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[ Stent and surgery for symptomatic carotid stenosis . SPACE study results ] . The SPACE trial compared risk and effectiveness of stent-supported angioplasty ( CAS ) vs carotid endarterectomy ( CEA ) using a noninferiority design in patients with symptomatic stenoses . Intention-to-treat analysis of the entire study population of 1,214 patients showed that primary endpoint events ( ipsilateral stroke or death between randomisation and day 30 ) occurred in 6.92 % of the CAS group and 6.45 % of the CEA group . The 95 % confidence interval ( CI ) of the absolute risk difference ranged from -1.94 % to +2.87 % , therefore the noninferiority was not proven . The same was true for the analysis of protocols . No significant differences between the two treatment methods were found in primary or any of the secondary endpoints . There were also no differences in short-term prevention . The endpoint 'ipsilateral ischemic stroke or vascular death between randomisation and 6 months ' occurred in 7.4 % of the CAS and 6.5 % of the CEA patients ( odds ratio 1.16 , 95 % confidence interval 0.74-1.82 ) . Instent restenoses were significantly more common in the CAS group ( 4.6 % vs 2.2 % , odds ratio 2.14 , 95 % CI 1.10-4.18 ) . Surgery remains the gold standard in treatment of patients with symptomatic carotid artery stenosis . Stent-supported angioplasty can be an alternative only in the hands of an experienced interventionalist with proven low periprocedural complication rate .
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Intervention_Surgical
Stent and surgery
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Intervention_Surgical
stent-supported angioplasty ( CAS )
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Intervention_Surgical
carotid endarterectomy ( CEA )
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Intervention_Surgical
CAS
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Intervention_Surgical
CEA
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Intervention_Surgical
CAS
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Intervention_Surgical
CEA
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Intervention_Surgical
CAS
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Intervention_Surgical
Stent-supported angioplasty
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Outcome_Other
absolute risk difference
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Outcome_Other
short-term prevention
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Outcome_Physical
'ipsilateral ischemic stroke or vascular death between randomisation and 6 months
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Outcome_Physical
Instent restenoses
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Outcome_Adverse-effects
periprocedural complication rate