Piscione Federico, Piccolo Raffaele, Cassese Salvatore, Galasso Gennaro, Chiariello Massimo
Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Naples, Italy.
Catheter Cardiovasc Interv. 2009 Aug 1;74(2):323-32. doi: 10.1002/ccd.22017.
To evaluate outcome of patients undergoing sirolimus-eluting stent (SES) as compared to bare-metal stent (BMS) implantation during primary angioplasty for ST-segment elevation myocardial infarction (STEMI).
The role of SES in primary percutaneous coronary intervention setting is still debated.
We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow-up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target-vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI).
Six trials were included in the meta-analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12-month follow-up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24-0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52-1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52-1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45-1.11], P = 0.13) between the two groups.
SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow-up. Further studies with larger population and longer follow-up time are needed to confirm our findings.
评估在ST段抬高型心肌梗死(STEMI)的直接血管成形术中,接受西罗莫司洗脱支架(SES)植入的患者与接受裸金属支架(BMS)植入的患者的预后情况。
SES在直接经皮冠状动脉介入治疗中的作用仍存在争议。
我们检索了Medline、EMBASE、CENTRAL、科学会议摘要以及相关网站,以查找从各数据库建立至2008年10月的任何语言的研究。仅纳入平均随访期>6个月且样本量>100例患者的随机临床试验。疗效的主要终点是靶血管血运重建(TVR),安全性的主要终点是支架血栓形成。次要终点是心源性死亡和再发心肌梗死(MI)。
荟萃分析纳入了6项试验,共2381例患者(1192例随机接受SES治疗,1189例随机接受BMS治疗)。随访至12个月时,接受SES治疗的患者的TVR显著低于接受BMS治疗的患者(分别为4.53%和12.53%;比值比[OR]0.33;95%置信区间[CI]0.24 - 0.46;P < 0.00001)。两组之间支架血栓形成的发生率(3.02%对3.70%,OR = 0.81[95%CI,0.52 - 1.27],P = 0.81)、心源性死亡(2.77%对3.28%,OR = 0.84[95%CI,0.52 - 1.35],P = 0.47)和再发MI(2.94%对4.04%,OR = 0.71[95%CI,0.45 - 1.11],P = 0.13)无显著差异。
在随访长达1年的STEMI患者中,与BMS相比,SES显著降低TVR率。需要进一步开展更大规模人群和更长随访时间的研究来证实我们的发现。