Division of Cardiology, Jewish General Hospital, Montreal, Quebec, Canada.
Am Heart J. 2010 Feb;159(2):159-169.e4. doi: 10.1016/j.ahj.2009.11.021.
The use of drug-eluting stents (DES) in degenerative vein grafts is currently an off-label indication. Recent studies have had conflicting results regarding the effectiveness and safety of this practice. The objective of this meta-analysis was to compare DES to bare-metal stents for the treatment of vein graft stenosis.
PubMed and the Cochrane clinical trials database were systematically searched to identify all randomized controlled trials (RCTs) and observational studies examining DES for vein graft stenosis published in English between 2003 and 2009. Inclusion criteria included follow-up duration > or =6 months. Data were stratified by study design and pooled using random effects models.
Twenty studies were found to meet our inclusion criteria. Eighteen studies were observational and 2 were RCTs. In observational studies, DES were associated with a reduction in major adverse cardiac events (MACE) (odds ratio [OR] 0.50, 95% CI 0.35-0.72), death (OR 0.69, 95% CI 0.53-0.91), target vessel revascularization (TVR) (OR 0.54, 95% CI 0.37-0.79), and target lesion revascularization (TLR) (OR 0.54, 95% CI 0.37-0.78). The incidence of myocardial infarction was similar between groups. In the RCTs, pooled results were inconclusive because of small sample sizes.
Although data from observational studies suggest that the use of DES for vein graft stenosis has favorable effects on MACE, death, TVR, and TLR, these data should be interpreted with caution due to their observational nature. Corresponding RCT data are inconclusive. There remains a need for large multicenter RCTs to address the effectiveness and safety of DES for vein graft stenosis.
药物洗脱支架（DES）在退行性静脉移植物中的应用目前属于超适应证使用。最近的研究对于这种治疗方法的有效性和安全性得出了相互矛盾的结果。本荟萃分析的目的是比较 DES 与裸金属支架治疗静脉移植物狭窄的效果。
系统检索了 PubMed 和 Cochrane 临床试验数据库，以确定 2003 年至 2009 年间发表的所有关于 DES 治疗静脉移植物狭窄的英文随机对照试验（RCT）和观察性研究。纳入标准包括随访时间≥6 个月。根据研究设计对数据进行分层，并使用随机效应模型进行汇总。
共发现 20 项研究符合我们的纳入标准。其中 18 项为观察性研究，2 项为 RCT。在观察性研究中，DES 与减少主要不良心脏事件（MACE）（比值比[OR]0.50，95%置信区间[CI]0.35-0.72）、死亡（OR 0.69，95%CI 0.53-0.91）、靶血管血运重建（TVR）（OR 0.54，95%CI 0.37-0.79）和靶病变血运重建（TLR）（OR 0.54，95%CI 0.37-0.78）相关。两组心肌梗死的发生率相似。在 RCT 中，由于样本量小，汇总结果没有定论。
尽管观察性研究的数据表明，DES 治疗静脉移植物狭窄对 MACE、死亡、TVR 和 TLR 有良好的效果，但由于其观察性本质，这些数据应谨慎解释。相应的 RCT 数据没有定论。仍需要开展大型多中心 RCT 来解决 DES 治疗静脉移植物狭窄的有效性和安全性问题。
