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颈动脉血管成形术和颈动脉内膜切除术治疗颈动脉狭窄疗效比较:meta分析
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摘要
本文采用Meta分析对多篇关于颈动脉狭窄治疗方法进行分析,最终纳入10项关于颈动脉狭窄介入治疗及内膜切除术两种治疗方法的随机对照研究。通过固定效应模型研究显示:颈动脉内膜切除术的卒中,死亡或卒中的发生率低于介入治疗;严重并发症死亡或致残性卒中两者之间没有显著统计意义;但是心肌梗塞、神经损伤的发生率高于介入治疗。利用随机效应模型进行分析显示:除介入治疗的颅神经损伤发生率低于内膜切除术外,其余卒中,死亡或卒中,死亡及致残性卒中,心肌梗塞,死亡、卒中或心肌梗塞,长期预后卒中或死亡等治疗结果评估指标两者之间无显著统计学意义。同时分析了试验中栓塞保护装置的应用对介入治疗并发症的影响,显示:栓塞保护装置能够有效降低卒中或死亡的发生率,具有显著统计学意义。
Background and Purpose
     Stroke is the second or third leading cause of death and the first leading cause of adult disability in all the world. Stenosis of the carotid artery constitutes a major risk factor for ischaemic stroke, especially in patients with symptomatic stenosis (recent transient ischaemic attacks, et al). However, the severity of carotid artery stenosis highly predicts risk of ipsilateral ischemic stroke.The annual risk of ipsilateral stroke doubles from 0.5% for internal carotid artery (ICA) stenosis of b50% to 1% for ICA stenosis of 50%-99%.
     Large randomized trials have convincingly shown that carotid endarterectomy have greater benefit than medical therapies alone, can significantly reduces the longterm risk of subsequent stroke from severe carotid artery stenosis.. These large, randomized, prospective trials, including the North American Symptomatic Carotid Endarterectomy Trial (NASCET), European Carotid Surgery Trial (ECST), Asymptomatic Carotid Atherosclerotic Study (ACAS), and Asymptomatic Carotid Surgery Trial (ACST). Carotid endarterectomy has been regarded as the gold standard for revascularization of severe carotid artery stenosis, and considered the first one in clinical decision-making. But surgery also have disadvantages, such as:requiring an incision in the neck, performed under general anaesthesia and its complications such as myocardial infarction and pulmonary embolism.
     Since 1990 year, Angioplasty and carotid artery stenting have been suggested as an alternative to carotid endarterectomy for revascularization of carotid artery stenosis, especially for carotid artery restenosis and in patients with high-surgical risk. Before 2005, there were more than 20 published case-series carotid Angioplasty studies involving a total of more than 24,000 patients,about half of patients were symptomatic carotid artery stenosis(51%), and 30-day stroke or death rates were 2% to 7%. Since embolic protection devices were introduced for use during carotid Angioplasty, stroke and death rate within 30 days in both symptomatic and asymptomatic patients was reduced to 1.8%, rather than 5.5% in patients treated without embolic protection devices. Endovascular treatment is usually performed via a femoral catheter, avoiding an incision in the neck and subsequent cranial and cutaneous nerve damage, and without general anesthesia and its complications.
     However, endovascular techniques also carries a risk of stroke and local complications. As a consequence, before endovascular treatment can be considered as a genuine alternative to surgery, it must be shown to be as safe and effective as surgery. Between 1998 and 2010,11 randomized studies comparing endovascular treatment of the carotid artery with surgery, there were 10 studies out come or part of the date have published, those studies include The CAVATAS trial, The Leicester trial, The Schneider Wall Stent trial, Kentucky A, Kentucky B, The CREST trial, The EVA 3S study, The Sapphire trial, The SPACE trial, The ICSS trial, The TESCAS-C trial and CREST Trial.
     This article reviews all randomized trials comparing endovascular treatment of the carotid artery with surgery by a meta-analysis,To evaluate the safety and efficacy of endovascular techniques.
     Materials and Methods
     Search Strategy
     Bibliographic databases selection
     ①MEDLINE (http://isiknowledge.com/medline);
     ②Elsevier Science (http://www.sciencedirect.com/);
     ③PubMed (http://www.ncbi.nlm.nih.gov/pubmed/)
     ④The Excerpta Medica Database, EMBASE;
     ⑤China National Knowledge Infrastructure, CNKI.
     Search terms
     Search terms included "carotid", "stenosis", "endarterectomy", "endovascular", "angioplasty", and "stenting", in various combinations.
     Study selection
     The search was limited to articles published date to 2010.01.01;
     randomized trials of carotid endovascular treatment compared with carotid endarterectomy;
     patients of any age or sex;
     symptomaticor asymptomatic carotid arterystenosis.
     Data extraction
     The outcome events extracted from each study included, if available:any stroke (disabling or nondisabling) or death, cranial neuro damage, myocardial infarction within 30 days of procedure and any stroke or death within 1 year of procedure.
     Strokes were classified if possible as fatal, disabling (requiring help with activities of daily living for>1 month after onset) or nondisabling (symptoms lasted>7 days but patient was independent at 30 days).
     Meta analysis
     Results were reported as percentages as well as odds ratios (ORs). ORs were calculated using the Peto fixed-effect method or (and) free-sffect method. Heterogeneity between trial results was tested for using a standardχ2 test.
     Results
     There are 10 trials, including 4872patients, Symptomatic carotid stenosis 4533 patients (93% in all). Meta-analysis using both random-effect model and fixed-effect model compared outcome events of death, stroke, myocardial infarction, cranial nerve injury at 30 days,6 months, or 1 year after procedure. By fixed-effect modle there were significantly lowwer 30-day event rates after CAS than CEA for stroke [1.29(1.02,1.64), heterogeneity(P=0.001)], and death or any stroke[1.25(1.00,1.57), heterogeneity(P=0.002)].But by random-effects model, there was no significant difference of event rates between treatments for stroke (odds ratio for CAS [95% confidence interval],1.21 [0.69,2.10]), death or any stroke (1.12 [0.68,1.86]), or death,disabilting stroke(1.03 [0.66,1.61]), or death and any stroke at long-term after procedural (1.11 [0.73,1.69]). But also there were significantly lowwer 30-day event rates after CAS than CEA for myocardial infarction [fixed-effect modle 0.45 (0.21,0.98), heterogeneity (p=0.55)], Cranial nerve injury [fixed-effect modle 0.08 (0.03,0.20), heterogeneity (p=0.78)] by fixed-effect model.
     Conclusion
     In the present meta-analysis, there was no significant difference of safety and benefit between patients treated with CAS and CEA.The analyzed trial number was too small to show significant different. The ongoing trials CREST is expected to provide additional clear evidence to make sure which treatment is Golden standard..
引文
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