30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients

• Titel: 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients
• Titelzusatz: a randomised non-inferiority trial
• Mitwirkende: Ringleb, Peter A.
• Mitwirkende: Allenberg, Jens-Rainer
• Mitwirkende: Hennerici, Michael G.
• Mitwirkende: Hacke, Werner
• Verf.angabe: the SPACE Collaborative Group
• E-Jahr: 2006
• Jahr: August 10, 2006
• Umfang: 9 S.
• Fussnoten: The SPACE Collaborative Group: P.A. Ringleb, J. Allenberg, H. Brückmann, H.-H. Eckstein, G. Fraedrich, M. Hartmann, M. Hennerici, O. Jansen, G. Klein, A. Kunze, P. Marx, K. Niederkorn, W. Schmiedt, L. Solymosi, R. Stingele, H. Zeumer, W. Hacke ; Gesehen am 30.06.2015
• Titel Quelle: In: The lancet
• Ort Quelle: London [u.a.] : Elsevier, 1823
• Jahr Quelle: 2006
• Band/Heft Quelle: 368(2006), 9543, Seite 1239-47
• ISSN Quelle: 1474-547X
• DOI: doi:10.1016/S0140-6736(06)69122-8
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1504659279

Abstract

BACKGROUND: Carotid endarterectomy is effective in stroke prevention for patients with severe symptomatic carotid-artery stenosis, and carotid-artery stenting has been widely used as alternative treatment. Since equivalence or superiority has not been convincingly shown for either treatment, we aimed to compare the two. - METHODS: 1200 patients with symptomatic carotid-artery stenosis were randomly assigned within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) carotid-artery stenting (n=605) or carotid endarterectomy (n=595). The primary endpoint of this hospital-based study was ipsilateral ischaemic stroke or death from time of randomisation to 30 days after the procedure. The non-inferiority margin was defined as less than 2.5% on the basis of an expected event rate of 5%. Analyses were on an intention-to-treat basis. This trial is registered at Current Controlled Trials with the international standard randomised controlled trial number ISRCTN57874028. - FINDINGS: 1183 patients were included in the analysis. The rate of death or ipsilateral ischaemic stroke from randomisation to 30 days after the procedure was 6.84% with carotid-artery stenting and 6.34% with carotid endarterectomy (absolute difference 0.51%, 90% CI -1.89% to 2.91%). The one-sided p value for non-inferiority is 0.09. - INTERPRETATION: SPACE failed to prove non-inferiority of carotid-artery stenting compared with carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses. Results at 6-24 months are awaited.