Müller Mandy D, Lyrer Philippe, Brown Martin M, Bonati Leo H
University Hospital Basel, Department of Neurology and Stroke Center, Petersgraben 4, Basel, Switzerland, 4031.
UCL Institute of Neurology, Department of Brain Repair & Rehabilitation, Box 6, The National Hospital, Queen Square, London, UK, WC1N 3BG.
Cochrane Database Syst Rev. 2020 Feb 25;2(2):CD000515. doi: 10.1002/14651858.CD000515.pub5.
Carotid artery stenting is an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis. This review updates a previous version first published in 1997 and subsequently updated in 2004, 2007, and 2012.
To assess the benefits and risks of stenting compared with endarterectomy in people with symptomatic or asymptomatic carotid stenosis.
We searched the Cochrane Stroke Group Trials Register (last searched August 2018) and the following databases: CENTRAL, MEDLINE, Embase, and Science Citation Index to August 2018. We also searched ongoing trials registers (August 2018) and reference lists, and contacted researchers in the field.
Randomised controlled trials (RCTs) comparing stenting with endarterectomy for symptomatic or asymptomatic atherosclerotic carotid stenosis. In addition, we included RCTs comparing carotid artery stenting with medical therapy alone.
One review author selected trials for inclusion, assessed trial quality and risk of bias, and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with endarterectomy as the reference group. We quantified heterogeneity using the I² statistic and used GRADE to assess the overall certainty of evidence.
We included 22 trials involving 9753 participants. In participants with symptomatic carotid stenosis, compared with endarterectomy stenting was associated with a higher risk of periprocedural death or stroke (the primary safety outcome; OR 1.70, 95% CI 1.31 to 2.19; P < 0.0001, I² = 5%; 10 trials, 5396 participants; high-certainty evidence); and periprocedural death, stroke, or myocardial infarction (OR 1.43, 95% CI 1.14 to 1.80; P = 0.002, I² = 0%; 6 trials, 4861 participants; high-certainty evidence). The OR for the primary safety outcome was 1.11 (95% CI 0.74 to 1.64) in participants under 70 years old and 2.23 (95% CI 1.61 to 3.08) in participants 70 years old or more (interaction P = 0.007). There was a non-significant increase in periprocedural death or major or disabling stroke with stenting (OR 1.36, 95% CI 0.97 to 1.91; P = 0.08, I² = 0%; 7 trials, 4983 participants; high-certainty evidence). Compared with endarterectomy, stenting was associated with lower risks of myocardial infarction (OR 0.47, 95% CI 0.24 to 0.94; P = 0.03, I² = 0%), cranial nerve palsy (OR 0.09, 95% CI 0.06 to 0.16; P < 0.00001, I² = 0%), and access site haematoma (OR 0.32, 95% CI 0.15 to 0.68; P = 0.003, I² = 27%). The combination of periprocedural death or stroke or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured endarterectomy (OR 1.51, 95% CI 1.24 to 1.85; P < 0.0001, I² = 0%; 8 trials, 5080 participants; high-certainty evidence). The rate of ipsilateral stroke after the periprocedural period did not differ between treatments (OR 1.05, 95% CI 0.75 to 1.47; P = 0.77, I² = 0%). In participants with asymptomatic carotid stenosis, there was a non-significant increase in periprocedural death or stroke with stenting compared with endarterectomy (OR 1.72, 95% CI 1.00 to 2.97; P = 0.05, I² = 0%; 7 trials, 3378 participants; moderate-certainty evidence). The risk of periprocedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR 1.27, 95% CI 0.87 to 1.84; P = 0.22, I² = 0%; 6 trials, 3315 participants; moderate-certainty evidence). Moderate or higher carotid artery restenosis (50% or greater) or occlusion during follow-up was more common after stenting (OR 2.00, 95% CI 1.12 to 3.60; P = 0.02, I² = 44%), but the difference in risk of severe restenosis was not significant (70% or greater; OR 1.26, 95% CI 0.79 to 2.00; P = 0.33, I² = 58%; low-certainty evidence).
AUTHORS' CONCLUSIONS: Stenting for symptomatic carotid stenosis is associated with a higher risk of periprocedural stroke or death than endarterectomy. This extra risk is mostly attributed to an increase in minor, non-disabling strokes occurring in people older than 70 years. Beyond the periprocedural period, carotid stenting is as effective in preventing recurrent stroke as endarterectomy. However, combining procedural safety and long-term efficacy in preventing recurrent stroke still favours endarterectomy. In people with asymptomatic carotid stenosis, there may be a small increase in the risk of periprocedural stroke or death with stenting compared with endarterectomy. However, CIs of treatment effects were wide and further data from randomised trials in people with asymptomatic stenosis are needed.
