“介入无置入”时代临床试验替代终点的选择与统计学考虑
刘小云,赵延延,朱熠冰,李思冬,尹潞,徐波,李卫,王杨
摘要(Abstract):
<正>自21世纪初,经皮冠状动脉介入治疗(percutaneous coronary intervention, PCI)心血管疾病的年手术量已逼近八百万的数量级,按2001年开展的577 767例计算,相当于在每100万人口中有1108例进行PCI术,且该数字以每年15%~25%的速度持续增长~([1])。药物洗脱支架(drug-eluting stent, DES)凭借其对支架内再狭窄的有效控制,成为当前PCI的"金标准"~([2])。但有研究表明,DES置入可能导致动脉粥样硬化过程加速、炎症反应和支架小梁断裂等风险~([3])。
关键词(KeyWords): 主要终点;晚期管腔丢失;药物洗脱球囊;全降解支架;介入无置入
基金项目(Foundation): 中国医学科学院医学与健康科技创新工程经费资助(2016-12M-2-004)
作者(Author): 刘小云,赵延延,朱熠冰,李思冬,尹潞,徐波,李卫,王杨
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