Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Department of Cardiac Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Clin Ther. 2022 Jun;44(6):901-912. doi: 10.1016/j.clinthera.2022.04.010. Epub 2022 May 14.
Evolocumab has been shown to improve cardiovascular outcomes in patients with stable atherosclerotic disease. Whether this benefit persists in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) remains undetermined. This study aimed to evaluate the efficacy and safety of the early initiation of evolocumab in Chinese patients with ACS undergoing PCI.
This retrospective cohort study involved 1564 consecutive patients who had been hospitalized with ACS and underwent PCI, and who had elevated LDL-C levels (≥1.8 mmol/L after receiving high-intensity statin therapy for ≥4 weeks; ≥2.3 mmol/L after receiving low- or moderate-intensity statin; or ≥3.2 mmol/L without statin therapy). Patients who received evolocumab (initiated in-hospital and after 18 months) were included in the evolocumab group (n = 414), and all other patients were included in the control group (n = 1150). The primary outcome at 18 months was a composite of ischemic stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, or coronary revascularization. The evolocumab treatment effect on the primary outcome was assessed in all prespecified subgroups.
At 18 months, evolocumab combined with statins reduced LDL-C levels from baseline levels by 42.48% compared with statins alone. After multivariable adjustment, evolocumab combined with statins significantly reduced the primary outcome (8.2% vs 12.4%; adjusted hazard ratio, 0.65; 95% CI, 0.45-0.95; P = 0.025). In addition, evolocumab consistently reduced the primary outcome across the major subgroups. For the safety outcomes, no significant differences between the groups were observed in any adverse events.
Among Chinese patients who underwent PCI for ACS, the early initiation of evolocumab combined with statin treatment effectively reduced LDL-C levels and lowered the incidence of recurrent ischemic cardiovascular events, with satisfactory tolerability and safety. Chinese Clinical Trial Registry identifier: ChiCTR2100049364.
依洛尤单抗已被证明可改善稳定性动脉粥样硬化疾病患者的心血管结局。在接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）患者中，这种获益是否持续尚不确定。本研究旨在评估 ACS 患者 PCI 术后早期开始依洛尤单抗治疗的疗效和安全性。
这是一项回顾性队列研究，共纳入 1564 例因 ACS 住院并接受 PCI 治疗且 LDL-C 水平升高（高强度他汀治疗≥4 周后≥1.8mmol/L；低或中强度他汀治疗后≥2.3mmol/L；或未接受他汀治疗时≥3.2mmol/L）的连续患者。接受依洛尤单抗治疗（住院期间和 18 个月后开始）的患者被纳入依洛尤单抗组（n=414），所有其他患者被纳入对照组（n=1150）。18 个月时的主要终点是缺血性卒中、心血管死亡、心肌梗死、不稳定型心绞痛住院或冠状动脉血运重建的复合终点。在所有预先指定的亚组中评估了依洛尤单抗对主要终点的治疗效果。
18 个月时，与单独使用他汀类药物相比，依洛尤单抗联合他汀类药物使 LDL-C 水平从基线水平降低了 42.48%。经过多变量调整后，依洛尤单抗联合他汀类药物显著降低了主要终点事件（8.2% vs 12.4%；调整后的危险比，0.65；95%CI，0.45-0.95；P=0.025）。此外，依洛尤单抗在主要亚组中均一致降低了主要终点事件的发生率。在安全性结局方面，两组间任何不良事件均无显著差异。
在中国 ACS 患者 PCI 术后，早期开始依洛尤单抗联合他汀类药物治疗可有效降低 LDL-C 水平，降低复发性缺血性心血管事件的发生率，且耐受性和安全性良好。
ChiCTR2100049364。
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