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药物洗脱支架或金属裸支架治疗大隐静脉移植病变:贝叶斯荟萃分析。

Drug-eluting or bare metal stents for the treatment of saphenous vein graft disease: a Bayesian meta-analysis.

机构信息

Institut Universitaire de Cardiologie et de Pneumologie de Québec (Quebec Heart and Lung Institute), Quebec City, Canada.

出版信息

Circ Cardiovasc Interv. 2010 Dec;3(6):565-76. doi: 10.1161/CIRCINTERVENTIONS.110.949735. Epub 2010 Nov 23.

DOI:10.1161/CIRCINTERVENTIONS.110.949735
PMID:21098743
Abstract

BACKGROUND

Observational studies and randomized, controlled trials have yielded uncertain results regarding the benefits of drug-eluting stents (DES) for the treatment of saphenous vein graft (SVG) disease. The objective of this meta-analysis was to assess the cumulative evidence regarding the efficacy and effectiveness of DES to treat SVG compared with bare metal stent (BMS).

METHODS AND RESULTS

We conducted a bayesian hierarchical meta-analysis of all randomized, controlled trials and observational studies that compared clinical outcomes after DES or BMS placement in SVG disease. Our search resulted in 25 studies, cumulating 5755 patients. DES implantation was not associated with an increased risk of death (odds ratio [OR], 0.85; 95% credible intervals (CrI) [CrI], 0.62 to 1.21) or myocardial infarction (OR, 0.83; 95% CrI, 0.56 to 1.32), but wide CrIs preclude definitive conclusions. Target vessel revascularization (OR, 0.55; 95% CrI, 0.39 to 0.76) and target lesion revascularization (OR, 0.58; 95% CrI, 0.37 to 0.87) were both reduced by approximately 45% with DES. When combining these outcomes, the OR for major adverse cardiac events was reduced in patients treated with DES (OR, 0.62; 95% CrI, 0.46 to 0.81). Finally, the relative risk of stent thrombosis appeared lower with DES, although again the CrIs were very wide (OR, 0.54; 95% CrI, 0.13 to 1.39).

CONCLUSIONS

In this study-level meta-analysis, the largest ever reported and the first using bayesian methods, the use of DES for the treatment of SVG disease reduces target vessel revascularization and target lesion revascularization procedures compared with BMS. Although there is no evidence to date to suggest increased rates of mortality, myocardial infarction, or stent thrombosis, further data are needed to address this safety issue.

摘要

背景

观察性研究和随机对照试验对于药物洗脱支架(DES)治疗大隐静脉桥(SVG)疾病的获益结果不确定。本荟萃分析的目的是评估关于 DES 治疗 SVG 相对于金属裸支架(BMS)的疗效和有效性的累积证据。

方法和结果

我们对所有比较 DES 或 BMS 治疗 SVG 疾病后临床结局的随机对照试验和观察性研究进行了贝叶斯层次荟萃分析。我们的搜索结果共纳入 25 项研究,累计 5755 例患者。DES 植入与死亡率增加无关(比值比[OR],0.85;95%可信区间[CrI] [CrI],0.62 至 1.21)或心肌梗死(OR,0.83;95% CrI,0.56 至 1.32),但较宽的 CrI 排除了明确的结论。靶血管血运重建(OR,0.55;95% CrI,0.39 至 0.76)和靶病变血运重建(OR,0.58;95% CrI,0.37 至 0.87)均减少约 45%。当合并这些结果时,DES 治疗患者的主要不良心脏事件的 OR 降低(OR,0.62;95% CrI,0.46 至 0.81)。最后,DES 组的支架血栓形成相对风险似乎较低,尽管 CrI 仍然非常宽(OR,0.54;95% CrI,0.13 至 1.39)。

结论

在这项基于研究水平的荟萃分析中,这是迄今为止报告的最大规模的荟萃分析,也是首次使用贝叶斯方法,DES 治疗 SVG 疾病与 BMS 相比,减少靶血管血运重建和靶病变血运重建的发生。尽管目前尚无证据表明死亡率、心肌梗死或支架血栓形成的发生率增加,但仍需要进一步的数据来解决这个安全问题。

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