Bonati Leo H, Lyrer Philippe, Ederle Jörg, Featherstone Roland, Brown Martin M
Department ofNeurology,UniversityHospital Basel, Basel, Switzerland.
Cochrane Database Syst Rev. 2012 Sep 12(9):CD000515. doi: 10.1002/14651858.CD000515.pub4.
Endovascular treatment by transluminal balloon angioplasty or stent insertion may be a useful 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 and 2007.
To assess the benefits and risks of endovascular treatment compared with carotid endarterectomy or medical therapy in patients with symptomatic or asymptomatic carotid stenosis.
We searched the Cochrane Stroke Group Trials Register (last searched January 2012) and the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4), MEDLINE (1950 to January 2011), EMBASE (1980 to January 2011) and Science Citation Index (1945 to January 2011). We also searched ongoing trials registers (January 2011) and reference lists and contacted researchers in the field.
Randomised trials comparing endovascular treatment (including balloon angioplasty or stenting) with endarterectomy or medical therapy for symptomatic or asymptomatic atherosclerotic carotid stenosis.
One review author selected trials for inclusion, assessed trial quality 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 endovascular treatment as the reference group. We quantified heterogeneity using the I(2) statistic.
We included 16 trials involving 7572 patients. In patients with symptomatic carotid stenosis at standard surgical risk, endovascular treatment was associated with a higher risk of the following outcome measures occurring between randomisation and 30 days after treatment than endarterectomy: death or any stroke (the primary safety outcome) (OR 1.72, 95% CI 1.29 to 2.31, P = 0.0003; I(2) = 27%), death or any stroke or myocardial infarction (OR 1.44, 95% CI 1.15 to 1.80, P = 0.002; I(2) = 7%), and any stroke (OR 1.81, 95% CI 1.40 to 2.34, P < 0.00001;I(2) = 12%). The OR for the primary safety outcome was 1.16 (95% CI 0.80 to 1.67) in patients < 70 years old and 2.20 (95% CI 1.47 to 3.29) in patients ≥ 70 years old (interaction P = 0.02).The rate of death or major or disabling stroke did not differ significantly between treatments (OR 1.28, 95% CI 0.93 to 1.77, P = 0.13; I(2) = 0%). Endovascular treatment was associated with lower risks of myocardial infarction (OR 0.44, 95% CI 0.23 to 0.87, P = 0.02; I(2) = 0%), cranial nerve palsy (OR 0.08, 95% CI 0.05 to 0.14, P < 0.00001; I(2) = 0%) and access site haematomas (OR 0.37, 95% CI 0.18 to 0.77, P = 0.008; I(2) = 27%).The combination of death or any stroke up to 30 days after treatment or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured endarterectomy (OR 1.39, 95% CI 1.10 to 1.75, P = 0.005; I(2) = 0%), but the rate of ipsilateral stroke after the peri-procedural period did not differ between treatments (OR 0.93, 95% CI 0.60 to 1.45, P = 0.76; I(2) = 0%).Restenosis during follow-up was more common in patients receiving endovascular treatment than in patients assigned surgery (OR 2.41, 95% CI 1.28 to 4.53, P = 0.007; I(2) = 55%). In patients with asymptomatic carotid stenosis, treatment effects on the primary safety (OR 1.71, 95% CI 0.78 to 3.76, P = 0.18; I(2) = 0%) and combined safety and efficacy outcomes (OR 1.75, 95% CI 0.92 to 3.33, P = 0.09; I(2) = 0%) were similar to symptomatic patients, but differences between treatments were not statistically significant. Among patients not suitable for surgery, the rate of death or any stroke between randomisation and end of follow-up did not differ significantly between endovascular treatment and medical care (OR 0.22, 95% CI 0.01 to 7.92, P = 0.41; I(2)= 79%).
AUTHORS' CONCLUSIONS: Endovascular treatment is associated with an increased risk of peri-procedural stroke or death compared with endarterectomy. However, this excess risk appears to be limited to older patients. The longer term efficacy of endovascular treatment and the risk of restenosis are unclear and require further follow-up of existing trials. Further trials are needed to determine the optimal treatment for asymptomatic carotid stenosis.
