急性冠状动脉综合征后他汀类药物治疗患者中PCSK9抑制剂的安全性和有效性及其对冠状动脉斑块表型的影响：一项系统评价和荟萃分析

Safety and efficacy of PCSK9 inhibitors and effect on coronary plaque phenotype in statin-treated patients following acute coronary syndrome: a systematic review and meta-analysis.

作者信息

Hakim Dennis Ievan, Qhabibi Faqrizal Ria, Yusuf Muhammad, Amar Nasim, Prasetya Indra, Ambari Ade Meidian

机构信息

Medical School Department, Faculty of Medicine, Brawijaya University, Jl. Veteran, Lowokwaru, Malang, 65145, Indonesia.

Department of Cardiovascular Prevention and Rehabilitation, National Cardiovascular Center Harapan Kita, West Jakarta, Jakarta, Indonesia.

出版信息

Egypt Heart J. 2024 Oct 4;76(1):135. doi: 10.1186/s43044-024-00567-2.

DOI:10.1186/s43044-024-00567-2

PMID:39365518

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11452574/

Abstract

BACKGROUND

Acute coronary syndrome continues to be a significant cardiovascular issue. Statins are commonly acknowledged as medications that reduce LDL-C levels and stabilize plaques. Nevertheless, their efficacy is limited. Presently, PCSK9 inhibitors are suggested to be advantageous in patients who are already receiving statin treatment. The study seeks to assess the safety and effectiveness of PCSK9 inhibitors in individuals who have been treated with statins after experiencing acute coronary syndrome (ACS), as well as investigate the impact on the characteristics of coronary plaque.

METHODS

Articles were identified from PubMed, Cochrane Central Register of Controlled Trials, and ProQuest. Our analysis comprised trials and observational studies that compared the plaque phenotype, lipid profile, and safety outcomes between PCSK9 inhibitors and a control group in patients with acute coronary syndrome who were already being treated with statins. The random-effect model was used to measure the pooled effect, which was presented in terms of mean difference, standardized mean difference, and risk ratio.

RESULTS

Acquired 12 studies that fulfilled our criteria. The addition of PCSK9 inhibitors ameliorates the plaque phenotype significantly in terms of percent atheroma volume (P = 0.02), total atheroma volume (P < 0.010), fibrous cap thickness (P < 0.00001), lipid arc (P < 0.00001), quantitative flow ratio (P = 0.003), and diameter of stenosis (P = 0.0003) but not in lipid/lesion length (P = 0.17). The administration of PCSK9 inhibitors led to a considerable improvement in all lipid profiles (P < 0.00001). Regarding safety analysis, there is no substantial disparity in the likelihood of non-serious side events (RR 1.21; P = 0.2), however, a significant reduction in the risk of serious adverse effects (RR 0.77; P = 0.04) in the PCSK9 inhibitor group.

CONCLUSIONS

The addition of PCSK9 inhibitors compared to statin-only treatment led to a majority of patients experiencing significant benefits in terms of safety and efficacy following ACS.

摘要

背景

急性冠状动脉综合征仍然是一个重要的心血管问题。他汀类药物通常被认为是降低低密度脂蛋白胆固醇（LDL-C）水平和稳定斑块的药物。然而，它们的疗效有限。目前，前蛋白转化酶枯草溶菌素9（PCSK9）抑制剂被认为对已经接受他汀类药物治疗的患者有益。本研究旨在评估PCSK9抑制剂在急性冠状动脉综合征（ACS）后接受他汀类药物治疗的个体中的安全性和有效性，并研究其对冠状动脉斑块特征的影响。

方法

从PubMed、Cochrane对照试验中央登记库和ProQuest中检索文章。我们的分析包括比较PCSK9抑制剂与对照组在已接受他汀类药物治疗的急性冠状动脉综合征患者中的斑块表型、血脂谱和安全性结果的试验和观察性研究。采用随机效应模型测量合并效应，以平均差、标准化平均差和风险比表示。

结果

获得了12项符合我们标准的研究。添加PCSK9抑制剂在斑块体积百分比（P = 0.02）、总斑块体积（P < 0.010）、纤维帽厚度（P < 0.00001）、脂质弧（P < 0.00001）、定量血流比（P = 0.003）和狭窄直径（P = 0.0003）方面显著改善了斑块表型，但在脂质/病变长度方面没有改善（P = 0.17）。PCSK9抑制剂的使用导致所有血脂谱有显著改善（P < 0.00001）。关于安全性分析，非严重不良事件的可能性没有实质性差异（风险比1.21；P = 0.2），然而，PCSK9抑制剂组严重不良反应的风险显著降低（风险比0.77；P = 0.04）。