May 21, 2008 (Nice, France) — Long-term results from 2 large European trials suggest that carotid artery stenting (CAS) is as effective as carotid endarterectomy (CEA) in preventing recurrent ischemic stroke in patients with severe, symptomatic carotid stenosis.
Presented here at the 17th European Stroke Conference (ESC), results from both the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-S3) and the Stent-Protected Percutaneous Angioplasty of the Carotid Artery vs Endarterectomy (SPACE) studies reported strikingly similar results in terms of the long-term efficacy of the 2 procedures, despite the fact that in both studies, stenting had failed to meet noninferiority criteria vs endarterectomy in their primary analyses.
"The conclusion from the SPACE trial is exactly the same as the EVA-S3 study. That is, if a patient has been treated successfully without any complications, the [long-term] risk of a secondary stroke is very small and very comparable between these 2 modalities," Peter A. Ringleb, MD, from Ruprecht-Karls-University, in Heidelberg, Germany, principal investigator of the SPACE study, told reporters attending an ESC press conference.
SPACE Results
Launched in 2001, the SPACE study is a randomized noninferiority trial that included 1214 patients from 37 centers in Germany, Switzerland, and Austria.
The goal of the study was to determine whether safety and efficacy of treatment for symptomatic carotid stenosis with CAS was equivalent to the standard approach of CEA.
The 30-day outcome results, which were published in 2006, failed to demonstrate noninferiority of the stenting procedure vs endarterectomy.
Here at the ESC, where the 2-year follow-up results were presented for the first time, the investigators found the rate of any periprocedural stroke or death, plus ipsilateral ischemic stroke within 2 years, was very similar, at 8.49% in the CEA group and 9.22% in the CAS group.
Furthermore, the investigators reported the absolute number of recurrent ischemic events after the periprocedural period at 2-year follow-up was low — 10 events after CEA (1.7%) and 12 after CAS (2.0%).
Need for Improvement
The EVA-S3 trial was also a randomized noninferiority study that was conducted at 30 centers in France and included 527 subjects. Launched in 2000, the study was stopped by the safety committee in 2005 due to a higher 30-day risk of stroke or death associated with stenting.
In 2006, within a week of the SPACE investigators publishing their findings, the EVA-3S researchers reported that the 30-day risk of any stroke was significantly greater for stenting — 9.6% for CAS vs 3.9% CEA. For disabling stroke, the rate at 30 days was 3.4% for stenting compared with 1.5% for endarterectomy.
However, the investigators continued to follow study subjects and found the rates of ipsilateral stroke from 31 days to 4 years were very low in both groups — 11.1% for CAS and 6.2% for CEA — a difference that was not statistically significant, said the study's principal investigator, Jean-Louis Mas, MD, from the Hôpital Sainte-Anne, in Paris, France.
"Carotid stenting is as effective as carotid endarterectomy in preventing further ischemic stroke, but we need to improve the safety of the technique before it can become a widespread alternative to carotid endarterectomy in patients with symptomatic carotid stenosis," said Dr. Mas.
17th European Stroke Conference: Abstracts 4 and 5. Presented May 14, 2008.
Drs. Mas and Ringleb report no conflicts of interest. The EVA-S3 study was supported by the French Department of Health. The SPACE study was supported by the Germany's Federal Ministry of Education and Research, German Research Foundation, German Neurological Society, German Neuroradiological Society, Deutsche Röntgengesellescahft, Guidant, Boston Scientific, and Sanofi-Aventis.
