Cardiovascular Department, the First Affiliated Hospital of Xi'an Jiaotong University, 277 West Yanta Road, Xi'an, 710061, Shaanxi, China.
Key Laboratory of Environment and Genes Related to Diseases, Ministry of Education, Xi'an, 710061, Shaanxi, China.
Lipids Health Dis. 2022 Oct 24;21(1):105. doi: 10.1186/s12944-022-01724-9.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitors among patients with acute myocardial infarction (AMI) based on real-world experience.
Data were collected from the Biobank of the First Affiliated Hospital of Xi'an Jiaotong University between January 2016 and December 2020. A total of 7556 AMI patients were screened for eligibility. Propensity Score Match (PSM) was employed, and covariates were age, sex, admission blood pressure and lipid profiles. Eligible participants were (1) propensity-matched 1:2:2 of statin plus evolocumab (dual therapy) vs. statin vs. statin plus ezetimibe. Ninety-five statin plus evolocumab users achieved significantly decreased low density lipoprotein (LDL) levels (0.92 ± 0.62 mmol/L in the 1st month and 1.17 ± 0.73 in the 3rd month) and a promising attainment rate of LDL (79.5% in the 1st month and 80.0% in the 3rd month) compared to the other two groups. (2) Propensity-matched 1:2:2 of statin plus ezetimibe evolocumab (triple therapy) vs. statin vs. statin plus ezetimibe. Similarly, 75 triple medication users achieved significantly decreased LDL levels and a promising attainment rate of LDL compared to the other two groups. In-hospital mortality and readmission rates within 3 months were then analyzed, and a decreased readmission rate was observed with PCSK9i therapy.
Based on the present single-center real-world PSM-adjusted study, PCSK9i has been effective in short-term lipid control among AMI patients. The long-term effectiveness for reducing major cardiovascular events among AMI patients based on real-world experience remains to be explored.
The study was registered at ClinicalTrials.gov, ClinicalTrials.gov ID: NCT05184530.
前蛋白转化酶枯草溶菌素 9（PCSK9）抑制剂在与常规他汀类药物联合使用时已被证明可改善心血管结局。本研究旨在根据真实世界经验，探讨急性心肌梗死（AMI）患者住院期间使用 PCSK9 抑制剂的疗效和安全性。
数据来自西安交通大学第一附属医院的生物库，时间范围为 2016 年 1 月至 2020 年 12 月。共筛选了 7556 例 AMI 患者，以确定其是否符合条件。采用倾向评分匹配（PSM），协变量包括年龄、性别、入院血压和血脂谱。符合条件的参与者（1）按他汀类药物+依洛尤单抗（双联治疗）、他汀类药物和他汀类药物+依折麦布的 1:2:2 进行倾向评分匹配；（2）按他汀类药物+依折麦布+依洛尤单抗（三联治疗）、他汀类药物和他汀类药物+依折麦布的 1:2:2 进行倾向评分匹配。95 例接受他汀类药物+依洛尤单抗治疗的患者在第 1 个月和第 3 个月的低密度脂蛋白（LDL）水平分别显著降低（0.92±0.62mmol/L 和 1.17±0.73mmol/L），且 LDL 达标率较高（第 1 个月为 79.5%，第 3 个月为 80.0%）。同样，75 例三联用药患者在第 1 个月和第 3 个月 LDL 水平显著降低，且 LDL 达标率较高。然后分析住院期间 3 个月内的死亡率和再入院率，发现 PCSK9i 治疗可降低再入院率。
基于目前的单中心真实世界 PSM 调整研究，PCSK9i 可有效控制 AMI 患者的短期血脂水平。基于真实世界经验，PCSK9i 对降低 AMI 患者主要心血管事件的长期效果仍有待探讨。
本研究在 ClinicalTrials.gov 注册，ClinicalTrials.gov 注册号：NCT05184530。
