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药物洗脱支架与金属裸支架经皮介入治疗静脉桥的临床结局:所有随机临床试验的综合荟萃分析。

Clinical outcomes of percutaneous interventions in saphenous vein grafts using drug-eluting stents compared to bare-metal stents: a comprehensive meta-analysisof all randomized clinical trials.

机构信息

Memphis Veterans Affairs Medical Center, Department of Medicine, Section of Cardiology, University of Tennessee Health Sciences Center, Memphis, TN 38104, USA.

出版信息

Clin Cardiol. 2012 May;35(5):291-6. doi: 10.1002/clc.21984. Epub 2012 Apr 6.

Abstract

BACKGROUND

Clinical outcomes of percutaneous coronary intervention (PCI) in patients with saphenous vein grafts (SVGs) remain poor despite the use of drug-eluting stents (DES). There is a disparity in clinical outcomes in SVG PCI based on various registries, and randomized clinical data remain scant. We conducted a meta-analysis of all existing randomized controlled trials (RCTS) comparing bare-metal stents (BMS) and DES in SVGPCIs.

HYPOTHESIS

PCI in patients with SVG disease using DES may reduce need for repeat revascularization without an excess mortality when compared to BMS.

METHODS

An aggregate data meta-analysis of clinical outcomes in RCTs comparing PCI with DES vs BMS for SVGs reporting at least 12 months of follow-up was performed. A literature search between Janurary 1, 2003 and September 30, 2011 identified 4 RCTs (812 patients; DES = 416, BMS = 396). Summary odds ratio (OR) and 95% confidence interval (CI) were calculated using the random-effects model. The primary endpoint was all-cause mortality. Secondary outcomes included nonfatal myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). These outcomes were assessed in a cumulative fashion at 30 days, 18 months, and 36 months.

RESULTS

There were no intergroup differences in baseline clinical and sociodemographic characteristics. At a median follow-up of 25 months, patients in the DES and BMS group had similar rates of death (OR: 1.63, 95% CI: 0.45-5.92), MI (OR; 0.83, 95% CI: 0.27-2.60), and MACE (OR: 0.58, 95% CI: 0.25-1.32). Patients treated with DES had lower rates of repeat revascularization (OR: 0.40, 95% CI: 0.22-0.75).

CONCLUSIONS

In this comprehensive meta-analysis of all RCTs comparing clinical outcomes of PCI using DES vs BMS in patients with SVG disease, use of DES was associated with a reduction in rate of repeat revascularization and no difference in rates of all-cause death and MI. Clin. Cardiol. 2012 DOI: 10.1002/clc.21984 Dr. Virani is supported by a Department of Veterans Affairs Health Services Research and Development Service (HSR&D) Career Development Award (CDA-09-028), and has research support from Merck and National Football League Charities (all grants to the institution and not individual). The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

摘要

背景

尽管使用药物洗脱支架(DES),但经皮冠状动脉介入治疗(PCI)治疗静脉桥血管(SVG)的临床结果仍然不佳。根据各种登记处,SVG PCI 的临床结果存在差异,并且随机临床试验数据仍然很少。我们对所有比较 SVGPCIs 中使用裸金属支架(BMS)和 DES 的现有随机对照试验(RCT)进行了荟萃分析。

假设

与 BMS 相比,DES 用于 SVG 疾病的 PCI 可能会降低再次血运重建的需求,而不会增加死亡率。

方法

对 2003 年 1 月 1 日至 2011 年 9 月 30 日期间至少随访 12 个月的比较 DES 与 BMS 治疗 SVG 的 RCT 中的临床结果进行汇总数据分析。文献检索确定了 4 项 RCT(812 例患者;DES = 416,BMS = 396)。使用随机效应模型计算汇总优势比(OR)和 95%置信区间(CI)。主要终点是全因死亡率。次要结局包括非致死性心肌梗死(MI)、再次血运重建和主要不良心脏事件(MACE)。这些结果在 30 天、18 个月和 36 个月时以累积方式进行评估。

结果

两组基线临床和社会人口统计学特征无差异。在中位数为 25 个月的随访中,DES 和 BMS 组患者的死亡率(OR:1.63,95%CI:0.45-5.92)、MI(OR:0.83,95%CI:0.27-2.60)和 MACE(OR:0.58,95%CI:0.25-1.32)相似。DES 治疗组的再次血运重建率较低(OR:0.40,95%CI:0.22-0.75)。

结论

在这项对比较 SVG 疾病 PCI 使用 DES 与 BMS 的所有 RCT 进行的综合荟萃分析中,DES 的使用与降低再次血运重建率相关,而全因死亡率和 MI 率无差异。Clin. Cardiol. 2012 DOI:10.1002/clc.21984 Virani 博士得到了美国退伍军人事务部医疗保健服务研究与发展服务部(HSR&D)职业发展奖(CDA-09-028)的支持,并且得到了默克公司和国家橄榄球联盟慈善基金会(所有赠款给机构而非个人)的研究支持。本文观点仅代表作者观点,不一定代表美国退伍军人事务部的观点。作者没有其他资助、财务关系或利益冲突需要披露。

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A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis.
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Drug-eluting or bare metal stents for the treatment of saphenous vein graft disease: a Bayesian meta-analysis.
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Drug-eluting versus bare-metal stent for treatment of saphenous vein grafts: a meta-analysis.
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