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首页> 外文期刊>Archives of cardiovascular diseases. Supplements >Ticagrelor versus clopidogrel: PLATO study The methodologist point of view [Ticagrélor versus clopidogrel: étude PLATO Le point de vue du méthodologiste]
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Ticagrelor versus clopidogrel: PLATO study The methodologist point of view [Ticagrélor versus clopidogrel: étude PLATO Le point de vue du méthodologiste]

机译：替卡格雷与氯吡格雷：PLATO研究方法论者的观点

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The PLATO study, which evaluated ticagrelor for acute coronary syndromes, is exemplary for both its results and its methodology. Ticagrelor was tested in a wide target population (myocardial infarction [MI] with or without ST elevation) within the various therapeutic strategies used in this setting (invasive procedure or not). To be indisputable, the effect of ticagrelor on the first main objective (number of deaths from vascular causes, MIs or strokes) must be more specifically consolidated within an invasive procedure corresponding to the second main objective of the study (number of major bleeding events). The PLATO study is of the quality required for a pivotal study, with concealment of the randomization, a double-blind follow-up, a central and blind assessment of the clinical events and the use of an intention-to-treat analysis. Some specific methodological techniques were used to analyze the two main objectives and to assess several evaluation criteria without needing to adjust the level of the first-order risk and so increase the number of subjects. The randomization was stratified on the intention to perform a percutaneous coronary intervention and the conclusions were considered significant only if the results of two main criteria were significant. Furthermore, a hierarchical model was used for the analysis of the secondary evaluation criteria. The PLATO study, with 33 subgroup analyses, is a model to approach the principles, the interests and the limitations of this type of analysis. Finally, the PLATO study is a perfectly driven and analyzed study, allowing one to conclude, without any bias, on the benefits of ticagrelor in acute coronary syndromes.
机译：PLATO研究评估替卡格雷对急性冠脉综合征的疗效，是其结果和方法学的典范。在此环境下使用的各种治疗策略（有无侵入性手术）中，在广泛的目标人群（有或没有ST抬高的心肌梗塞[MI]）中测试了替卡格雷洛。毋庸置疑，替卡格雷对第一个主要目标（因血管原因，心梗或中风导致的死亡人数）的影响必须更具体地纳入与研究的第二个主要目标（重大出血事件的数目）相对应的侵入性手术中。 PLATO研究具有关键研究所需的质量，包括隐藏随机分组，双盲随访，对临床事件的集中和盲评估以及使用意向性治疗分析。一些特定的方法技术被用来分析这两个主要目标并评估多个评估标准，而无需调整一级风险的水平，从而增加了受试者的数量。根据进行经皮冠状动脉介入治疗的意图对随机分组进行分层，只有在两个主要标准的结果均显着的情况下，结论才被认为是显着的。此外，使用了层次模型来分析二级评估标准。 PLATO研究具有33个亚组分析，是一种处理此类分析的原理，兴趣和局限性的模型。最后，PLATO研究是一项完美的，经过分析的研究，可以使人们在没有任何偏见的情况下得出替卡格雷在急性冠脉综合征中的益处。

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