Cardiovascular Center, MacKay Memorial Hospital, No. 9, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City, 104 Taiwan.
Department of Medicine, Mackay Medical College, No. 46, Section 3, Zhongzheng Road, Sanzhi District, New Taipei City, 252 Taiwan.
Eur Heart J Cardiovasc Pharmacother. 2022 Feb 16;8(2):118-129. doi: 10.1093/ehjcvp/pvaa125.
Although the beneficial effect of sacubitril/valsartan (SAC/VAL) compared to enalapril was consistent across ischaemic cardiomyopathy (ICM) and non-ischaemic cardiomyopathy (NICM) groups, the PARADIGM-HF study did not analyse the effect of ventricular remodelling on patients with different aetiologies, which may affect clinical treatment outcomes. This study aimed to compare left ventricular ejection fraction (LVEF) following SAC/VAL treatment and its association with clinical outcomes.
A total of 1576 patients were analysed. Patients were grouped by LVEF changes following SAC/VAL treatment for 8-month period. LVEF improvement ≥15% was defined as 'significant improvement', and <5% or worse was classified as 'lack of improvement'. The primary outcome was a composite of cardiovascular death and unplanned hospitalization for heart failure. Patients with NICM had lower baseline LVEF but improvement was significantly greater comparing to those with ICM (baseline 28.0 ± 7.7% vs. 30.1 ± 7.1%, P < 0.001, LVEF increase of 11.1 ± 12.6% vs. 6.7 ± 10.2%, P < 0.001). The effect of functional improvement of SAC/VAL on NICM patients showed bimodal distribution. Primary endpoints were inversely associated with LVEF changes in NICM patients: adjusted hazard ratio was 0.42 [95% confidence interval (CI) 0.31-0.58, P < 0.001] for NICM patients with significant improvement, and was 1.73 (95% CI 1.38-2.16, P < 0.001) for NICM patients but lack of improvement. Primary endpoints of ICM patients did not demonstrate an association with LVEF changes.
Patients with NICM had higher degree of LVEF improvement than those with ICM following SAC/VAL treatment, and significant improvement of LVEF in NICM patients indicates favourable outcome.
尽管沙库巴曲缬沙坦(SAC/VAL)与依那普利相比在缺血性心肌病(ICM)和非缺血性心肌病(NICM)患者中均具有有益效果,但 PARADIGM-HF 研究并未分析心室重构对不同病因患者的影响,而这可能会影响临床治疗结局。本研究旨在比较 SAC/VAL 治疗后左心室射血分数(LVEF)的变化及其与临床结局的关系。
共分析了 1576 例患者。根据 SAC/VAL 治疗 8 个月后 LVEF 的变化将患者分组。LVEF 改善≥15%定义为“显著改善”,<5%或更差定义为“缺乏改善”。主要结局为心血管死亡和心力衰竭非计划性住院的复合终点。NICM 患者的基线 LVEF 较低,但与 ICM 患者相比,改善程度显著更大(基线时 28.0±7.7%比 30.1±7.1%,P<0.001,LVEF 增加 11.1±12.6%比 6.7±10.2%,P<0.001)。SAC/VAL 改善的功能效果对 NICM 患者的影响呈双峰分布。主要终点与 NICM 患者的 LVEF 变化呈负相关:NICM 患者中,LVEF 显著改善的调整后危险比为 0.42(95%置信区间[CI] 0.31-0.58,P<0.001),而 LVEF 缺乏改善的调整后危险比为 1.73(95% CI 1.38-2.16,P<0.001)。ICM 患者的主要终点与 LVEF 变化无相关性。
与 ICM 患者相比,NICM 患者在接受 SAC/VAL 治疗后 LVEF 改善程度更高,且 NICM 患者的 LVEF 显著改善提示预后良好。