Clinical end points in coronary stent trials - A case for standardized definitions
Clinical end points in coronary stent trials - A case for standardized definitions
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DOI：
10.1161/circulationaha.106.685313
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发表时间：
2007-05-01
期刊：
影响因子：
37.8
通讯作者：
Serruys, Patrick W.
中科院分区：
文献类型：
--
作者：
Cutlip, Donald E.;Windecker, Stephan;Serruys, Patrick W.
背景 - 尽管大多数冠状动脉支架临床试验测量了名义上相同的安全性和有效性终点，但定义和评估时间的差异造成了解释上的混乱。方法和结果 - 学术研究联盟是美国和欧洲学术研究组织之间的非正式合作。两次会议分别于 2006 年 1 月在华盛顿特区和 2006 年 6 月在爱尔兰都柏林举行，会议由学术研究联盟主办，成员包括美国食品和药物管理局的代表以及与食品和药物管理局合作开展药物洗脱支架临床试验计划的所有设备制造商，会议重点讨论了药物洗脱支架评估的共识终点定义。这项工作的目标是建立终点定义之间的一致性并提供共识建议。在考虑历史遗产、关键病理生理机制以及与临床可解释性的相关性的基础上，制定了死亡、心肌梗死、重复血运重建和支架内血栓形成的评估标准。本文件中基础广泛的共识终点定义可有效应用或认可用于监管和临床试验目的。 结论 - 尽管共识标准将不可避免地包括某些任意特征，但临床终点的共识标准提供了跨研究的一致性，有助于评估这些设备的安全性和有效性。
Background - Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation.Methods and Results - The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes.Conclusion - Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.