Three-year follow-up of study shows similar results
WEDNESDAY, April 9 (HealthDay News) -- Carotid stenting -- inserting a tube into the main artery to the brain to prevent a stroke -- is as effective over the long term for high-risk patients as a surgery called endarterectomy, a study shows.
But endarterectomy -- the removal of plaque from the artery -- will continue to be the treatment of choice for the 70 percent to 80 percent of the patients who are not classified as high-risk, the experts say.
"Surgery has been around for 50 years," said Dr. Hitinder S. Gurm, an assistant professor of medicine at the University of Michigan and lead author of a report in the April 10 issue of the New England Journal of Medicine. "It's better to go with something you know more about," he reasoned.
The report described a three-year follow-up of a study that compared stenting with endarterectomy in 334 people who had narrowing of the carotid artery and were at high risk of complications from surgery. Data on 260 of the participants showed that the incidence of heart attacks, strokes and death was about the same in the two groups, occurring in 24.6 percent of those who were stented and 26.9 percent of those who had surgery.
The study was funded by Cordis Corp., a unit of the pharmaceutical company Johnson & Johnson, which markets stents. The company had no role in data analysis, the researchers said.
Participants were at high risk because of the location of the potential blockage (either very high or very low in the carotid artery); because they had radiation therapy; or because they had undergone a previous endarterectomy, Gurm said. Someone with very serious heart or lung disease might also be at risk from surgery, he said.
It's not yet possible to extend those results to people who are not at high risk, said study senior author Dr. Donald E. Cutlip, an associate professor of medicine at Harvard Medical School.
"You can't answer that question on the basis of our study," Cutlip said. "What we can say is that the results are similar in high-risk patients at one-year and now at three-year outcomes."
The real answer probably will come from an ongoing major government-funded study of several thousand low- and moderate-risk participants, Gurm and Cutlip said. Results from that effort are expected in "two to three years," Gurm said.
"Also, there are several registries from randomized studies that are going on," Cutlip said. "Their results might sway opinion."
In the meantime, most people who have a carotid artery procedure at a community hospital rather than a specialized center will continue to have surgery, agreed Dr. Deepak Bhatt, associate director of the Cleveland Clinic's Cardiovascular Coordinating Center.
At least one study has shown that carotid stenting can be done as effectively by community physicians as by specialists. And it is possible for someone who needs a procedure and would prefer stenting to have it done in the name of research, by enrolling in a trial comparing the two procedures, Bhatt said.
"If you don't really want surgery you can have a stent, but under the umbrella of research, where you are followed closely," he said.
The various carotid artery procedures are described by the Cleveland Clinic.
SOURCES: Hitinder S. Gurm, M.D., assistant professor, medicine, University of Michigan, Ann Arbor; Donald E. Cutlip, M.D., associate professor, medicine, Harvard Medical School; Deepak Bhatt, M.D., associate director, Cleveland Clinic Cardiovascular Coordinating Center; April 10, 2008, New England Journal of Medicine
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