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首页> 外文期刊>The New England journal of medicine >Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents.
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Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents.

机译：西罗莫司和紫杉醇洗脱冠状动脉支架的安全性和有效性。

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BACKGROUND: The safety of drug-eluting stents has been called into question by recent reports of increased stent thrombosis, myocardial infarction, and death. Such studies have been inconclusive because of their insufficient size, the use of historical controls, a limited duration of follow-up, and a lack of access to original source data. METHODS: We performed a pooled analysis of data from four double-blind trials in which 1748 patients were randomly assigned to receive either sirolimus-eluting stents or bare-metal stents and five double-blind trials in which 3513 patients were randomly assigned to receive either paclitaxel-eluting stents or bare-metal stents; we then analyzed the major clinical end points of the trials. RESULTS: The 4-year rates of stent thrombosis were 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20) and 1.3% in the paclitaxel-stent group versus 0.9% in the bare-metal-stent group (P=0.30). However, after 1 year, there were five episodes of stent thrombosis in patients with sirolimus-eluting stents versus none in patients with bare-metal stents (P=0.025) and nine episodes in patients with paclitaxel-eluting stents versus two in patients with bare-metal stents (P=0.028). The 4-year rates of target-lesion revascularization were markedly reduced in both the sirolimus-stent group and the paclitaxel-stent group, as compared with the bare-metal-stent groups. The rates of death or myocardial infarction did not differ significantly between the groups with drug-eluting stents and those with bare-metal stents. CONCLUSIONS: Stent thrombosis after 1 year was more common with both sirolimus-eluting stents and paclitaxel-eluting stents than with bare-metal stents. Both drug-eluting stents were associated with a marked reduction in target-lesion revascularization. There were no significant differences in the cumulative rates of death or myocardial infarction at 4 years.
机译：背景：最近关于支架血栓形成，心肌梗塞和死亡的报道增加了药物洗脱支架的安全性。由于其规模不足，使用历史对照，随访时间有限以及无法访问原始数据，因此此类研究尚无定论。方法：我们对来自四项双盲试验的数据进行了汇总分析，在该试验中，随机分配了1748例患者接受西罗莫司洗脱支架或裸金属支架，而在五项双盲试验中，随机分配了3513例患者来接受西罗莫司洗脱支架或裸金属支架紫杉醇洗脱支架或裸金属支架;然后，我们分析了试验的主要临床终点。结果：西罗莫司支架组的4年支架内血栓形成率为1.2％，裸金属支架组为0.6％（P = 0.20），紫杉醇支架组为1.3％，裸支架为0.9％ -金属支架组（P = 0.30）。然而，一年后，西罗莫司洗脱支架患者发生支架血栓发生五次，裸金属支架患者发生支架血栓发生（P = 0.025），紫杉醇洗脱支架患者发生支架血栓发生九次，裸金属支架患者发生两次-金属支架（P = 0.028）。与裸金属支架组相比，西罗莫司支架组和紫杉醇支架组的4年靶病变血运重建率显着降低。药物洗脱支架组和裸金属支架组的死亡率或心肌梗塞率无明显差异。结论：西罗莫司洗脱支架和紫杉醇洗脱支架在一年后的支架血栓形成比裸金属支架更为常见。两种药物洗脱支架均与靶病变血运重建显着减少有关。 4年时的累积死亡率或心肌梗塞率无显着差异。

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