Kakkos Stavros K, Kakisis Ioannis, Tsolakis Ioannis A, Geroulakos George
Department of Vascular Surgery, University of Patras Medical School, Patras, Greece; Department of Surgery and Cancer, Imperial College London, London, United Kingdom.
National and Kapodistrian University of Athens, Athens, Greece.
J Vasc Surg. 2017 Aug;66(2):607-617. doi: 10.1016/j.jvs.2017.04.053.
It is currently unclear if carotid artery stenting (CAS) is as safe as carotid endarterectomy (CEA) for patients with significant asymptomatic stenosis. The aim of our study was to perform a systematic review and meta-analysis of trials comparing CAS with CEA.
On March 17, 2017, a search for randomized controlled trials was performed in MEDLINE and Scopus databases with no time limits. We performed meta-analyses with Peto odds ratios (ORs) and 95% confidence intervals (CIs). Quality of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation method. The primary safety and efficacy outcome measures were stroke or death rate at 30 days and ipsilateral stroke at 1 year (including ipsilateral stroke and death rate at 30 days), respectively. Perioperative stroke, ipsilateral stroke, myocardial infarction (MI), and cranial nerve injury (CNI) were all secondary outcome measures.
The systematic review of the literature identified nine randomized controlled trials reporting on 3709 patients allocated into CEA (n = 1479) or CAS (n = 2230). Stroke or death rate at 30 days was significantly higher for CAS (64/2176 [2.94%]) compared with CEA (27/1431 [1.89%]; OR, 1.57; 95% CI, 1.01-2.44; P = .044), with low level of heterogeneity beyond chance (I = 0%). Also, stroke rate at 30 days was significantly higher for CAS (63/2176 [2.90%]) than for CEA (26/1431 [1.82%]; OR, 1.63; 95% CI, 1.04-2.54; P = .032; I = 0%). MI at 30 days was nonsignificantly lower for CAS (12/1815 [0.66%]) compared with CEA (16/1070 [1.50%]; OR, 0.53; 95% CI, 0.24-1.14; P = .105; I = 0%); however, CNI at 30 days was significantly lower for CAS (2/1794 [0.11%]) than for CEA (33/1061 [3.21%]; OR, 0.13; 95% CI, 0.07-0.26; P < .00001; I = 0%). Regarding the long-term outcome of stroke or death rate at 30 days plus ipsilateral stroke during follow-up, this was significantly higher for CAS (79/2173 [3.64%]) than for CEA (35/1430 [2.45%]; OR, 1.51; 95% CI, 1.02-2.24; P = .04; I = 0%). Quality of evidence for all stroke outcomes was graded moderate.
Among patients with asymptomatic stenosis undergoing carotid intervention, there is moderate-quality evidence to suggest that CEA had significantly lower 30-day stroke and also stroke or death rates compared with CAS at the cost of higher CNI and nonsignificantly higher MI rates. The long-term efficacy of CEA in ipsilateral stroke prevention, taking into account perioperative stroke and death, was preserved during follow-up. There is an urgent need for high-quality research before a firm recommendation is made that CAS is inferior or not to CEA.
目前尚不清楚对于有显著无症状性狭窄的患者,颈动脉支架置入术(CAS)是否与颈动脉内膜切除术(CEA)一样安全。我们研究的目的是对比较CAS与CEA的试验进行系统评价和荟萃分析。
2017年3月17日,在MEDLINE和Scopus数据库中进行了无时间限制的随机对照试验检索。我们采用Peto比值比(OR)和95%置信区间(CI)进行荟萃分析。证据质量采用推荐分级评估、制定和评价方法进行评估。主要的安全性和有效性结局指标分别为30天时的卒中或死亡率以及1年时的同侧卒中(包括30天时的同侧卒中和死亡率)。围手术期卒中、同侧卒中、心肌梗死(MI)和颅神经损伤(CNI)均为次要结局指标。
对文献的系统评价确定了9项随机对照试验,报告了3709例被分配接受CEA(n = 1479)或CAS(n = 2230)的患者。与CEA(27/1431 [1.89%])相比,CAS在30天时的卒中或死亡率显著更高(64/2176 [2.94%]);OR为1.57;95% CI为1.01 - 2.44;P = 0.044,异质性水平较低,超出偶然范围(I² = 0%)。此外,CAS在30天时的卒中率(63/2176 [2.90%])显著高于CEA(26/1431 [1.82%]);OR为1.63;95% CI为1.04 - 2.54;P = 0.032;I² = 0%。CAS在30天时的MI发生率(12/1815 [0.66%])与CEA(16/1070 [1.50%])相比无显著降低;OR为0.53;95% CI为