摘要
背景:与裸金属支架相比,西罗莫司洗脱支架的长期疗效尚不清楚。方法:收集14项比较西罗莫司洗脱支架和裸金属支架的临床试验中4958例患者的资料(随访时间12.1～58.9个月)进行分析。主要终点事件为全因死亡,其他终点包括支架血栓形成、心肌梗死/死亡的联合终点以及再次介入/心肌梗死/死亡联合终点。结果:与裸金属支架组患者相比,西罗莫司洗脱支架组患者的死亡总风险(H R1.03,95%CI0.80～1.30)
BACKGROUND: The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established. METHODS: We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents(mean followup interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention. RESULTS: The overall risk of death(hazard ratio, 1.03; 95% confidence interval[CI], 0.80 to 1.30)and the combined risk of death or myocardial infarction(hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention(hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents(hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year. CONCLUSIONS: The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.
