Pan Xiao-hong, Zhong Wen-zhao, Xiang Mei-xiang, Xu Geng, Shan Jiang, Wang Jian-an
Department of Cardiology, 2nd Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China.
Chin Med J (Engl). 2009 Jan 5;122(1):88-92.
The benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue percutaneous coronary intervention (PCI). A meta-analysis of randomised trials comparing SES and bare-metal stent (BMS) was performed.
A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events (MACEs). The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.
Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group (9.7% vs 20.3%, OR 2.45, 95% CI 1.88-3.19, P < 0.00001). No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group (5.1% vs 14.8%, OR 3.30, 95% CI 2.37-4.60, P < 0.00001). No significant difference was found between the pooled rates of stent thrombosis (1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95% CI 0.79-3.26, P = 0.19).
SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.
在接受直接或补救性经皮冠状动脉介入治疗(PCI)的ST段抬高型心肌梗死(STEMI)患者中,不同试验尚未对西罗莫司洗脱支架(SES)的益处和安全性进行系统量化。我们对比较SES和裸金属支架(BMS)的随机试验进行了荟萃分析。
进行系统的文献检索以识别所有随机临床试验。主要结局是主要不良心脏事件(MACE)发生率。次要结局包括死亡、再发心肌梗死、再次血运重建和支架血栓形成。
共有1973例STEMI患者纳入了7项比较SES与BMS的合格随机试验。SES组主要不良心脏事件的合并发生率显著低于BMS组(9.7%对20.3%,OR 2.45,95%CI 1.88 - 3.19,P < 0.00001)。SES组和BMS组在全因死亡率以及合并再发心肌梗死发生率方面均未发现显著差异。SES组的合并再次血运重建率显著低于BMS组(5.1%对14.8%,OR 3.30,95%CI 2.37 - 4.60,P < 0.00001)。支架血栓形成的合并发生率在两组间未发现显著差异(SES组为1.2%,BMS组为2.0%,OR 1.61,95%CI 0.79 - 3.26,P = 0.19)。
与BMS相比,SES与主要不良心脏事件风险降低相关,这主要是由于STEMI患者再次血运重建的减少幅度更大。需要进行更大规模、随访时间更长的试验,以更好地明确SES在STEMI中的作用。