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)
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）作者机构：Department of CardiologyChinese PLA General HospitalBeijingChina Department of CardiologyBeijing Anzhen HospitalCapital Medical UniversityBeijing Institute of Heart Lung and Blood Vessel DiseaseBeijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic DiseaseClinical Center for Coronary Heart DiseaseCapital Medical UniversityBeijingChina Department of CardiologyTianjin Chest HospitalTianjinChina Department of Cardiologythe First Hospital of Jilin UniversityChangchunChina Department of CardiologyFuwai HospitalNational Center for Cardiovascular DiseaseChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina Department of CardiologyHebei People’s HospitalShijiazhuangChina Department of CardiologyKailuan General HospitalHebei Union UniversityTangshanChina Department of CardiologyBeijing Luhe HospitalCapital Medical UniversityBeijingChina Department of CardiologyShanxi Cardiovascular HospitalTaiyuanChina Department of Cardiologythe Fourth Affiliated Hospital of Harbin Medical UniversityHarbinChina Department of CardiologyBeijing Friendship HospitalCapital Medical UniversityBeijingChina Department of CardiologyTangshan Worker’s HospitalTangshanChina Department of CardiologyChina-Japan Friendship Hospital Affiliated Jilin UniversityChangchunChina Department of CardiologyHandan Central HospitalHebeiChina Heart CenterBeijing Key Laboratory of HypertensionBeijing Chao-Yang HospitalCapital Medical UniversityBeijingChina Department of Cardiologythe First Affiliated Hospital of Dalian Medical UniversityLiaoningChina Department of Cardiologythe Second Affiliated Hospital of Harbin Medical UniversityHarbinChina Department of Cardiologythe Second Affiliated Hospital of Shenyang Medical CollegeShenyangChina Department of Cardiologythe Second Hospital of Shanxi Medical UniversityTaiyuanChina Department of NeurologyXuanwu Hospital Capital Medical UniversityBeijingChina Department of NeurologyTianjin Medical University General HospitalTianjinChina Department of Cardiologythe Third Hospital of Shijiazhuang CityShijiazhuangChina Department of Cardiologythe First Hospital of Shijiazhuang CityShijiazhuangChina Department of CardiologyTaigang General HospitalShanxi Medical UniversityTaiyuanChina Department of Cardiologythe Sixth Medical Center of Chinese PLA General HospitalBeijingChina Department of CardiologyShengjing Hospital of China Medical UniversityShengyangChina Department of CardiologyDaqing Oilfield General HospitalHeilongjiangChina Department of Cardiologythe Second Hospital of BaodingHebeiChina Department of Cardiology and Macrovascular DiseaseBeijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Cardiologythe First Affiliated Hospital of Harbin Medical UniversityHarbinChina Department of CardiologyJilin Central HospitalChangchunChina Heart Centerthe First Hospital of Hebei Medical UniversityShijiazhuangChina
出 版 物：《Journal of Geriatric Cardiology》 (老年心脏病学杂志（英文版）)
年 卷 期：2021年第18卷第4期
页 面：261-270页
核心收录：
学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学]
基 金：supported by the China Cardiovascular Health Alliance-Advanced Fund (2019CCA-ACCESS-054) the Beijing Lisheng Cardiovascular Health Foundation Pilot Fund Key Projects
主 题：LDL RWE-PCSK study Real world effectiveness of PCSK-9 inhibitors combined with statins versus statins-based therapy among patients with very high r
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 *** 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
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