Aims We assessed the impact of the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab on acute arterial events across all vascular territories, including coronary, cerebrovascular, and peripheral vascular beds, in patients with established atherosclerotic cardiovascular disease (ASCVD). Methods and results In the FOURIER trial, 27 564 patients with stable ASCVD on statin therapy were randomly assigned to evolocumab or placebo. Acute arterial events were a composite of acute coronary (coronary heart disease death, myocardial infarction, or urgent coronary revascularization), cerebrovascular (ischaemic stroke, transient ischaemic attack, or urgent cerebral revascularization), or peripheral vascular (acute limb ischaemia, major amputation, or urgent peripheral revascularization) events. Of the 2210 first acute arterial events, 74% were coronary, 22% were cerebrovascular, and 4% were peripheral vascular. Evolocumab reduced first acute arterial events by 19% (hazard ratio [HR] 0.81 [95% confidence interval 0.74–0.88]; P < 0.001), with significant individual reductions in acute coronary (HR 0.83 [0.75–0.91]), cerebrovascular (HR 0.77 [0.65–0.92]), and peripheral vascular (HR 0.58 [0.38–0.88]) events. There were 3437 total events (first plus recurrent), with evolocumab reducing total events by 24% (incidence rate ratio 0.76 [0.69–0.85]). The magnitude of reduction in acute arterial events with evolocumab numerically increased over time, with a 16% reduction (HR 0.84 [0.75–0.95]) in the first year followed by a 24% reduction (HR 0.76 [0.67–0.85]) thereafter. Conclusion The addition of the PCSK9 inhibitor evolocumab to statin therapy reduced acute arterial events across all vascular territories with a robust effect over time, indicating a pan-vascular impact of aggressive lipid-lowering therapy on these acute and clinically meaningful events. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01764633.

中文翻译：

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evolocumab 对所有血管区域急性动脉事件的影响：FOURIER 试验结果

目的 我们评估了前蛋白转化酶枯草杆菌蛋白酶 - kexin 9 型 (PCSK9) 抑制剂 evolocumab 对已确诊动脉粥样硬化性心血管疾病 (ASCVD) 患者所有血管区域（包括冠状动脉、脑血管和外周血管床）的急性动脉事件的影响。方法和结果 在 FOURIER 试验中，27564 名接受他汀类药物治疗的稳定 ASCVD 患者被随机分配到 evolocumab 组或安慰剂组。急性动脉事件是由急性冠状动脉（冠心病死亡、心肌梗死或紧急冠状动脉血运重建）、脑血管（缺血性中风、短暂性脑缺血发作或紧急脑血管重建）或外周血管（急性肢体缺血、大截肢、或紧急外周血运重建）事件。在 2210 例首次急性动脉事件中，74%为冠状动脉，22%为脑血管，4%为外周血管。Evolocumab 将首次急性动脉事件减少了 19%（风险比 [HR] 0.81 [95% 置信区间 0.74-0.88]；P < 0.001），急性冠状动脉（HR 0.83 [0.75-0.91]）、脑血管事件显着减少（HR 0.77 [0.65–0.92]）和外周血管（HR 0.58 [0.38–0.88]）事件。共有 3437 起事件（首次加复发），evolocumab 使总事件减少了 24%（发生率比 0.76 [0.69-0.85]）。随着时间的推移，evolocumab 对急性动脉事件的减少幅度在数值上有所增加，第一年减少了 16%（HR 0.84 [0.75-0.95]），随后减少了 24%（HR 0.76 [0.67-0.85]）。结论 在他汀类药物治疗中添加 PCSK9 抑制剂 evolocumab 可减少所有血管区域的急性动脉事件，并且随着时间的推移具有强大的效果，表明积极降脂治疗对这些急性和临床有意义的事件具有泛血管影响。临床试验注册网址：https://www.clinicaltrials.gov。唯一标识符：NCT01764633。