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. 2021 Apr 28;18(4):261-270.
doi: 10.11909/j.issn.1671-5411.2021.04.005.

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

Yu-Qi Liu  1 , Dan-Dan Li  1 , Meng Chai  2 , Hong-Liang Cong  3 , Xiao-Qiang Cong  4 , Jun Dai  5 , Rong-Pin DU  6 , Ming Gao  7 , Jin-Cheng Guo  8 , Yan-Qing Guo  9 , Xiao-Jian Hong  10 , Rong-Chong Huang  11 , Feng-Shun Jia  12 , Jia-Yu Li  13 , Qing Li  14 , Jia-Mei Liu  15 , Xin-Ping Liu  14 , Yu-Guo Liu  16 , Hong-Gang Nie  17 , Bing Shao  18 , Xiao-Yu Shen  19 , Hai-Qing Song  20 , Yi-Jun Song  21 , Li-Jun Wang  22 , Shuo Wang  23 , Dong-Mei Wu  24 , Jing Xia  25 , Zhi-Yong Yang  26 , Hong-Ying Yu  27 , Hui Zhang  28 , Tie-Mei Zhang  29 , Ji-Yi Zhao  30 , Liang-Chen Zhao  31 , Ming-Qi Zheng  32 , Yun-Dai Chen  1
Affiliations

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

Yu-Qi Liu et al. J Geriatr Cardiol. .

Abstract

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.

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Figures

Figure 1
Figure 1
The overall patient treated with statins and goal LDL-C level in the real world.
Figure 2
Figure 2
The flow chart of patients.
Figure 3
Figure 3
Comparison of lipid profile before and after imitation of PCSK-9 inhibitor and statins treatment groups.
Figure 4
Figure 4
Kaplan-Meier curves of major adverse cardiovascular events.
Figure 5
Figure 5
Hazard ratios of using PCSK-9 inhibitor for MACE and other events.
See this image and copyright information in PMC

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