Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, People's Republic of China.
Adv Ther. 2021 Apr;38(4):1801-1810. doi: 10.1007/s12325-021-01662-5. Epub 2021 Feb 27.
The SECURE-PCI study supports a perioperative loading dose of statins, although whether an intensive lipid-lowering strategy prior to percutaneous coronary intervention further benefits acute coronary syndrome patients remains controversial. Evolocumab, a proprotein-converting enzyme subtilisin/kexin type 9 (PCSK9) inhibitor, acts more quickly and effectively than statins and reduces the risk of cardiovascular events in post-myocardial infarction (MI) patients. Nonetheless, whether it can be safely used in perioperative MI patients and whether perioperative application can benefit patients are still unknown. This study aims to evaluate the safety and efficacy of this treatment regimen.
A multicentre, prospective, randomized, controlled superiority trial will be conducted in 530 statin-naïve MI patients. All eligible patients will be randomized to the evolocumab group (140 mg subcutaneously injected once before revascularization + 14 days after the first dose) or the control group (no evolocumab injection). Evolocumab will then be administered depending on the patient's lipid profile. Both groups will be treated simultaneously with standardized secondary preventive medications. The primary end points are major adverse cardiovascular events (a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischaemic causes) within 12 months. The secondary end point is post-infarction angina after pain relief. The safety end points include myopathy, impaired liver or renal function, and other adverse events during the follow-up period.
This is the first trial to evaluate the safety and efficacy of evolocumab pre-treatment on prognosis in MI patients. Perioperative evolocumab injection may be a new, safe way to improve prognosis.
Chinese Clinical Trial Registry ( http://www.chictr.org.cn ; ChiCTR1900024526). Registered on 13 July 2019 and updated on 31 May 2020. The study is currently recruiting patients.
SECURE-PCI 研究支持他汀类药物的围手术期负荷剂量，尽管经皮冠状动脉介入治疗前强化降脂策略是否使急性冠状动脉综合征患者进一步获益仍存在争议。依洛尤单抗是一种前蛋白转化酶枯草溶菌素/克那霉 9（PCSK9）抑制剂，作用快、效果强于他汀类药物，并且降低心肌梗死后（MI）患者的心血管事件风险。然而，它在围手术期 MI 患者中是否能够安全使用以及围手术期应用是否能使患者获益尚不清楚。本研究旨在评估这种治疗方案的安全性和疗效。
一项多中心、前瞻性、随机、对照优势试验将在 530 例他汀类药物初治的 MI 患者中进行。所有符合条件的患者将被随机分为依洛尤单抗组（在血运重建前皮下注射 140mg 一次+首次剂量后 14 天）或对照组（不注射依洛尤单抗）。然后将根据患者的血脂谱给予依洛尤单抗。两组同时给予标准化二级预防药物治疗。主要终点是 12 个月内主要不良心血管事件（死亡、再发心肌梗死、意外血运重建、卒中和任何因缺血原因再次住院的复合终点）。次要终点是疼痛缓解后梗死后心绞痛。安全性终点包括肌病、肝肾功能受损和随访期间的其他不良事件。
这是第一项评估 MI 患者依洛尤单抗预处理对预后安全性和疗效的试验。围手术期依洛尤单抗注射可能是改善预后的一种新的、安全的方法。
中国临床试验注册中心（http://www.chictr.org.cn；ChiCTR1900024526）。于 2019 年 7 月 13 日注册，于 2020 年 5 月 31 日更新。目前正在招募患者。
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