摘要BACKGROUND The efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitors were confirmed by several clinical trials,but its effectiveness in routine clinical practice in China has not been evaluated.This study aims to describe the real world effectiveness of PCSK-9 inhibitors combined with statins compared with statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease (ASCVD).METHODS This is a multi-center observational study,enrolled patients from 32 hospitals who underwent percutaneous coronary intervention (PCI) from January to June in 2019.There are 453 patients treated with PCSK-9 inhibitors combined with statins in PCSK-9 inhibitor group and 2,610 patients treated with statins-based lipid lowering therapies in statins-based group.The lipid control rate and incidence of major adverse cardiovascular events (MACE) over six months were compared between two groups.A propensity score-matched (PSM) analysis was used to balance two groups on confounding factors.Survival analysis using Kaplan-Meier methods was applied for MACE.RESULTS In a total of 3,063 patients,89.91％ of patients had received moderate or high-intensity statins-based therapy before PCI,but only 9.47％ of patients had low-density lipoprotein cholesterol (LDL-C) levels below 1.4 mmol/L at baseline.In the PSM selected patients,LDL-C level was reduced by 42.57％ in PCSK-9 inhibitor group and 30.81％ (P ＜ 0.001) in statins-based group after six months.The proportion of LDL-C ≤ 1.0 mmol/L increased from 5.29％ to 29.26％ in PCSK-9 inhibitor group and 0.23％ to 6.11％ in statins-based group,and the proportion of LDL-C ≤ 1.4 mmol/L increased from 10.36％ to 47.69％ in PCSK-9 inhibitor group and 2.99％ to 18.43％ in statins-based group (P ＜ 0.001 for both).There was no significant difference between PCSK-9 inhibitor and statins-based treatment in reducing the risk of MACE (hazard ratio =2.52,95％ CI: 0.49-12.97,P =0.250).CONCLUSIONS In the real world,PCSK-9 inhibitors combined with statins could significantly reduce LDL-C levels among patients with very high risk of ASCVD in China.The long-term clinical benefits for patients received PCSK-9 inhibitor to reduce the risk of MACE is still unclear and requires further study.