西罗莫司洗脱支架与紫杉醇洗脱支架在支架内血栓形成方面是否存在显著差异？一项随机对照试验的系统评价和荟萃分析。

Is There Any Significant Difference in Stent Thrombosis Between Sirolimus and Paclitaxel Eluting Stents?: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Bundhun Pravesh Kumar, Wu Zi Jia, Chen Meng-Hua

机构信息

From the Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, P. R. China.

出版信息

Medicine (Baltimore). 2016 Feb;95(5):e2651. doi: 10.1097/MD.0000000000002651.

Several meta-analyses have shown no significant difference in stent thrombosis (ST) between sirolimus eluting stents (SES) and paclitaxel eluting stents (PES). However, other meta-analyses have found SES to be superior to PES. Therefore, to solve this issue, we aim to compare the clinical outcomes between SES and PES during a follow-up period of about 1 or more years.We have searched Medline and EMBASE for randomized controlled trials (RCTs) comparing SES with PES. These RCTs have been carefully analyzed and then different types of ST including ST defined by the Academic Research Consortium (ARC), acute ST, late and very late ST have all been considered as the clinical endpoints in this study. A follow-up period of about 1 year, between 1 and 2 years as well as a longer follow-up period between 1 and 5 years have been considered. Data were retrieved and combined by means of a fixed-effect model because of a lower heterogeneity observed among the results. Odd ratios (OR) and 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software.Twenty-nine studies from 19 RCTs comprising of 16,724 patients (8115 patients in the SES group and 8609 patients in the PES group) satisfied the inclusion criteria and were included in this meta-analysis. No significant differences in ST have been observed between SES and PES. Results were as follow: definite ST with OR: 0.87; 95% CI: 0.64-1.18, P = 0.36; probable ST with OR:0.72; 95% CI: 0.42-1.21, P = 0.21; definite, probable and/or possible ST with OR: 0.94; 95% CI: 0.75-1.17, P = 0.57; acute ST with OR: 0.99; 95% CI: 0.38-2.56, P = 0.98; subacute ST with OR: 0.72; 95% CI: 0.41-1.25, P = 0.25; early ST with OR: 0.81; 95% CI: 0.53-1.25, P = 0.34; late ST with OR: 0.72; 95% CI: 0.39-1.34, P = 0.30; very late ST with OR: 1.02; 95% CI: 0.72-1.44, P = 0.92; and any ST with OR: 0.86; 95% CI: 0.69-1.07, P = 0.18. Long-term ST between 1 and 5 years with OR: 0.93; 95% CI: 0.71-1.22, P = 0.60 was also not significantly different.No significant difference in ST has been observed between patients treated with either SES or PES. Hence SES and PES can both be considered almost equally effective.

多项荟萃分析表明，西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）在支架内血栓形成（ST）方面无显著差异。然而，其他荟萃分析发现SES优于PES。因此，为解决这一问题，我们旨在比较SES和PES在约1年或更长时间的随访期内的临床结局。我们检索了Medline和EMBASE，以查找比较SES和PES的随机对照试验（RCT）。对这些RCT进行了仔细分析，然后将不同类型的ST，包括学术研究联盟（ARC）定义的ST、急性ST、晚期和极晚期ST，均视为本研究的临床终点。考虑了约1年、1至2年以及1至5年的更长随访期。由于结果之间观察到的异质性较低，数据通过固定效应模型进行检索和合并。计算比值比（OR）和95%置信区间（CI），并使用RevMan 5.3软件进行汇总分析。来自19项RCT的29项研究，共16724例患者（SES组8115例患者，PES组8609例患者）符合纳入标准并纳入本荟萃分析。SES和PES之间未观察到ST的显著差异。结果如下：明确ST的OR为0.87；95%CI为0.64 - 1.18，P = 0.36；可能ST的OR为0.72；95%CI为0.42 - 1.21，P = 0.21；明确、可能和/或可能ST的OR为0.94；95%CI为0.75 - 1.17，P = 0.57；急性ST的OR为0.99；95%CI为0.38 - 2.56，P = 0.98；亚急性ST的OR为0.72；95%CI为0.41 - 1.25，P = 0.25；早期ST的OR为0.81；95%CI为0.53 - 1.25，P = 0.34；晚期ST的OR为0.72；95%CI为0.39 - 1.34，P = 0.30；极晚期ST的OR为1.02；95%CI为0.72 - 1.44，P = 0.92；任何ST的OR为0.86；95%CI为0.69 - 1.07，P = 0.18。1至5年的长期ST的OR为0.93；95%CI为0.71 - 1.22，P = 0.60，也无显著差异。接受SES或PES治疗的患者之间未观察到ST的显著差异。因此，SES和PES均可被视为几乎同样有效。