Zhang Lei, Li Yuan-Yuan, Liu Xue-Hui, Liu Hong-Jun, Xu Qiang
Department of Cardiology, Yichang Hospital of Traditional Chinese Medicine, Yichang, China.
Traditional Chinese Medicine Hospital of China Three Gorges University, China Three Gorges University, Yichang, China.
PLoS One. 2025 Aug 8;20(8):e0329676. doi: 10.1371/journal.pone.0329676. eCollection 2025.
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new class of drugs used for the treatment of dyslipidemia. PCSK9 inhibitors have been shown to remarkably reduce cardiovascular events in patients at high risk, but data on their impact on sudden cardiac death (SCD) and ventricular arrhythmias are limited. This study aimed to evaluate whether PCSK9 inhibitor therapy reduces the risk of SCD and ventricular arrhythmias. METHODS: PubMed and Embase were searched up to September 1, 2024 and combined with data from ClinicalTrials.gov. Randomized controlled trials of PCSK9 inhibitors with ≥ 450 patients and follow-up of ≥ 48 weeks were considered for inclusion. Primary outcomes were the incidence of SCD and ventricular arrhythmias. We used a random-effects model to synthesize the data, calculating risk ratio (RR) and 95% confidence intervals (CI). Heterogeneity between studies was assessed with I² statistics. Risk of bias was assessed using the Cochrane risk of bias tool. RESULTS: A total of 12 articles with 16 trials involving 90,764 patients were included. The follow-up duration ranged from 48 weeks to 3.4 years. PCSK9 inhibitor therapy did not significantly reduce the risk of SCD (RR 0.83, 95% CI 0.54-1.28; P = 0.40; I2 = 0%), ventricular arrhythmias (RR 0.81, 95% CI 0.60-1.09; P = 0.17; I2 = 0%), and cardiac arrest (RR 1.20, 95% CI 0.61-2.33; P = 0.60; I2 = 0%). CONCLUSION: PCSK9 inhibitor therapy did not significantly reduce the risk of SCD and ventricular arrhythmias.
背景：前蛋白转化酶枯草溶菌素/kexin 9型（PCSK9）抑制剂是一类用于治疗血脂异常的新型药物。PCSK9抑制剂已被证明可显著降低高危患者的心血管事件，但关于其对心源性猝死（SCD）和室性心律失常影响的数据有限。本研究旨在评估PCSK9抑制剂治疗是否能降低SCD和室性心律失常的风险。 方法：检索截至2024年9月1日的PubMed和Embase，并结合来自ClinicalTrials.gov的数据。纳入PCSK9抑制剂的随机对照试验，试验患者≥450例，随访≥48周。主要结局是SCD和室性心律失常的发生率。我们使用随机效应模型对数据进行综合分析，计算风险比（RR）和95%置信区间（CI）。采用I²统计量评估研究间的异质性。使用Cochrane偏倚风险工具评估偏倚风险。 结果：共纳入12篇文章，包含16项试验，涉及90764例患者。随访时间从48周至3.4年。PCSK9抑制剂治疗未显著降低SCD风险（RR 0.83，95% CI 0.54 - 1.28；P = 0.40；I² = 0%）、室性心律失常风险（RR 0.81，95% CI 0.60 - 1.09；P = 0.17；I² = 0%）和心脏骤停风险（RR 1.20，95% CI 0.61 - 2.33；P = 0.60；I² = 0%）。 结论：PCSK9抑制剂治疗未显著降低SCD和室性心律失常的风险。
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