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背景:尽管随机研究已表明药物洗脱支架(DES)可减少再次血运重建的风险,但其是否降低心肌梗死和死亡发生率尚不得而知。近期,DES的长期安全性已受到质疑。方法:对比较评价裸金属支架(BMS)与DES安全性的4项随机试验中共1748例患者进行汇总分析。患者资料由2所学术机构中独立的统计学专家进行采集和分析。主要安全性终点为4年生存率。对不同亚组患者治疗反应的异质性进行检验。
BACKGROUND: Although randomized studies have shown that drug-eluting stents (DES) reduce the risk of revascularization, it is not known whether DES can reduce the incidence of MI and death. The long-term security of DES has been questioned recently. Methods: A total of 1748 patients from 4 randomized trials evaluating the safety of bare metal stents (BMS) and DES were pooled for analysis. Patient data were collected and analyzed by independent statistical experts from two academic institutions. The primary safety endpoint is 4-year survival. Heterogeneity of response to treatment in different subgroups was tested.