The primary results of the FOURIER trial¹ showed that the significant reduction in cardiovascular events in the evolocumab group was driven by revascularisation—an endpoint that is to some extent discretionary²—and non-fatal myocardial infarction, without indicating how many of these infarctions were periprocedural events that might have a different prognostic significance to spontaneous myocardial infarctions. Furthermore, loss of masking to treatment allocation could have occurred because evolocumab predictably lowers LDL cholesterol, and decisions about revascularisations might have been biased by physicians who knew patients' lipid measurements.

中文翻译：

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质疑evolocumab的安全性和益处

FOURIER试验¹的主要结果表明，evolocumab组心血管事件的显着减少是由血运重建术（在某种程度上是可酌情决定的终点^2）和非致命性心肌梗死驱动的，而没有指出其中有多少次梗死对自发性心肌梗塞可能具有不同预后意义的围手术期事件。此外，由于依维洛单抗可预料地降低了LDL胆固醇，可能导致掩盖了治疗分配，并且有关血运重建的决定可能已被了解患者血脂测量值的医生所偏见。