Elsevier

The Lancet Neurology

Volume 7, Issue 10, October 2008, Pages 885-892
The Lancet Neurology

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Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial

https://doi.org/10.1016/S1474-4422(08)70195-9Get rights and content

Summary

Background

Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years.

Methods

In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov, number NCT00190398.

Findings

262 patients were randomly assigned to endarterectomy and 265 to stenting. The cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke after 4 years of follow-up was higher with stenting than with endarterectomy (11·1% vs 6·2%, hazard ratio [HR] 1·97, 95% CI 1·06–3·67; p=0·03). The HR for periprocedural disabling stroke or death and non-procedural fatal or disabling ipsilateral stroke was 2·00 (0·75–5·33; p=0·17). A hazard function analysis showed the 4-year differences in the cumulative probabilities of outcomes between stenting and endarterectomy were largely accounted for by the higher periprocedural (within 30 days of the procedure) risk of stenting compared with endarterectomy. After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups. For any stroke or periprocedural death, the HR was 1·77 (1·03–3·02; p=0·04). For any stroke or death, the HR was 1·39 (0·96–2·00; p=0·08).

Interpretation

The results of this study suggest that carotid stenting is as effective as carotid endarterectomy for middle-term prevention of ipsilateral stroke, but the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy in patients with symptomatic carotid stenosis.

Funding

French Ministry of Health.

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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