摘要
背景:与裸金属支架相比,西罗莫司洗脱支架降低了再狭窄和再介入的发生率。关于应用这两种支架行直接经皮冠状动脉介入(PCI)治疗ST段抬高型急性心肌梗死的安全性和有效性的资料有限。方法:进行了一项单盲、多中心、前瞻性、随机化试验,以比较西罗莫司洗脱支架与裸金属支架用于对ST段抬高型急性心肌梗死患者行直接PCI的效果。
BACKGROUND: Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention(PCI) for acute myocardial infarction with ST-segment elevation. METHODS: We performed a single-blind, multicenter, prospectively randomized trial to compare sirolimus-eluting stents with uncoated stents in primary PCI for acute myocardial infarction with ST-segment elevation. The trial included 712 patients at 48 medical centers. The primary end point was target-vessel failure at 1 year after the procedure, defined as target-vessel-related death, recurrent myocardial infarction, or target-vessel revascularization. A follow-up angiographic substudy was performed at 8 months among 174 patients from selected centers. RESULTS: The rate of the primary end point was significantly lower in the sirolimus-stent group than in the uncoated-stent group(7.3%vs. 14.3%, P=0.004). This reduction was driven by a decrease in the rate of target-vessel revascularization(5.6%and 13.4%, respectively; P< 0.001). There was no significant difference between the two groups in the rate of death(2.3%and 2.2%, respectively; P=1.00), reinfarction(1.1%and 1.4%, respectively; P=1.00), or stent thrombosis(3.4%and 3.6%, respectively; P=1.00). The degree of neointimal proliferation, as assessed by the mean(±SD)in-stent late luminal loss, was significantly lower in the sirolimus-stent group(0.14±0.49 mm vs. 0.83±0.52 mm in the uncoated stent group; P< 0.001). CONCLUSIONS: Among selected patients with acute myocardial infarction, the use of sirolimus-eluting stents significantly reduced the rate of target-vessel revascularization at 1 year.
