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颈动脉狭窄血管内治疗与手术治疗安全性的比较:一项荟萃分析。

Safety of endovascular treatment of carotid artery stenosis compared with surgical treatment: a meta-analysis.

作者信息

Ringleb Peter A, Chatellier Gilles, Hacke Werner, Favre Jean-Pierre, Bartoli Jean-Michel, Eckstein Hans H, Mas Jean-Louis

机构信息

Department of Neurology, University Clinic of the Ruprecht-Karls-University, Heidelberg, Germany.

出版信息

J Vasc Surg. 2008 Feb;47(2):350-5. doi: 10.1016/j.jvs.2007.10.035.

Abstract

BACKGROUND AND PURPOSE

Since publication of previous meta-analyses comparing endovascular and surgical treatment of patients with carotid artery stenosis, two further large-scale trials have been conducted, almost doubling the number of patients available for analysis. Therefore, it is justified to update these meta-analyses.

METHODS

Relevant trials were identified by a search of the literature using an electronic database. Trials with a nonrandomized patient allocation were not included. We focused on events within 30 days after intervention and made two sets of analysis: one with all trials and one with large trials exclusively including symptomatic patients.

RESULTS

Only Endartérectomie Versus Angioplastie chez les patients ayant une Sténose carotide Symptomatique Serrée (EVA3S) and Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) were identified to be included in the updated meta-analysis. In total, 2985 patients were included in eight trials of which 89% were symptomatic. In contrast to previous analyses, this meta-analysis found a significant difference between the odds ratios of any stroke or death within 30 days after treatment with a disadvantage of endovascular treatment when analysing all trials (odds ratio [OR], 1.38; 95% confidence interval [CI] 1.04-1.83; P = .024). Significant heterogeneity was found for this analysis (P = .03). The increase of the odds of suffering from disabling stroke or death in the endovascular compared with the surgical group was not significant in the analysis of all trials (OR, 1.37; 95% CI, 0.92-2.04; P = .12); no heterogeneity was found for this analysis (P = .27). In the analysis of the large trials with symptomatic patients, the OR for the endpoint any stroke or death was 1.29 (95% CI 0.94-1.76; P = .11); with a hint for heterogeneity (P = .10). For the endpoint disabling stroke or death, the OR was 1.33 (95% CI 0.89-1.93; P =.17) without any heterogeneity (P = .58).

CONCLUSION

The expressiveness of this meta-analysis is limited by the heterogeneity of some tests. The main result is that surgical treatment still remains the gold standard for treatment of patients with symptomatic carotid artery stenosis, who do not have an increased surgical risk. Carotid artery stenting is neither safer than nor as safe as carotid endarterectomy in large clinical trials when short-term stroke and death rates are taken into account. Further recruitment into ongoing randomized trials is strongly recommended.

摘要

背景与目的

自从之前比较颈动脉狭窄患者血管内治疗与外科手术治疗的荟萃分析发表以来,又进行了另外两项大规模试验,使可供分析的患者数量几乎增加了一倍。因此,更新这些荟萃分析是合理的。

方法

通过使用电子数据库检索文献来识别相关试验。不包括患者分配为非随机的试验。我们关注干预后30天内的事件,并进行了两组分析:一组包括所有试验,另一组仅包括大型试验,且这些大型试验专门纳入有症状的患者。

结果

仅识别出“症状性严重颈动脉狭窄患者的内膜切除术与血管成形术对比研究(EVA3S)”和“颈动脉支架置入术与内膜切除术对比研究(SPACE)”可纳入更新的荟萃分析。总共有2985例患者纳入八项试验,其中89%有症状。与之前的分析不同,该荟萃分析发现,在分析所有试验时,治疗后30天内任何卒中或死亡的比值比之间存在显著差异,血管内治疗处于劣势(比值比[OR],1.38;95%置信区间[CI] 1.04 - 1.83;P = 0.024)。该分析发现存在显著异质性(P = 0.03)。在所有试验的分析中,与手术组相比,血管内治疗导致致残性卒中和死亡的几率增加并不显著(OR,1.37;95% CI,0.92 - 2.04;P = 0.12);该分析未发现异质性(P = 0.27)。在对有症状患者的大型试验分析中,终点事件任何卒中或死亡的OR为1.29(95% CI 0.94 - 1.76;P = 0.11);有提示存在异质性(P = 0.10)。对于终点事件致残性卒中和死亡,OR为1.33(95% CI 0.89 - 1.93;P = 0.17),无任何异质性(P = 0.58)。

结论

该荟萃分析的有效性受到一些试验异质性的限制。主要结果是,对于手术风险未增加的有症状颈动脉狭窄患者,外科手术治疗仍然是治疗的金标准。在考虑短期卒中和死亡率时,在大型临床试验中,颈动脉支架置入术并不比颈动脉内膜切除术更安全或与颈动脉内膜切除术一样安全。强烈建议进一步招募患者参加正在进行的随机试验。

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