颈动脉支架置入术是治疗动脉粥样硬化性颈动脉狭窄的一种替代颈动脉内膜切除术的方法。本综述更新了先前于1997年首次发表、随后在2004年、2007年和2012年更新的版本。
评估与内膜切除术相比，支架置入术对有症状或无症状颈动脉狭窄患者的益处和风险。
我们检索了Cochrane卒中组试验注册库（最后检索时间为2018年8月）以及以下数据库：截至2018年8月的CENTRAL、MEDLINE、Embase和科学引文索引。我们还检索了正在进行的试验注册库（2018年8月）和参考文献列表，并联系了该领域的研究人员。
比较支架置入术与内膜切除术治疗有症状或无症状动脉粥样硬化性颈动脉狭窄的随机对照试验（RCT）。此外，我们纳入了比较颈动脉支架置入术与单纯药物治疗的RCT。
一位综述作者选择纳入试验、评估试验质量和偏倚风险，并提取数据。另一位综述作者独立验证试验选择，第三位综述作者独立验证数据提取。我们以比值比（OR）和95%置信区间（CI）计算治疗效果，以内膜切除术作为参照组。我们使用I²统计量量化异质性，并使用GRADE评估证据的总体确定性。
我们纳入了22项试验，涉及9753名参与者。在有症状颈动脉狭窄的参与者中，与内膜切除术相比，支架置入术与围手术期死亡或卒中的风险更高相关（主要安全结局；OR 1.70，95%CI 1.31至2.19；P<0.0001，I²=5%；10项试验，5396名参与者；高确定性证据）；以及围手术期死亡、卒中或心肌梗死（OR 1.43，95%CI 1.14至1.80；P=0.002，I²=0%；6项试验，4861名参与者；高确定性证据）。70岁以下参与者的主要安全结局的OR为1.11（95%CI 0.74至1.64），70岁及以上参与者为2.23（95%CI 1.61至3.08）（交互作用P=0.007）。支架置入术使围手术期死亡或严重或致残性卒中略有增加但无统计学意义（OR 1.36，95%CI 0.97至1.91；P=0.08，I²=0%；7项试验，4983名参与者；高确定性证据）。与内膜切除术相比，支架置入术与心肌梗死风险较低相关（OR 0.47，95%CI 0.24至0.94；P=0.03，I²=0%）、颅神经麻痹（OR 0.09，95%CI 0.06至0.16；P<0.00001，I²=0%）和穿刺部位血肿（OR 0.32，95%CI 0.15至0.68；P=0.003，I²=27%）。围手术期死亡或卒中或随访期间同侧卒中的综合情况（主要的安全性和有效性综合结局）支持内膜切除术（OR 1.51，95%CI 1.24至1.85；P<0.0001，I²=0%；8项试验，5080名参与者；高确定性证据）。围手术期后同侧卒中的发生率在两种治疗方法之间无差异（OR 1.05，95%CI 0.75至1.47；P=0.77，I²=0%）。在无症状颈动脉狭窄的参与者中，与内膜切除术相比，支架置入术使围手术期死亡或卒中略有增加但无统计学意义（OR 1.72，95%CI 1.00至2.97；P=0.05，I²=0%；7项试验，3378名参与者；中等确定性证据）。两种治疗方法在随访期间围手术期死亡或卒中或同侧卒中的风险无显著差异（OR 1.27，95%CI 0.87至1.84；P=0.22，I²=0%；6项试验，3315名参与者；中等确定性证据）。随访期间中度或更高程度的颈动脉再狭窄（50%或更高）或闭塞在支架置入术后更常见（OR 2.00，95%CI 1.12至3.60；P=0.02，I²=44%），但严重再狭窄（70%或更高）风险的差异无统计学意义（OR 1.26，95%CI 0.79至2.00；P=0.33，I²=58%；低确定性证据）。
有症状颈动脉狭窄的支架置入术与围手术期卒中或死亡的风险高于内膜切除术相关。这种额外风险主要归因于70岁以上人群中轻微、非致残性卒中的增加。在围手术期之后，颈动脉支架置入术在预防复发性卒中方面与内膜切除术一样有效。然而，将手术安全性和预防复发性卒中的长期疗效相结合仍支持内膜切除术。在无症状颈动脉狭窄的患者中，与内膜切除术相比，支架置入术可能使围手术期卒中或死亡的风险略有增加。然而，治疗效果的置信区间较宽，需要来自无症状狭窄患者随机试验的进一步数据。
