Toyota Toshiaki, Shiomi Hiroki, Morimoto Takeshi, Kimura Takeshi
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
Am J Cardiol. 2015 Jul 15;116(2):187-94. doi: 10.1016/j.amjcard.2015.03.059. Epub 2015 Apr 16.
The superiority of everolimus-eluting stents (EES) over sirolimus-eluting stents (SES) for long-term clinical outcomes has not been yet firmly established. We conducted a systematic review and a meta-analysis of randomized controlled trials (RCTs) comparing EES directly with SES using the longest available follow-up data. We searched PubMed, the Cochrane database, and ClinicalTrials.gov for RCTs comparing outcomes between EES and SES and identified 13,434 randomly assigned patients from 14 RCTs. EES was associated with significantly lower risks than SES for definite stent thrombosis (ST), definite/probable ST, target-lesion revascularization (TLR), and major adverse cardiac events (MACE). The risks for all-cause death and myocardial infarction were similar between EES and SES. By the stratified analysis according to the timing after stent implantation, the favorable trend of EES relative to SES for ST, TLR, and MACE was consistently observed both within and beyond 1 year. The lower risk of EES relative to SES for MACE beyond 1 year was statistically significant (pooled odds ratio 0.77, 95% confidence interval 0.61 to 0.96, p = 0.02). In conclusion, the current meta-analysis of 14 RCTs directly comparing EES with SES suggested that EES provided improvement in both safety and efficacy; EES compared with SES was associated with significantly lower risk for definite ST, definite/probable ST, TLR, and MACE. The direction and magnitude of the effect beyond 1 year were comparable with those observed within 1 year.
依维莫司洗脱支架（EES）在长期临床疗效方面相对于西罗莫司洗脱支架（SES）的优势尚未得到确凿证实。我们利用可获得的最长随访数据，对比较EES与SES的随机对照试验（RCT）进行了系统评价和荟萃分析。我们在PubMed、Cochrane数据库和ClinicalTrials.gov中检索了比较EES和SES疗效的RCT，从14项RCT中确定了13434例随机分组患者。与SES相比，EES在明确支架血栓形成（ST）、明确/可能ST、靶病变血运重建（TLR）和主要不良心脏事件（MACE）方面的风险显著更低。EES和SES在全因死亡和心肌梗死风险方面相似。根据支架植入后的时间进行分层分析，在1年以内和超过1年时均一致观察到EES相对于SES在ST、TLR和MACE方面的有利趋势。EES相对于SES在1年以上MACE方面的较低风险具有统计学意义（合并比值比0.77，95%置信区间0.61至0.96，p = 0.02）。总之，目前对14项直接比较EES与SES的RCT进行的荟萃分析表明，EES在安全性和有效性方面均有改善；与SES相比，EES在明确ST、明确/可能ST、TLR和MACE方面的风险显著更低。1年以上的效应方向和幅度与1年以内观察到的相当。
