Carotid Stenting Not as Effective as Carotid Endarterectomy
FORT LAUDERDALE, Fla. -- Carotid stenting in which a metal mesh tube is inserted into the main neck artery feeding the brain is less effective than surgery as a treatment for carotid blockages that can lead to stroke, a Duke University Medical Center neurologist reported Thursday.
In the first prospective, randomized, multi-center trial examining use of stents and surgery called carotid endarterectomy, the difference in outcomes between the two therapies was so significant that the study was halted early.
Carotid endarterectomy (CEA) has been used for years to prevent possible strokes due to blockages in the carotid arteries that supply blood to the brain. CEA is a procedure in which surgeons make an incision in the neck, identify and split the carotid artery lengthwise, remove the plaque causing the blockage, and sew the artery back together.
Stenting, a newer treatment option, has been considered to have potential advantages such as being less invasive, having fewer complications and a faster recovery rate, and a good option for patients who are not candidates for surgery. In this study, stenting involved inserting a catheter into the artery to open the blockage, and then supporting the newly widened artery with the metal mesh tube called a stent.
Until now, the potential advantages of carotid stenting to surgery were largely theoretical. This is the first study to examine how stenting compares to surgery.
Dr. Mark Alberts, a Duke neurologist and investigator with the WALLSTENT study, prepared the findings for presentation Thursday at the American Heart Association's annual stroke conference.
"After enrolling 221 patients, we were able to determine the stent group was doing significantly worse than the surgical group," Alberts said. "The primary endpoint for the study was ipsilateral stroke, vascular death, or study-related death at the end of one year. After one year of follow-up, we found the rate of stroke or death to be 12 percent for the stent group and 3.5 percent in the surgical group."
To participate as a study site, each of the 29 medical centers involved had to have a track record of being able to place stents without a high complication rate, as well as have a team of surgeons who could perform CEA with a complication rate of 6 percent or less. Additionally, each center was required to have a multidisciplinary team comprised of neurologists, surgeons and interventionalists who would evaluate each patient thoroughly before and after enrollment. Patients had to have 60 percent to 99 percent symptomatic blockages in order to qualify for enrollment.
"Many people look at stenting as a good treatment option without really knowing if it is a good thing to do or not a good thing to do," said Alberts. "We needed data from a scientifically rigorous study to prove one way or another which is the better treatment option. Now we have that data and it shows that stenting is not as good as endarterectomy."
Stroke is the third-leading cause of death in the United States and is a major cause of serious, long-term disability, according to the American Stroke Association.
Stents have received wide acclaim in the treatment of coronary artery disease because of their success rate in increasing blood flow to the heart, reducing chest pain, and relatively low complication rate. Due to the success rate of stents, researchers began considering them as a potential treatment for carotid artery disease, a risk factor in stroke.
Researchers had intended to enroll as many as 700 patients in the WALLSTENT study, but halted the study in June 1999 after data showed endarterectomy was clearly more effective. The study was funded by Schneider Inc. and Boston Scientific Corporation.