Elsevier

The Lancet Neurology

Volume 7, Issue 10, October 2008, Pages 893-902
The Lancet Neurology

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Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial

https://doi.org/10.1016/S1474-4422(08)70196-0Get rights and content

Summary

Background

The SPACE trial is a multinational, prospective, randomised study to test the hypothesis that carotid artery stenting is not inferior to carotid endarterectomy for treating patients with severe symptomatic carotid artery stenosis. We did not prove non-inferiority of carotid artery stenting compared with carotid endarterectomy for the 30-day complication rate, and we now report the results at 2 years.

Methods

Between March, 2001, and February, 2006, patients with symptomatic, severe (≥70%) carotid artery stenosis were recruited to this non-inferiority trial and randomly assigned with a block randomisation design to have carotid artery angioplasty with stenting or carotid artery endarterectomy. 2-year endpoints include several clinical endpoints and the incidence of recurrent carotid stenosis of at least 70%. Clinical and vascular follow-up was done by a certified neurologist. Analyes were by intention to treat and per protocol. This trial is registered with ISRCTN, number 57874028.12.

Findings

1 214 patients were randomly assigned (613 were randomly assigned to carotid angioplasty with stenting and 601 were randomly assigned to carotid endarterectomy). In both the intention-to-treat and per-protocol analyses the Kaplan-Meier estimates of ipsilateral ischaemic strokes up to 2 years after the procedure and any periprocedural stroke or death do not differ between the carotid artery stenting and the carotid endarterectomy groups (intention to treat 9·5% vs 8·8%; hazard ratio (HR) 1·10, 95%CI 0·75 to 1·61; log-rank p=0·62; per protocol 9·4% vs 7·8%; HR 1·23, 95%CI 0·82 to 1·83; log-rank p=0·31). In both the intention-to-treat and per-protocol populations, recurrent stenosis of 70% or more is significantly more frequent in the carotid artery stenting group compared with the carotid endarterectomy group, with a life-table estimate of 10·7% versus 4·6% (p=0·0009) and 11·1% versus 4·6% (p=0·0007), respectively. Only two incidences of recurrent stenoses after carotid artery stenting led to neurological symptoms.

Interpretation

After 2 years' follow-up, the rate of recurrent ipsilateral ischaemic strokes reported in the SPACE trial is similar for both treatment groups. The incidence of recurrent carotid stenosis at 2 years, as defined by ultrasound, is significantly higher after carotid artery stenting. However, it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.

Funding

Federal Ministry of Education and Research; German Research Foundation; The German Society of Neurology; The German Society of Neuroradiology; The German Radiological Society; Boston Scientific; Guidant; Sanofi-Aventis.

Introduction

On the basis of prospective randomised trials, carotid endarterectomy is effective for preventing stroke in patients with severe symptomatic carotid artery stenosis.1, 2 Carotid artery stenting might be an alternative treatment to carotid endarterectomy but whether or not this procedure is as safe and effective as carotid endarterectomy is unknown. Early outcome data from two large, European, randomised, multicentre trials were published in 2006.3, 4 The French Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial was stopped early after recruitment of 527 patients, owing to a significantly lower rate of stroke or death in the patients who were treated surgically. The Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) trial investigators failed to prove non-inferiority of carotid artery stenting compared with carotid endarterectomy for rates of ipsilateral stroke and death within 30 days. Here, we report the final results of SPACE at 30 days and at 2 years.

Section snippets

Patients

Patients with symptomatic severe carotid artery stenosis (≥70% according to the ECST study1) in the previous 6 months were randomly assigned to carotid endarterectomy or carotid artery stenting if surgeons and interventionalists confirmed that treatment would be possible. The inclusion and exclusion criteria have been published in detail elsewhere.5 All patients provided written informed consent before randomisation.

Procedures

This multinational, prospective, randomised trial was designed to test the

Results

1214 patients were randomised: 601 to carotid endarterectomy and 613 to carotid stenting. Figure 1 shows the trial profile. 18 patients (6 in the stenting group and 12 in the endarterectomy group) were excluded from the statistical analysis because they withdrew their consent between randomisation and treatment. There was no difference in baseline variables between the two treatment groups for the overall population (table 1). The rates of primary endpoint events after 30 days in the

Discussion

The SPACE trial investigators failed to prove the non-inferiority of carotid angioplasty with stenting compared with carotid endarterectomy for 30-day complication rates. For most 30-day endpoints, surgery was the more favourable option. However, we found no differences between carotid endarterectomy and carotid angioplasty with stenting with respect to the prevention of recurrent cerebrovascular events after treatment of severe symptomatic carotid artery stenosis at 2 years. Few clinical

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