus 0.3 percent), and they also had a higher risk for stroke during the weeks after the procedure. However, the odds for heart attack during this time period were less for those undergoing stenting (1.1 percent) versus surgery (2.3 percent), the team said. Rates for recurrent stroke were low among both groups (between 2 percent and 3 percent).
Based on the findings, "we now have two safe and effective methods to treat carotid artery disease that can be targeted to individual patients," Mayo Clinic neurologist and study co-author Dr. James Meschia said in the news release.
"As outcomes continue to improve, so does the opportunity for stroke prevention in an expanding number of patients," added co-principal investigator for stenting Dr. Gary Roubin, chairman of the department of cardiovascular medicine at Lenox Hill Hospital in New York City. "The potential now exists for a less invasive, less expensive outpatient approach to treating carotid stenosis," he said in a hospital news release.
In their editorial in the journal, Drs. Stephen M. Davis and Geoffrey A. Donnan of the University of Melbourne, Australia, said that while the results are promising, "more long-term data are needed before a full appreciation of the relative risks and benefits of the two procedures can be made." In the meantime, they say, decisions may best be made on a case-by-case basis and "the individualization of treatment choices is appropriate."
Learn the warning signs of stroke at the American Heart Association.