PHILADELPHIA — The periprocedural rate of death or stroke in patients undergoing carotid artery stenting was about 40% higher than for similar patients who had a carotid endarterectomy, on the basis of a metaanalysis that included data from seven trials with nearly 3,000 patients.
This is the first statistically significant difference seen in serious adverse events during the first 30 days following treatment with these two alternatives for managing clinically significant carotid stenosis. The new analysis included recently reported results from two European studies, which together doubled the number of patients available for the combined analysis, Dr. Hans-Henning Eckstein said at the Vascular Annual Meeting.
He cautioned that the finding was from a preliminary analysis that included as-yet unpublished data.
In addition, “we have to wait for at least 2 years, and even better would be to wait for 3, 4, or 5 years to look at stroke prevention” by the two interventions, said Dr. Eckstein, head of the division of vascular surgery at the Technical University of Munich. But, he added, the new metaanalysis and its focus on the rate of 30-day death or stroke is useful for helping patients select the type of carotid intervention they would prefer.
Until this spring, five reported studies had compared carotid artery stenting with endarterectomy in randomized, controlled trials. These five studies involved a total of 1,269 patients, and a metaanalysis published about a year ago, showed that the incidence of any stroke or death during the first 30 days was 33% higher in patients treated with stenting, compared with those who had endarterectomy (Stroke 2005;36:905–11). But this difference did not reach statistical significance.
One of the new studies, the Stent-Protected Percutaneous Angioplasty of the Carotid vs. Endarterectomy (SPACE) trial, included 1,183 patients, who were treated at any of 37 medical centers in Germany, Austria, or Switzerland.
All of the SPACE patients were symptomatic (with amaurosis fugax, a transient ischemic attack, or a stroke within the previous 180 days) and also had at least 50% stenosis in their carotid artery based on the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET).
Patients who were randomized to stenting could be treated with any of three different carotid stents: the Acculink, the Precise, or the Wallstent. Treatment with an embolic-protection device was optional, and was used on about a third of the patients. The outcomes of the patients treated with embolic-protection devices were no different from those in whom no device was used. The study was primarily sponsored by the German Ministry of Science, but it also received support from Guidant Corp., which markets the Acculink stents, and from Boston Scientific Corp., which markets the Wallstent.
The periprocedural rate of death or stroke was 6.84% in the patients treated with carotid stenting and 6.34% in those treated with endarterectomy—a nonsignificant difference Dr. Eckstein reported.
Results from a similarly designed French study were reported in mid-May at the European Stroke Conference in Brussels. The Endarterectomy vs. Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) study enrolled 520 patients. The 30-day rate of death or stroke was 9.6% in 261 patients treated with carotid stenting and 3.9% in those treated with endarterectomy.
When the results of both the SPACE and EVA-3S trials were added to the previously reported metaanalysis results, the overall numbers showed an 8.2% periprocedural death or stroke rate among 1,492 patients treated with stenting, and a 5.9% rate among 1,480 patients treated with endarterectomy, a significant difference.
“I'm sure there will be a place for carotid stenting in the future,” but randomized, controlled trials against endarterectomy must be done to determine its proper role, Dr. Eckstein said.
In addition, there may now be enough experience in the metaanalysis database to run stratified analyses and identify which subgroups of patients did best. The experience and technique of the operators will also be an important factor. In the multicenter results that Dr. Eckstein reported, there was a clear difference in outcomes among the centers; one hospital had a perioperative event rate of more than 20%.