OBJECTIVES: Hypercholesterolemia, especially elevated levels of low-density lipoprotein cholesterol (LDL-C), is a major risk factor for ASCVD. Despite the irreplaceable role of statins in lowering lipids and cardiovascular benefit, over 50% of patients still do not achieve the lipid target. The clinical application of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represents a significant breakthrough in the field of lipid management. This study employed a Meta-analysis to systematically evaluate the lipid-lowering efficacy and safety of PCSK9i in patients with ACS.

METHODS: A systematic search and review of the PubMed literature database was performed.

RESULTS: 7 articles involving 19,574 patients were included in this study. The experimental group received either evolocumab or alirocumab plus standard background therapy, while the control group was treated with statins, statins combined with other lipid-lowering drugs, or other standard background therapies. In terms of efficacy, PCSK9 monoclonal antibodies further reduced the levels of LDL-C (SMD=-1.886, 95%CI: [-3.104, -0.667], P=0.002), triglycerides (TG) (SMD=-0.844, 95%CI: [-0.981, -0.708], P=0.000), and total cholesterol (TC) (SMD=-2.092, 95%CI: [-2.909, -1.276], P=0.000) on top of statins with statistical significance; however, changes in high-sensitivity C-reactive protein (hsCRP) (SMD=-6.654, 95%CI: [-15.968, 2.660], P=0.161) and high-density lipoprotein cholesterol (HDL-C) levels (SMD=-0.080, 95%CI: [-0.379, 0.218], P=0.599) showed no statistically significant difference compared to the control group. Regarding safety, compared with the control group, PCSK9 inhibitors did not significantly reduce the risk of adverse cardiovascular events in ACS patients (RR=0.952, 95%CI: [0.800, 1.133], P=0.581).

CONCLUSIONS: PCSK9 monoclonal antibodies can further decrease LDL-C levels and simultaneously improve TG and TC metabolism. In terms of safety, there was no statistically significant difference in the incidence of cardiovascular adverse events between the experimental and control groups. However, given the small number and quality variations among the included studies, the above conclusions still need to be confirmed by large-scale, high-quality randomized controlled trials.