中国非ST段抬高型急性冠状动脉综合征患者PCI术后早期应用依洛尤单抗的有效性及安全性研究  

Early initiation of evolocumab in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention

作　　者：张亚豪 张扬辉 陈鹏磊 张斌[1] 陈魁[1] ZHANG Yahao;ZHANG Yanghui;CHEN Penglei;ZHANG Bin;CHEN Kui(Department of Cardiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,450052,China)

机构地区：[1]郑州大学第一附属医院心血管内科,郑州450052

出　　处：《临床心血管病杂志》2022年第8期623-630,共8页Journal of Clinical Cardiology

摘　　要：目的:探讨非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者经皮冠状动脉介入治疗(PCI)后早期应用依洛尤单抗的有效性和安全性。方法:回顾性连续纳入2019年3月1日—2020年5月31日于郑州大学第一附属医院心血管内科确诊的NSTE-ACS、接受PCI治疗同时伴随高低密度脂蛋白胆固醇(LDL-C)水平的患者1263例(既往规律服用4周以上他汀类药物者LDL-C≥1.8 mmol/L;既往未服用或未规律服用他汀类药物者LDL-C≥3.0 mmol/L)。根据药物使用分为依洛尤单抗组(326例)和对照组(937例)。依洛尤单抗组患者于PCI术后院内早期应用依洛尤单抗(每2周皮下注射140 mg)。2组患者均规律使用他汀类药物治疗。收集2组患者基线以及出院后1、6、12、18个月的LDL-C水平。主要终点为随访18个月的心血管不良事件(包括心血管死亡、心肌梗死、缺血性卒中、因不稳定型心绞痛住院和冠状动脉血运重建在内的复合终点)。同时在8个预先设定的亚组中评估依洛尤单抗对主要终点的影响。结果:与对照组相比,依洛尤单抗联合他汀类药物在第18个月随访时可将LDL-C水平较基线降低42.54%。经多因素Cox回归校正后,在他汀治疗的基础上早期应用依洛尤单抗可显著降低主要终点事件发生率(7.7%vs 12.5%;HR=0.61;95%CI:0.40~0.94;P=0.025)。亚组分析表明,依洛尤单抗在各个亚组中可显著降低主要终点事件的发生率,该结果与总体分析一致。结论:在NSTE-ACS行PCI治疗的患者中,在他汀治疗的基础上早期联用依洛尤单抗可显著降低LDL-C水平及心血管事件的发生风险,其疗效持续且安全性良好。Objective: To evaluate the efficacy and safety of the early initiation of evolocumab in Chinese patients with non-ST-segment elevation acute coronary syndrome(NSTE-ACS)undergoing percutaneous coronary intervention(PCI).Methods: We performed a retrospective study involving 1263 consecutive patients with NSTE-ACS undergoing PCI,and who either had an LDL-C level of at least 1.8 mmol/L after receiving statins for more than 4 weeks or an LDL-C level of at least 3.0 mmol/L without regular statin treatment.They were divided into the evolocumab group(n=326)and the control group(n=937)according to whether evolocumab was used or not.Evolocumab was initiated in the hospital and administered for 18 months after discharge.All enrolled patients received regular statin treatment.LDL-C levels were measured at baseline and 1,6,12 and 18 months after discharge.The primary endpoint at 18 months was a composite of ischemic stroke,cardiovascular death,myocardial infarction,hospitalization for unstable angina or coronary revascularization.The effect of evolocumab on the primary endpoint was evaluated in 8 prespecified subgroups.Results: The addition of evolocumab to statin treatment lowered LDL-C levels by 42.54%from baseline compared with statins alone.Early initiation of evolocumab on a background of statin treatment was associated with a significant reduction in the primary endpoint(7.7%vs.12.5%;HR,0.61;95%CI,0.40~0.94;P=0.025).In subgroup analyses,the significant reduction in the primary endpoint with evolocumab treatment was consistent across all prespecified subgroups.Conclusion: Among Chinese patients with NSTE-ACS undergoing PCI,the early initiation of evolocumab on a background of statin therapy significantly lowered LDL-C levels and the risk of adverse cardiovascular events,with sustained efficacy and satisfactory safety.

关 键 词：非ST段抬高型急性冠状动脉综合征 依洛尤单抗 低密度脂蛋白胆固醇 经皮冠状动脉介入治疗 

分 类 号：R541.4[医药卫生—心血管疾病]