Fast track — ArticlesEndarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial
Introduction
Large randomised clinical trials1, 2, 3 have established carotid surgery as the standard treatment for symptomatic severe carotid artery stenosis. Carotid stenting is an alternative treatment to carotid endarterectomy but whether stenting is as safe as surgery is and whether it provides long-term protection against stroke that is similar to that of surgery are unclear, although several trials have tried to, or aim to, answer these questions.4, 5 One such study, the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial,6, 7 was terminated early because of a higher 30-day risk of stroke or death in the stenting group.7 We now report the results of the EVA-3S trial up to 4 years.
Section snippets
Patients
This multicentre, randomised, open, assessor-blinded, non-inferiority trial was approved by the ethics committee of Cochin Hospital (Paris, France). All patients gave written, informed consent. The study started in November, 2000, and was done at 30 centres in France. In September, 2005, the safety committee recommended that enrolment in the trial stop for reasons of safety and futility.7 At that time, 527 patients had been enrolled.
The methods have been reported previously.6, 7, 8 Patients
Results
Of the 527 patients who were randomised, seven did not have carotid revascularisation. Two patients randomised to endarterectomy had stenting, and one patient assigned to stenting had endarterectomy. Stenting was converted intraoperatively to endarterectomy in 13 patients owing to problems with access. Three strokes occurred between randomisation and treatment (one in the endarterectomy group and two in the stenting group). All but three patients were followed up to death or to the end of the
Discussion
In this randomised study of patients with symptomatic carotid stenosis, the 4-year estimated cumulative risks of periprocedural stroke or death and non-procedural ipsilateral stroke were significantly higher after stenting than after endarterectomy. This difference was largely accounted for by the higher periprocedural risk of stenting compared with endarterectomy, whereas the risk of ipsilateral stroke beyond the perioperative period was low and similar in both groups. There was no difference
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2022, Journal of Vascular SurgeryCitation Excerpt :Although CEA remains the standard treatment for extracranial carotid stenosis, revascularization via stenting offers an alternative solution for high-risk surgical candidates. The investigation into a safe and equally effective, if not superior, minimally invasive carotid intervention has led to many randomized studies including the Carotid Revascularization with Endarterectomy vs Stenting Trial (CREST) in the United States,5 the International Carotid Stenting Study (ICSS)6,7 in Europe, the Endartérectomie Versus Angioplastie chez les patients avant une Sténose carotid Symptomatique Serrée (EVA-3S) in France,8 and Stent-protected Percutaneous Angioplasty of the Carotid vs Endarterectomy (SPACE)9,10 in Germany and Austria to compare CEA and carotid artery stenting outcomes in standard-risk patients. Significant findings from the CREST trial demonstrated higher peri-procedural (30-day) stroke risk after transfemoral carotid artery stenting (TFCAS) (4.1% ± 0.6% vs 2.3% ± 0.4%) and a higher risk of peri-procedural MI after CEA (2.3% ± 0.4% vs 1.1% ± 0.3%) despite no differences in composite stroke/death/MI endpoint.
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