Orrapin Saritphat, Rerkasem Kittipan
Division of Vascular and Endovascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), Pathumthani, Thailand.
Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD001081. doi: 10.1002/14651858.CD001081.pub3.
Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment (carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of the Cochrane Review, originally published in 1999, and most recently updated in 2011.
To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke).
We searched the Cochrane Stroke Group Trials Register (last searched in July 2016), CENTRAL (2016, Issue 7), MEDLINE (1966 to July 2016), Embase (1990 to July 2016), Web of Science Core Collection, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) portal, and handsearched relevant journals and reference lists.
We included randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data.
We included three trials involving 6343 participants. As the trials differed in the methods of measurement of carotid stenosis and in the definition of stroke, we did a pooled analysis of individual patient data on 6092 participants (35,000 patient years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials using the primary electronic data files, and redefined outcome events where necessary, to achieve comparability.On re-analysis, there were no significant differences between the trials in the risks of any of the main outcomes in either of the treatment groups, or in the effects of surgery. Surgery increased the five-year risk of ipsilateral ischaemic stroke in participants with less than 30% stenosis (N = 1746, risk ratio (RR) 1.27, 95% confidence interval (CI) 0.80 to 2.01), had no significant effect in participants with 30% to 49% stenosis (N = 1429, RR 0.93, 95%CI 0.62 to 1.38), was of benefit in participants with 50% to 69% stenosis (N = 1549, RR 0.84, 95%CI 0.60 to 1.18), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (N = 1095, RR 0.47, 95%CI 0.25 to 0.88). However, there was no evidence of benefit (N = 271, RR 1.03, 95%CI 0.57 to 1.84) in participants with near-occlusions. Ipsilateral ischaemic stroke describes insufficient blood flow to the cerebral hemisphere, secondary to same side severe stenosis of the internal carotid artery.
AUTHORS' CONCLUSIONS: Endarterectomy was of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence), and highly beneficial for those with 70% to 99% stenosis without near-occlusion (moderate-quality evidence). We found no benefit in people with carotid near-occlusion (high-quality evidence).
中风是第三大致死原因,也是长期残疾的最常见原因。颈动脉严重狭窄是中风的一个重要原因。手术治疗(颈动脉内膜切除术)可能会降低中风风险,但存在手术并发症风险。这是Cochrane系统评价的更新版,最初发表于1999年,最近一次更新是在2011年。
确定近期有症状性颈动脉狭窄(即短暂性脑缺血发作(TIA)或非致残性中风)的患者,与单纯最佳药物治疗相比,内膜切除术加最佳药物治疗的利弊平衡。
我们检索了Cochrane中风组试验注册库(最后检索时间为2016年7月)、Cochrane系统评价数据库(2016年第7期)、医学期刊数据库(1966年至2016年7月)、Embase数据库(1990年至2016年7月)、科学引文索引核心合集、临床试验.gov、世界卫生组织国际临床试验注册平台(ICTRP)门户,并手工检索了相关期刊和参考文献列表。
我们纳入了随机对照试验。
两位综述作者独立选择研究、评估偏倚风险并提取数据。
我们纳入了三项试验,涉及6343名参与者。由于试验在颈动脉狭窄的测量方法和中风的定义上存在差异,我们在使用原始电子数据文件重新评估了所有三项试验的颈动脉血管造影和结果,并在必要时重新定义结局事件以实现可比性之后,对6092名参与者(35000患者年的随访)的个体患者数据进行了汇总分析。重新分析后,两个治疗组中任何主要结局的风险在试验之间均无显著差异,手术效果也无显著差异。手术增加了狭窄程度小于30%的参与者同侧缺血性中风的五年风险(N = 1746,风险比(RR)1.27,95%置信区间(CI)0.80至2.01),对狭窄程度为30%至49%的参与者无显著影响(N = 1429,RR 0.93,95%CI 0.62至1.38),对狭窄程度为50%至69%的参与者有益(N = 1549,RR 0.84,95%CI 0.60至1.18),对狭窄程度为70%至99%且无近乎闭塞的参与者非常有益(N = 1095,RR 0.47,95%CI 0.25至0.88)。然而,对于近乎闭塞的参与者,没有获益的证据(N = 271,RR 1.03,95%CI 0.57至1.84)。同侧缺血性中风是指由于同侧颈内动脉严重狭窄导致大脑半球血流不足。
内膜切除术对狭窄程度为50%至69%的有症状性狭窄参与者有一定益处(中等质量证据),对狭窄程度为70%至99%且无近乎闭塞的参与者非常有益(中等质量证据)。我们发现对于颈动脉近乎闭塞的患者没有益处(高质量证据)。