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FUNCTION研究:沙库巴曲缬沙坦对非阵发性心房颤动导管消融成功率影响的随机对照试验

The FUNCTION Study: A Randomized Controlled Trial on the Efficacy of Sacubitril/Valsartan on the Success Rate of Catheter Ablation for Nonparoxysmal Atrial Fibrillation.

作者信息

Li Wenhua, Feng Weixiang, Wang Juan, Song Yanbin, Liang Xiaofang, Xue Sheliang

机构信息

Department of Cardiology, Wujin Hospital Affiliated with Jiangsu University, Wujin Clinical College of Xuzhou Medical University, No. 2 Yongning North Road, Tianning District, Changzhou City, Jiangsu Province, China.

出版信息

Cardiovasc Drugs Ther. 2025 May 7. doi: 10.1007/s10557-025-07706-0.

DOI:10.1007/s10557-025-07706-0
PMID:40332748
Abstract

PURPOSE

The efficacy of radiofrequency catheter ablation (RFCA) alone for nonparoxysmal atrial fibrillation (NPAF) is unsatisfactory. This study investigated the effect of sacubitril/valsartan, a type of angiotensin receptor neprilysin inhibitor (ARNI), on NPAF patients with hypertension who underwent RFCA and analysed the possible influencing factors.

METHODS

In this prospective, randomized clinical trial, 240 NPAF patients were randomly divided into a control group (n = 121) and an ARNI group (n = 119). The primary outcome was freedom from atrial fibrillation (AF) and atrial tachycardia/atrial flutter (AT/AFL) for ≥ 30 s without antiarrhythmic medications at 15 months after the 3-month blanking period. The secondary outcomes included recurrence types, blood pressure, echocardiographic parameters and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

RESULTS

At 15 months, a higher maintenance rate of sinus rhythm was achieved in the ARNI group compared to the control group (79.8% vs. 69.4%, hazard ratio [HR] 0.59; 95% confidence interval [CI] 0.36-0.98; P = 0.04). Moreover, a smaller left atrial diameter (adjusted mean difference -1.9 mm [95% CI -3.2 to -0.5], P = 0.02) and lower NT-proBNP level (adjusted median difference -34 pg/ml [95% CI -62 to -6], P = 0.03) were observed in the ARNI group than in the control group at 15 months. Among the patients who recurred, a lower incidence of AF (50.0% vs. 62.2%, P = 0.01) was found in the ARNI group, but presented a significantly higher incidence of AT/AFL. In the subgroup analysis, compared with those in the control group, more patients in the ARNI group achieved success in patients with EF < 50% (93.6% vs. 61.1%, P = 0.01) or low-voltage areas (LVAs) (80.0% vs. 61.3%, P = 0.02). Multivariate Cox regression analysis revealed that ARNI was an independent protective factor against AF or AT/AFL recurrence in patients with EF < 50% or LVAs at 15 months.

CONCLUSION

ARNI is effective in NPAF patients with hypertension after RFCA, especially those with EF < 50% or LVAs, which can significantly improve their prognosis.

摘要

目的

单纯射频导管消融术(RFCA)治疗非阵发性心房颤动(NPAF)的疗效并不理想。本研究探讨了血管紧张素受体脑啡肽酶抑制剂(ARNI)沙库巴曲缬沙坦对接受RFCA的NPAF合并高血压患者的影响,并分析了可能的影响因素。

方法

在这项前瞻性随机临床试验中,240例NPAF患者被随机分为对照组(n = 121)和ARNI组(n = 119)。主要结局是在3个月空白期后的15个月内,无需使用抗心律失常药物且房颤(AF)和房性心动过速/心房扑动(AT/AFL)持续≥30秒的无事件生存率。次要结局包括复发类型、血压、超声心动图参数和N末端脑钠肽前体(NT-proBNP)水平。

结果

在15个月时,ARNI组的窦性心律维持率高于对照组(79.8%对69.4%,风险比[HR] 0.59;95%置信区间[CI] 0.36 - 0.98;P = 0.04)。此外,在15个月时,ARNI组的左心房直径较小(调整后平均差值 -1.9 mm [95% CI -3.2至 -0.5],P = 0.02),NT-proBNP水平较低(调整后中位数差值 -34 pg/ml [95% CI -62至 -6],P = 0.03)。在复发的患者中,ARNI组的AF发生率较低(50.0%对62.2%,P = 0.01),但AT/AFL的发生率显著较高。在亚组分析中,与对照组相比,ARNI组中射血分数(EF)<50%(93.6%对61.1%,P = 0.01)或存在低电压区(LVA)(80.0%对61.3%,P = 0.02)的患者成功率更高。多因素Cox回归分析显示,ARNI是15个月时EF<50%或存在LVA的患者预防AF或AT/AFL复发的独立保护因素。

结论

ARNI对RFCA术后的NPAF合并高血压患者有效,尤其是EF<50%或存在LVA的患者,可显著改善其预后。

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本文引用的文献

1
Sacubitril-Valsartan Lowers Atrial Fibrillation Recurrence and Left Atrial Volume Post-catheter Ablation: Systematic Review and Meta-Analysis.沙库巴曲缬沙坦降低导管消融术后房颤复发率及左心房容积:系统评价与荟萃分析
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Left Atrial Low-Voltage Areas Predict the Risk of Atrial Fibrillation Recurrence after Radiofrequency Ablation.左心房低电压区预测射频消融术后心房颤动复发风险
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Evaluation of the Efficacy of Sacubitril/Valsartan on Radiofrequency Ablation in Patients with Hypertension and Persistent Atrial Fibrillation.
沙库巴曲缬沙坦对高血压合并持续性心房颤动患者射频消融疗效的评估
Cardiovasc Drugs Ther. 2025 Feb;39(1):97-106. doi: 10.1007/s10557-023-07493-6. Epub 2023 Sep 7.
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Overview of Cardiac Arrhythmias and Treatment Strategies.心律失常及治疗策略概述
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Sacubitril/valsartan reduces susceptibility to atrial fibrillation by improving atrial remodeling in spontaneously hypertensive rats.沙库巴曲缬沙坦通过改善自发性高血压大鼠心房重构降低心房颤动易感性。
Eur J Pharmacol. 2023 Aug 5;952:175754. doi: 10.1016/j.ejphar.2023.175754. Epub 2023 May 12.
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Angiotensin receptor-neprilysin inhibitor therapy and recurrence of atrial fibrillation after radiofrequency catheter ablation: A propensity-matched cohort study.血管紧张素受体脑啡肽酶抑制剂治疗与射频导管消融术后房颤复发:一项倾向匹配队列研究。
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