在接受经皮冠状动脉介入治疗的急性冠状动脉综合征和多支血管疾病患者中，早期加用依洛尤单抗至他汀类药物治疗。
Early Addition of Evolocumab to Statin Treatment in Patients with Acute Coronary Syndrome and Multivessel Disease Undergoing Percutaneous Coronary Intervention.
作者信息
Zhang Yahao, Zhang Anjian, Wu Yong, Zhang Yanghui, Hu Weiwei, Chen Penglei, Chen Kui, Ding Jiandong
机构信息
Department of Cardiology, Zhongda Hospital, Southeast University, 210009 Nanjing, Jiangsu, China.
Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, 450052 Zhengzhou, Henan, China.
出版信息
Rev Cardiovasc Med. 2023 Sep 25;24(9):270. doi: 10.31083/j.rcm2409270. eCollection 2023 Sep.
BACKGROUND
Evolocumab has been demonstrated to significantly reduce ischemic cardiovascular events in patients with stable coronary heart disease. However, it is currently unclear whether this benefit extends to patients with acute coronary syndrome (ACS) and multivessel disease (MVD) undergoing percutaneous coronary intervention (PCI). The objective of this study was to assess the safety, efficacy and feasibility of the early addition of evolocumab to statin treatment for ACS patients with MVD undergoing PCI.
METHODS
The authors conducted a multicenter, retrospective cohort study involving 1199 ACS patients with MVD undergoing PCI and with elevated low-density lipoprotein cholesterol (LDL-C) levels. Patients were divided into an evolocumab group or a standard-of-care group based on evolocumab use or not. The 18-month primary efficacy endpoint was a composite of ischemic stroke, death from cardiac causes, recurrent myocardial infarction (MI), unplanned coronary revascularization or unstable angina requiring hospitalization. The principal secondary efficacy endpoint was a composite of ischemic stroke, death from cardiac causes or recurrent MI.
RESULTS
After propensity score matching, the addition of evolocumab to statin treatment lowered LDL-C levels by 42.62% compared with statin therapy alone at 18 months, from a mean baseline level of 3.37-0.75 mmol/L ( 0.001). Relative to standard therapy, evolocumab added to statins was associated with significant reductions in the primary efficacy endpoint (8.3% . 13.3%; adjusted hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.39 to 0.91; = 0.017) and the principal secondary efficacy endpoint (6.1% . 10.2%; adjusted HR, 0.61; 95% CI, 0.37 to 0.99; = 0.048) after multivariable Cox regression adjustment. The treatment effect of evolocumab was consistent across all prespecified subgroups. There were no significant between-group differences in terms of adverse events.
CONCLUSIONS
In ACS patients with MVD taken for PCI, early initiation of evolocumab along with statin treatment was associated with a significant reduction in LDL-C levels and a reduced risk of recurrent cardiovascular events.
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trials Registry, identifier ChiCTR2000035165. Date: 2 August 2020. URL: https://www.chictr.org.cn/.
背景
已证明依洛尤单抗可显著降低稳定型冠心病患者的缺血性心血管事件。然而，目前尚不清楚这种益处是否适用于接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）和多支血管疾病（MVD）患者。本研究的目的是评估在接受PCI的ACS合并MVD患者中，早期在他汀类药物治疗基础上加用依洛尤单抗的安全性、有效性和可行性。
方法
作者进行了一项多中心回顾性队列研究，纳入1199例接受PCI且低密度脂蛋白胆固醇（LDL-C）水平升高的ACS合并MVD患者。根据是否使用依洛尤单抗将患者分为依洛尤单抗组或标准治疗组。18个月的主要疗效终点是缺血性卒中、心源性死亡、复发性心肌梗死（MI）、非计划性冠状动脉血运重建或因不稳定型心绞痛住院的复合终点。主要次要疗效终点是缺血性卒中、心源性死亡或复发性MI的复合终点。
结果
倾向评分匹配后，与单纯他汀类治疗相比，在他汀类治疗基础上加用依洛尤单抗在18个月时可使LDL-C水平降低42.62%，从平均基线水平3.37降至0.75 mmol/L（P<0.001）。多变量Cox回归调整后，与标准治疗相比，他汀类药物加用依洛尤单抗可使主要疗效终点显著降低（8.3%对13.3%；调整后风险比[HR]，0.60；95%置信区间[CI]，0.39至0.91；P = 0.017），主要次要疗效终点也显著降低（6.1%对10.2%；调整后HR，0.61；95%CI，0.37至0.99；P = 0.048）。依洛尤单抗的治疗效果在所有预先指定的亚组中均一致。两组在不良事件方面无显著差异。
结论
在接受PCI的ACS合并MVD患者中，早期开始依洛尤单抗联合他汀类治疗可显著降低LDL-C水平，并降低心血管事件复发风险。
临床试验注册
中国临床试验注册中心，标识符ChiCTR2000035165。日期：2020年8月2日。网址：https://www.chictr.org.cn/
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