阿托伐他汀与瑞舒伐他汀用于肝酶升高的急性心肌梗死患者：一项目标试验模拟研究

Atorvastatin versus rosuvastatin in acute myocardial infarction with elevated liver enzymes: a target trial emulation study.

作者信息

Chen Xiaozhi, Liu Hangkuan, Li Linjie, A Geru, Sun Pengfei, Tan Doreen Su-Yin, Chan Mark Yan-Yee, Foo Roger Sik-Yin, Fonarow Gregg C, Yang Qing, Zhou Xin

机构信息

Department of Cardiology, Tianjin Medical University General Hospital, Tianjin Medical University, 154, Anshan Road, Heping District, Tianjin, 300052, China.

Department of Pharmacy and Pharmaceutical Sciences, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore.

出版信息

Clin Res Cardiol. 2025 Jun;114(6):796-808. doi: 10.1007/s00392-025-02645-0. Epub 2025 Apr 10.

DOI:10.1007/s00392-025-02645-0

PMID:40208301

Abstract

BACKGROUND

Statins are associated with liver-related adverse events, with risk varying by statin type. However, current guidelines lack specific recommendations for statin selection in acute myocardial infarction (AMI) patients with elevated liver enzymes.

METHODS

This cohort study used a target trial emulation approach to include AMI patients treated with percutaneous coronary intervention between 2013 and 2022 from the Tianjin Health and Medical Data Platform, China. Eligible patients with atorvastatin or rosuvastatin prescriptions during hospitalization were matched 1:1 using propensity scores in those with elevated liver enzymes and normal liver enzymes respectively, and tracked for 1 year or until death (intention-to-treat analysis). Nonadherent patients were censored in the per-protocol analysis. The primary outcome was 1-year all-cause mortality, with secondary outcomes including recurrent MI and stroke.

RESULTS

In a matched cohort of 25,728 patients with elevated liver enzymes, 614 deaths (2.4%) occurred. Atorvastatin was associated with higher all-cause mortality compared to rosuvastatin (hazard ratio [HR]: 1.29, 95% confidence interval [CI] 1.10-1.51), consistent in the per-protocol analysis, and the in-hospital mortality difference was confirmed in an independent cohort. No significant differences were observed for recurrent MI (HR: 0.98, 95% CI 0.87-1.11) or stroke (HR: 1.10, 95% CI 0.93-1.28). Similar target trial emulation design among 18,270 AMI patients with normal liver enzymes at admission (9135 per group) found no significant differences between the two statins in all-cause mortality (HR: 1.09, 95% CI 0.88-1.35), recurrent MI (HR: 1.05, 95% CI 0.90-1.23), or stroke (HR: 1.07, 95% CI 0.90-1.28).

CONCLUSIONS

Atorvastatin treatment was associated with a higher risk of 1-year all-cause mortality than Rosuvastatin in a target trial emulation study of patients with elevated liver enzymes following AMI.

摘要

背景

他汀类药物与肝脏相关不良事件有关，风险因他汀类药物类型而异。然而，目前的指南缺乏针对肝酶升高的急性心肌梗死（AMI）患者选择他汀类药物的具体建议。

方法

这项队列研究采用目标试验模拟方法，纳入了2013年至2022年来自中国天津健康与医疗数据平台接受经皮冠状动脉介入治疗的AMI患者。在住院期间开具阿托伐他汀或瑞舒伐他汀处方的符合条件患者，分别在肝酶升高和肝酶正常的患者中使用倾向评分进行1:1匹配，并随访1年或直至死亡（意向性分析）。在符合方案分析中，对未坚持治疗的患者进行截尾。主要结局是1年全因死亡率，次要结局包括复发性心肌梗死和中风。

结果

在25728例肝酶升高的匹配队列患者中，有614例死亡（2.4%）。与瑞舒伐他汀相比，阿托伐他汀与更高的全因死亡率相关（风险比[HR]：1.29，95%置信区间[CI] 1.10 - 1.51），在符合方案分析中一致，且在独立队列中证实了住院死亡率差异。复发性心肌梗死（HR：0.98，95% CI 0.87 - 1.11）或中风（HR：1.10，95% CI 0.93 - 1.28）未观察到显著差异。在18270例入院时肝酶正常的AMI患者中进行类似的目标试验模拟设计（每组9135例），发现两种他汀类药物在全因死亡率（HR：1.09，95% CI 0.88 - 1.35）、复发性心肌梗死（HR：1.05，95% CI 0.90 - 1.23）或中风（HR：1.07，95% CI 0.90 - 1.28）方面无显著差异。