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 LIU1
Dan-Dan LI1
Meng CHAI2
Hong-Liang CONG3
Xiao-Qiang CONG4
Jun DAI5
Rong-Pin DU6
Ming GAO7
Jin-Cheng GUO8
Yan-Qing GUO9
Xiao-Jian HONG10
Rong-Chong HUANG11
Feng-Shun JIA12
Jia-Yu LI13
Qing LI14
Jia-Mei LIU15
Xin-Ping LIU14
Yu-Guo LIU16
Hong-Gang NIE17
Bing SHAO18
Xiao-Yu SHEN19
Hai-Qing SONG20
Yi-Jun SONG21
Li-Jun WANG22
Shuo WANG23
Dong-Mei WU24
Jing XIA25
Zhi-Yong YANG26
Hong-Ying YU27
Hui ZHANG28
Tie-Mei ZHANG29
Ji-Yi ZHAO30
Liang-Chen ZHAO31
Ming-Qi ZHENG32
Yun-Dai CHEN1
1.Department of Cardiology, Chinese PLA General Hospital Beijing, China2.Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic Disease, Clinical Center for Coronary Heart Disease, Capital Medical University, Beijing, China3.Department of Cardiology, Tianjin Chest Hospital, Tianjin, China4.Department of Cardiology, the First Hospital of Jilin University, Changchun, China5.Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China6.Department of Cardiology, Hebei People's Hospital, Shijiazhuang, China7.Department of Cardiology, Kailuan General Hospital, Hebei Union University, Tangshan, China8.Department of Cardiology, Beijing Luhe Hospital Capital Medical University, Beijing, China9.Department of Cardiology, Shanxi Cardiovascular Hospital, Taiyuan, China10.Department of Cardiology, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, China11.Department of Cardiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China12.Department of Cardiology, Tangshan Worker's Hospital, Tangshan, China13.Department of Cardiology, China-Japan Friendship Hospital Affiliated Jilin University, Changchun, China14.Department of Cardiology, Handan Central Hospital, Hebei, China15.Heart Center, Beijing Key Laboratory of Hypertension, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China16.Department of Cardiology, the First Affiliated Hospital of Dalian Medical University, Liaoning, China17.Department of Cardiology, the Second Affiliated Hospital of Harbin Medical University, Harbin, China18.Department of Cardiology, the Second Affiliated Hospital of Shenyang Medical College, Shenyang, China19.Department of Cardiology, the Second Hospital of Shanxi Medical University, Taiyuan, China20.Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China21.Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China22.Department of Cardiology, the Third Hospital of Shijiazhuang City, Shijiazhuang, China23.Department of Cardiology, the First Hospital of Shijiazhuang City, Shijiazhuang, China24.Department of Cardiology, Taigang General Hospital, Shanxi Medical University, Taiyuan, China25.Department of Cardiology, the Sixth Medical Center of Chinese PLA General Hospital Beijing, China26.Department of Cardiology, Shengjing Hospital of China Medical University, Shengyang, China27.Department of Cardiology, Daqing Oilfield General Hospital, Heilongjiang, China28.Department of Cardiology, the Second Hospital of Baoding, Hebei, China29.Department of Cardiology and Macrovascular Disease, Beijing Tiantan Hospital, Capital Medical University, Beijing, China30.Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, China31.Department of Cardiology, Jilin Central Hospital, Changchun, China32.Heart Center, the First Hospital of Hebei Medical University, Shijiazhuang, China
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.
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论文发表日期：2021-04-28
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：10( 261-270 )