Fluri Felix, Engelter Stefan, Lyrer Philippe
Department of Neurology, University Hospital Basel, Petersgraben 4, Basel, Switzerland, 4031.
Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD005953. doi: 10.1002/14651858.CD005953.pub2.
The EC/IC Bypass Study Group found no benefit of extracranial to intracranial (EC/IC) bypass surgery over medical therapy in patients with symptomatic carotid artery occlusion (sCAO). However, the study was criticised for many reasons and the real effect of this treatment is still not known conclusively.
To determine whether bypass surgery plus medical care is superior to medical care alone in patients with sCAO.
We searched the Cochrane Stroke Group Trials Register (last searched June 2009). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to June 2009) and EMBASE (1980 to June 2009). We also searched ongoing trials and research registers, checked reference lists of relevant articles, and contacted colleagues, trial authors and researchers.
Randomised controlled trials (RCT) and non-random studies of EC/IC bypass surgery plus best medical treatment compared with best medical treatment alone to prevent subsequent stroke, improve cerebral haemodynamics and reduce dependency after stroke.
Two review authors independently selected studies for inclusion, and extracted data items on the number of outcome events onto a data extraction form. We only analysed secondary outcomes if the study provided information on at least one primary outcome. We also used intention-to-treat analysis where possible.
We included 21 trials, including two RCTs, involving 2591 patients. For all endpoints, no benefit of EC/IC bypass surgery was shown either in the RCTs (any death: odds ratio (OR) 0.81, 95% confidence interval (CI) 0.62 to 1.05, P = 0.11; stroke: OR 0.99, 95% CI 0.79 to 1.23, P = 0.91; death and dependency: OR 0.94, 95% CI 0.74 to 1.21, P = 0.64), or in the non-RCTs (any death: OR 1.00, 95% CI 0.62 to 1.62, P = 0.99; stroke: OR 0.80, 95% CI 0.54 to 1.18, P = 0.25; death and dependency: OR 0.80, 95% CI 0.50 to 1.29, P = 0.37).
AUTHORS' CONCLUSIONS: EC/IC bypass surgery in patients with sCAO disease was neither superior nor inferior to medical care alone. However, most studies included patients irrespective of their cerebral haemodynamics. Participation in an ongoing RCT, which is restricted to patients with impaired haemodynamics, is recommended as these patients might benefit from bypass surgery.
颅外-颅内(EC/IC)旁路手术研究组发现,对于有症状性颈动脉闭塞(sCAO)的患者,EC/IC旁路手术并不比药物治疗更具优势。然而,该研究因诸多原因受到批评,这种治疗的实际效果仍未最终明确。
确定在sCAO患者中,旁路手术联合药物治疗是否优于单纯药物治疗。
我们检索了Cochrane卒中组试验注册库(最后检索时间为2009年6月)。此外,我们还检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2006年第2期)、MEDLINE(1966年至2009年6月)和EMBASE(1980年至2009年6月)。我们还检索了正在进行的试验和研究注册库,检查了相关文章的参考文献列表,并联系了同事、试验作者和研究人员。
将EC/IC旁路手术联合最佳药物治疗与单纯最佳药物治疗进行比较以预防后续卒中、改善脑血流动力学并降低卒中后依赖程度的随机对照试验(RCT)和非随机研究。
两位综述作者独立选择纳入研究,并将结局事件数量的数据项提取到数据提取表上。只有当研究提供了至少一项主要结局的信息时,我们才分析次要结局。我们还尽可能采用意向性分析。
我们纳入了21项试验,包括两项RCT,涉及2591名患者。对于所有终点,在RCT中(任何死亡:比值比(OR)0.81,95%置信区间(CI)0.62至1.05,P = 0.11;卒中:OR 0.99,95%CI 0.79至1.23,P = 0.91;死亡和依赖:OR 0.94,95%CI 0.74至1.21,P = 0.64)或在非RCT中(任何死亡:OR 1.00,95%CI 0.62至1.62,P = 0.99;卒中:OR 0.80,95%CI 0.54至1.18,P = 0.25;死亡和依赖:OR 0.80,95%CI 0.50至1.29,P = 0.37),均未显示EC/IC旁路手术有优势。
sCAO疾病患者的EC/IC旁路手术并不优于也不劣于单纯药物治疗。然而,大多数研究纳入患者时未考虑其脑血流动力学情况。建议参与一项正在进行的RCT,该试验仅限于血流动力学受损的患者,因为这些患者可能从旁路手术中获益。