Ringleb P A, Allenberg J, Brückmann H, Eckstein H-H, Fraedrich G, Hartmann M, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Stingele R, Zeumer H, Hacke W
Lancet. 2006 Oct 7;368(9543):1239-47. doi: 10.1016/S0140-6736(06)69122-8.
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.
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.
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.
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.
对于有严重症状性颈动脉狭窄的患者，颈动脉内膜切除术在预防中风方面是有效的，而颈动脉支架置入术已被广泛用作替代治疗方法。由于尚未令人信服地证明两种治疗方法具有等效性或优越性，我们旨在对两者进行比较。
1200例有症状性颈动脉狭窄的患者在短暂性脑缺血发作或中度中风（改良Rankin量表评分≤3）后的180天内被随机分配接受颈动脉支架置入术（n = 605）或颈动脉内膜切除术（n = 595）。这项基于医院的研究的主要终点是从随机分组到术后30天的同侧缺血性中风或死亡。基于5%的预期事件发生率，非劣效性界限被定义为小于2.5%。分析采用意向性分析。该试验在当前对照试验中注册，国际标准随机对照试验编号为ISRCTN57874028。
1183例患者纳入分析。从随机分组到术后30天，颈动脉支架置入术组的死亡或同侧缺血性中风发生率为6.84%，颈动脉内膜切除术组为6.34%（绝对差异0.51%，90%CI -1.89%至2.91%）。非劣效性的单侧p值为0.09。
SPACE研究未能证明颈动脉支架置入术与颈动脉内膜切除术相比在围手术期并发症发生率方面具有非劣效性。该试验结果无法证明在短期内广泛使用颈动脉支架置入术治疗颈动脉狭窄是合理的。有待观察6 - 24个月时的结果。
