yuqi liu

and 34 more

Background The efficacy and safety of PCSK-9 inhibitors were confirmed by several clinical trials, but its effectiveness in routine clinical practice in China is unknown. Objective To describe the real world effectiveness of initiated with PCSK-9 inhibitors combined with statins compared with statins among patients with very high risk of ASCVD and underwent percutaneous coronary intervention (PCI). Methods This is a prospective study, enrolled patients from 32 hospitals between January to June 2019. The lipid control rate and incidence of cardiovascular events over 6 months were compared between two groups. A propensity score-matched analysis was used to balance two groups on confounding factors. Survival analysis using Kaplan-Meier methods was applied for cardiovascular events. Results In a total of 3063 patients, 89.91% had received moderate or high-intensity statin therapy before PCI, but only 9.47% had LDL levels below 1.4mmol/L at baseline. In the PSM selected patients, LDL level was reduced by 42.57% in PCSK-9 inhibitor group and 30.81% (P<0.001) in statins group after 6 months. The proportion of LDL≤1.0mmol/L increased from 5.29% to 29.26% in PCSK-9 inhibitor group and 0.23% to 6.11% in statins group, and the proportion of LDL≤1.4mmol/L increased from 10.36% to 47.69% and 2.99% to 18.43% (P<0.001 for both). PCSK-9 inhibitor significantly reduced the incidence of cardiovascular events versus statins treatment (2.07% vs 8.29%, HR, 0.24, 95% CI, 0.12-0.51). Conclusion In the real world, PCSK-9 inhibitors combined with statins could significantly reduce LDL levels and risk of cardiovascular events among patients with very high risk of ASCVD.