Bond R, Rerkasem K, Shearman C P, Rothwell P M
Stroke Prevention Research Unit, University Department of Clinical Neurology, Radcliffe Infirmary, Oxford, UK.
Cerebrovasc Dis. 2004;18(1):37-46. doi: 10.1159/000078606. Epub 2004 May 19.
Large randomised trials performed in the 1980s and early 1990s showed that carotid endarterectomy (CEA) is beneficial for patients with recently symptomatic severe stenosis. Some surgeons have argued that the operative risk of stroke and death has fallen over the last decade due to refinements in operative technique, and that the indications for surgery should therefore now be broadened. Yet, studies of routinely collected data report higher operative mortality than in the trials, and surgical case series without independent post-operative assessment by a neurologist may not provide reliable data on stroke risk.
We performed a systematic review of all studies published between 1994 and 2001 inclusive that which reported the risks of stroke and death for symptomatic carotid stenosis, and compared the reported risks and patient characteristics with those in the ECST and NASCET and with our previous review of studies published prior to 1995. Pooled estimates of the operative risk of stroke and death were obtained by Mantel-Haenszel meta-analysis.
Of 383 studies published between 1994 and 2001, only 45 reported operative risks for patients with symptomatic stenosis separately. The pooled operative risk of stroke and death reported in studies published by surgeons only (4.2%, 95% CI = 2.9-5.5, 34 studies) was significantly lower (p < 0.0001) than that in the ECST and NASCET combined (7.0%, 95% CI = 6.2-8.0), whereas the pooled risk reported in studies that involved neurologists was similar (6.5%, 95% CI = 4.3-8.7, 11 studies, p = 0.6). In contrast, operative mortality in ECST and NASCET was significantly lower than in other studies published between 1994 and 2001. By comparison with our previous review, when stratified according to involvement of neurologists, we found no evidence of a reduction in published risks of death or stroke and death due to CEA between 1985 and 2001.
There is no evidence of a systematic reduction over the last decade in the published risks of stroke and death due to CEA for symptomatic stenosis. Operative risks in studies with comparable outcome assessment are similar to ECST and NASCET. The surgical data from the large trials are still likely therefore to be applicable to routine clinical practice.
20世纪80年代和90年代初进行的大型随机试验表明,颈动脉内膜切除术(CEA)对近期有症状的严重狭窄患者有益。一些外科医生认为,由于手术技术的改进,过去十年中风和死亡的手术风险有所下降,因此现在手术适应症应该扩大。然而,对常规收集数据的研究报告的手术死亡率高于试验中的死亡率,并且没有神经科医生独立进行术后评估的外科病例系列可能无法提供关于中风风险的可靠数据。
我们对1994年至2001年(含)间发表的所有研究进行了系统评价,这些研究报告了有症状颈动脉狭窄的中风和死亡风险,并将报告的风险和患者特征与欧洲颈动脉外科试验(ECST)和北美症状性颈动脉内膜切除术试验(NASCET)中的风险和特征以及我们之前对1995年之前发表的研究的评价进行了比较。通过Mantel-Haenszel荟萃分析获得中风和死亡手术风险的合并估计值。
在1994年至2001年间发表的383项研究中,只有45项分别报告了有症状狭窄患者的手术风险。仅由外科医生发表的研究中报告的中风和死亡合并手术风险(4.2%,95%可信区间=2.9-5.5,34项研究)显著低于ECST和NASCET合并后的风险(7.0%,95%可信区间=6.2-8.0)(p<0.0001),而涉及神经科医生的研究中报告的合并风险相似(6.5%,95%可信区间=4.3-8.7,11项研究,p=0.6)。相比之下,ECST和NASCET中的手术死亡率显著低于1994年至2001年间发表的其他研究。与我们之前的评价相比,根据神经科医生的参与情况进行分层时,我们没有发现1985年至2001年间CEA导致的已发表的死亡或中风及死亡风险降低的证据。
没有证据表明在过去十年中,已发表的有症状狭窄的CEA导致的中风和死亡风险有系统性降低。具有可比结局评估的研究中的手术风险与ECST和NASCET相似。因此,大型试验的外科数据可能仍适用于常规临床实践。