经皮腔内球囊血管成形术或支架置入术等血管内治疗可能是治疗动脉粥样硬化性颈动脉狭窄的一种有用替代方法，可替代颈动脉内膜切除术。本综述更新了1997年首次发表、随后在2004年和2007年更新的上一版本。
评估血管内治疗与颈动脉内膜切除术或药物治疗相比，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2012年1月）以及以下数据库：Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2010年第4期）、MEDLINE（1950年至2011年1月）、EMBASE（1980年至2011年1月）和科学引文索引（1945年至2011年1月）。我们还检索了正在进行的试验注册库（2011年1月）和参考文献列表，并联系了该领域的研究人员。
比较血管内治疗（包括球囊血管成形术或支架置入术）与内膜切除术或药物治疗对有症状或无症状动脉粥样硬化性颈动脉狭窄的随机试验。
一位综述作者选择纳入试验、评估试验质量并提取数据。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。我们将治疗效果计算为比值比（OR）和95%置信区间（CI），以血管内治疗作为参照组。我们使用I²统计量对异质性进行量化。
我们纳入了16项试验，涉及7572例患者。在具有标准手术风险的有症状颈动脉狭窄患者中，与内膜切除术相比，血管内治疗在随机分组至治疗后30天期间发生以下结局指标的风险更高：死亡或任何卒中（主要安全性结局）（OR 1.72，95%CI 1.29至2.31，P = 0.0003；I² = 27%）、死亡或任何卒中或心肌梗死（OR 1.44，95%CI 1.15至1.80，P = 0.002；I² = 亦7%）以及任何卒中（OR 1.81，95%CI 1.40至2.34，P < 0.00001；I² = 12%）。主要安全性结局的OR在<70岁患者中为1.16（95%CI 0.80至1.67），在≥70岁患者中为2.20（95%CI 1.47至3.29）（交互作用P = 0.02）。治疗之间死亡或严重或致残性卒中的发生率无显著差异（OR 1.28，95%CI 0.93至1.77，P = 0.13；I² = 0%）。血管内治疗与较低的心肌梗死风险（OR 0.44，95%CI 0.23至0.87，P = 0.02；I² = 0%）、颅神经麻痹风险（OR 0.08，95%CI 0.05至0.14，P < 0.00001；I² = 0%）和穿刺部位血肿风险（OR 0.37，95%CI 0.18至0.77，P = 0.008；I² = 27%）相关。治疗后30天内死亡或任何卒中或随访期间同侧卒中的联合情况（主要联合安全性和有效性结局）支持内膜切除术（OR 1.39，95%CI 1.10至1.75，P = 0.005；I² = 0%），但围手术期后同侧卒中的发生率在治疗之间无差异（OR 0.93，95%CI 0.60至1.45，P = 0.76；I² = 0%）。随访期间再狭窄在接受血管内治疗的患者中比接受手术的患者更常见（OR 亦2.41，95%CI 1.28至4.53，P = 0.007；I² = 55%）。在无症状颈动脉狭窄患者中，对主要安全性（OR 1.71，95%CI 0.78至3.76，P = 0.18；I² = 0%）和联合安全性及有效性结局（OR 1.75，95%CI 0.92至3.33，P =亦0.09；I² = 0%）的治疗效果与有症状患者相似，但治疗之间的差异无统计学意义。在不适合手术的患者中，血管内治疗与药物治疗在随机分组至随访结束之间死亡或任何卒中的发生率无显著差异（OR 0.22，95%CI 0.01至7.92，P = 0.41；I² = 79%）。
与内膜切除术相比，血管内治疗与围手术期卒中或死亡风险增加相关。然而，这种额外风险似乎仅限于老年患者。血管内治疗的长期疗效和再狭窄风险尚不清楚，需要对现有试验进行进一步随访。需要进一步的试验来确定无症状颈动脉狭窄的最佳治疗方法。
