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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)
  • +32
  • yuqi liu,
  • Dandan Li,
  • Meng Chai,
  • Hongliang Cong,
  • Xiaoqiang Cong,
  • Jun Dai,
  • Rongping Du,
  • Ming Gao,
  • Jincheng Guo,
  • Yanqing Guo,
  • Xiaojian Hong,
  • Rongchong Huang,
  • Fenshun Jia,
  • Jiayu Li,
  • Qing Li,
  • Jiamei Liu,
  • Xinping Liu,
  • Yuguo Liu,
  • Honggang Nie,
  • Bin Shao,
  • Xiaoyu Shen,
  • Haiqing Song,
  • Yijun Song,
  • Lijun Wang,
  • Shuo Wang,
  • Dongmei Wu,
  • Jin Xia,
  • Zhiyong Yang,
  • Hongying Yu,
  • Hui Zhang,
  • Tiemei Zhang,
  • Jiyi Zhao,
  • Liangchen Zhao,
  • Mingqi Zheng,
  • Yundai Chen
yuqi liu
Institute of Geriatric Cardiology

Corresponding Author:[email protected]

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Hongliang Cong
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Xiaoqiang Cong
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Rongping Du
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Jincheng Guo
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Yanqing Guo
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Xiaojian Hong
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Rongchong Huang
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Fenshun Jia
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Jiamei Liu
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Xinping Liu
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Honggang Nie
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Xiaoyu Shen
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Haiqing Song
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Yijun Song
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Lijun Wang
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Dongmei Wu
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Zhiyong Yang
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Hongying Yu
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Tiemei Zhang
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Liangchen Zhao
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Mingqi Zheng
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Yundai Chen
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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.