SPACE
(2008)Objective
Stent-protected angioplasty versus CEA in patients with symptomatic carotid stenosis.
Study Summary
• SPACE failed to prove non-inferiority of carotid artery stenting (CAS) compared with carotid endarterectomy (CEA) for the 30-day rate of ipsilateral ischaemic stroke or death in symptomatic patients with severe carotid stenosis. • At 2-year follow-up, the rate of ipsilateral stroke was similar between both groups, but recurrent stenosis was significantly higher in the CAS group.
Intervention
Carotid artery stenting (CAS) vs. Carotid endarterectomy (CEA).
Inclusion Criteria
Patients with symptomatic severe carotid stenosis (>70%) eligible for carotid revascularization.
Study Design
Arms: CAS vs. CEA
Patients per Arm: 1200 randomized: CAS n=605, CEA n=595; 1183 included in the analysis.
Outcome
• Primary endpoint (30 days): ipsilateral ischaemic stroke or death from randomisation to 30 days after procedure: 6.84% in CAS vs 6.34% in CEA; absolute difference 0.51% (90% CI -1.89% to 2.91%); one-sided P=0.09 for non-inferiority (non-inferiority not proven). <br>• At 2-year follow-up: ipsilateral stroke rate 9.5% in CAS vs 8.8% in CEA (P=0.62); recurrent stenosis 10.7% in CAS vs. 4.6% in CEA (P=0.0009).