Real world effectiveness of PCSK-9 inhibitors combined with statins
versus statins among patients with very high risk of atherosclerotic
cardiovascular disease in China (RWE-PCSK study)
Abstract
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.