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