文献速递瓣膜病与结构性心脏病心力衰竭与心肌病

肾素-血管紧张素系统抑制对TAVR术后左心室质量逆转的影响:一项随机对照试验

Effect of renin-angiotensin system inhibition on left ventricular mass regression after transcatheter aortic valve replacement: a randomised controlled trial.
PubMed 文献 · Heart · 2026-05-28

该多中心、前瞻性、随机、开放标签、盲终点试验纳入200例LVEF≥40%且成功行TAVR的症状性重度主动脉瓣狭窄患者,随机分为标准治疗组或标准治疗联合RASi组。12个月时RASi组左心室质量指数下降幅度显著大于对照组(校正均差-12.77 g/m²,95%CI -24.73至-0.81;p=0.036),左室舒张末期和收缩末期容积也一致改善,但LVEF和NT-proBNP无显著差异。结论提示RASi可增强TAVR术后左室逆重构,但需更大规模试验验证临床结局获益。

要点

  • TAVR术后LVEF≥40%的心衰患者,加用RASi可显著降低12个月左心室质量指数。
  • RASi组左室舒张末期和收缩末期容积一致改善,NYHA心功能分级轻度改善。
  • LVEF和NT-proBNP未见显著差异,结构获益是否转化为临床获益尚待验证。

核心结论

  • 在TAVR术后合并心衰且LVEF≥40%的患者中,RAS抑制可增强12个月左室逆重构,表现为左室质量和容积的更大幅度逆转。
  • 这些发现支持RASi可能调节TAVR术后心肌重构,但需更大规模试验确定结构获益是否转化为临床结局改善。

研究设计与样本

  • 多中心、前瞻性、随机、开放标签、盲终点试验,纳入年龄≥60岁、症状性重度主动脉瓣狭窄、LVEF≥40%且成功行TAVR的患者。
  • 患者按1:1随机分配至单纯标准治疗组或标准治疗联合RASi组(ACE抑制剂、血管紧张素II受体拮抗剂或血管紧张素受体-脑钠肽酶抑制剂)。
  • 共随机200例,改良意向性治疗分析纳入194例(RASi组n=95;对照组n=99)。
  • 主要终点为12个月时左心室质量指数(LVMI)的变化。

主要发现

  • 12个月时,RASi治疗与对照组相比LVMI下降幅度更大(校正均差-12.77 g/m²,95%CI -24.73至-0.81;p=0.036)。
  • 左室舒张末期和收缩末期容积观察到一致的改善。
  • RASi组纽约心脏协会(NYHA)心功能分级轻度改善。
  • LVEF或NT-proBNP未见显著差异。

临床怎么用

  • 对于TAVR术后合并心衰且LVEF≥40%的患者,在标准治疗基础上考虑加用RASi可能促进左室逆重构。
  • 需关注RASi对左室质量和容积的改善作用,但不应期望LVEF或NT-proBNP的显著变化。
  • 临床决策应个体化,并等待更大规模试验明确结构获益是否转化为临床结局改善。

局限性

  • 研究样本量有限(改良意向性治疗分析194例),需更大规模试验验证。
  • 随访时间为12个月,长期结构获益和临床结局影响尚不明确。
  • 开放标签设计可能引入偏倚,尽管采用盲终点评估。

以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。

原文

BACKGROUND: Residual left ventricular (LV) hypertrophy and incomplete reverse remodelling after transcatheter aortic valve replacement (TAVR) are associated with adverse outcomes. Whether renin-angiotensin system inhibitors (RASi) promote reverse remodelling in patients with heart failure and LV ejection fraction (LVEF) ≥40% following TAVR remains uncertain. METHODS: In this multicentre, prospective, randomised, open-label, blinded-endpoint trial, patients aged ≥60 years with symptomatic severe aortic stenosis, LVEF ≥40% and successful TAVR were randomly assigned (1:1) to standard care alone or standard care plus RASi (ACE inhibitor, angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor). The primary endpoint was change in LV mass index (LVMI) at 12 months. Secondary endpoints included changes in LV volumes, LVEF, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and functional status. RESULTS: A total of 200 patients were randomised; 194 were included in the modified intention-to-treat analysis (RASi n=95; control n=99). At 12 months, RASi therapy was associated with a greater reduction in LVMI compared with control (adjusted mean difference -12.77 g/m², 95% CI -24.73 to -0.81; p=0.036). Consistent improvements were observed in LV end-diastolic and end-systolic volumes. Functional status (New York Heart Association class) improved modestly in the RASi group. No significant differences were observed in LVEF or NT-proBNP. CONCLUSION: In patients with heart failure and LVEF ≥40% following TAVR, RAS inhibition led to enhanced reverse LV remodelling over 12 months, reflected by greater regression of LV mass and volumes. These findings support the potential role for RASi in modifying post-TAVR myocardial remodelling, although larger trials are required to determine whether these structural benefits translate into improved clinical outcomes. TRIAL REGISTRATION NUMBER: ChiCTR2100042266.

来源:Heart,查看原文。版权归原作者所有。

引用

  1. Shao R, Huang FY, Liao Y, et al. Effect of renin-angiotensin system inhibition on left ventricular mass regression after transcatheter aortic valve replacement: a randomised controlled trial. Heart. 2026. PMID: 42209209. doi:10.1136/heartjnl-2025-326803

供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。