建议在常规颈动脉内膜切除术中进行补片血管成形术,与初次闭合相比,可降低再狭窄和同侧卒中复发的风险。需要对随机临床试验进行系统评价,以比较两种技术的结果(益处和危害)。
搜索(中央,PubMed/MEDLINE,EMBASE,和其他数据库)最后更新于2021年1月3日。我们纳入了随机临床试验,比较有症状和明显(>50%)颈动脉狭窄患者的颈动脉内膜切除术和补片血管成形术与动脉壁初次闭合。主要结局定义为全因死亡率和严重不良事件。
我们纳入了12项随机临床试验,包括2187名受试者,他们接受了2335例颈动脉狭窄手术,比较了颈动脉内膜切除术加贴片闭合(1280例手术)与颈动脉内膜切除术加初次闭合(1055例手术)。比较颈动脉内膜切除术加补片血管成形术与颈动脉内膜切除术加初次封堵术的Meta分析可能会降低全因死亡率患者的数量(RR0.53;95%CI0.26~1.08;p=0.08,补片最佳病例),严重不良事件(RR0.73;95%CI0.56至0.96;p=0.02,贴片的最佳情况),和再狭窄数量(RR0.41;95%CI0.23至0.71;p<0.01)。试验顺序分析表明,对于这些患者重要的结果,所需的信息大小远未达到。根据建议评估的分级,所有患者相关结局的证据确定性较低,发展,和评价。
这项系统评价没有确凿的证据表明,颈动脉内膜切除术联合补片血管成形术与动脉壁初次闭合术在全因死亡率方面存在差异。<30天死亡率,中风<30天,或任何其他严重不良事件。这些结论是基于15到35年前的数据,根据等级在非常低的确定性试验中获得,应该谨慎解释。因此,我们建议在有症状的颈内动脉狭窄≥50%的患者中,在颈动脉内膜切除术中进行新的随机临床试验.此类试验应根据《标准方案项目:介入试验建议》声明进行设计(Chan等人。,AnnInternMed1:200-7,2013),并根据《合并报告标准》报告试验声明(Schulz等人。,7,2010)。在获得确凿的证据之前,不应放弃指南规定的护理标准.
PROSPEROCRD42014013416。审查协议出版物2019DOI:https://doi.org/10.1136/bmjopen-2018-026419。
Patch angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic
review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques.
Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with
patch angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events.
We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with patch angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation.
This systematic
review showed no conclusive evidence of a difference between carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials patch angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200-7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned.
PROSPERO CRD42014013416 .
Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .