EVALUATE-HF研究显示，沙屈比尔-缬沙坦与依那普利对心力衰竭患者的血流动力学影响,Circulation: Heart Failure

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EVALUATE-HF研究显示，沙屈比尔-缬沙坦与依那普利对心力衰竭患者的血流动力学影响
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2021-03-05 , DOI: 10.1161/circheartfailure.120.007891
Gary F Mitchell ₁ , Scott D Solomon ₂ , Amil M Shah ₂ , Brian L Claggett ₂ , James C Fang ₃ , Joseph Izzo ₄ , Cheryl A Abbas ₅ , Akshay S Desai ₂ ,

Affiliation

背景：使用沙比特比尔-缬沙坦治疗可降低射血分数降低的心衰患者的死亡率和心力衰竭（HF）事件，并可能减少射血分数保留的心衰妇女的心衰住院率。射血分数降低至沙比特利-缬沙坦或依那普利治疗12周。尽管允许核心实验室LVEF> 0.40，但仍需在过去12个月内记录左室射血分数（LVEF）≤0.40。评估主动脉僵硬度（脉压和特征阻抗，Z _c）在基线，给药后第4周和第12周的低谷和服药后4小时进行。 3.0±0.8 mm Hg，P <0.001）和脉压（-3.0±0.8 mm Hg，P <0.001）。屈比特尔-缬沙坦组用药后的Z _c降低更大（-16±6达因×秒/ cm ⁵，P = 0.012）。事后分析发现有证据表明LVEF可以改善效应（相互作用P = 0.036）。在LVEF <0.40的情况下，沙屈比尔-缬沙坦组的服药后Z _c降低更大（低谷，-3±8达因×秒/厘米相对于给药后为⁵，-17±8达因×秒/ cm ⁵；交互作用P = 0.024），无性别差异（治疗x性交，P = 0.3）。在LVEF≥0.40的情况下，接受沙比特尔-缬沙坦治疗的女性Z _c总体下降幅度更大（女性，男性为-80±21达因×秒/ cm ⁵，男性为−20±13达因×秒/ cm ⁵；相互作用P = 0.019）。结论：在预先指定的分析中，包括在第4周和第12周进行给药前和给药后评估，使用舒必比尔-缬沙坦治疗与给药后主动脉Z _c降低更大有关。在事后分析中，沙必比尔-缬沙坦与Z _c的持续降低有关LVEF≥0.40的女性患者。唯一标识符：NCT02874794。

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Hemodynamic Effects of Sacubitril-Valsartan Versus Enalapril in Patients With Heart Failure in the EVALUATE-HF Study

Background:Treatment with sacubitril-valsartan reduces mortality and heart failure (HF) events in HF with reduced ejection fraction and may reduce HF hospitalization in women with HF with preserved ejection fraction.Methods:EVALUATE-HF randomized 464 participants (109 women) with HF with reduced ejection fraction to sacubitril-valsartan or enalapril for 12 weeks. Documented left ventricular ejection fraction (LVEF) ≤0.40 within the prior 12 months was required, although core laboratory LVEF>0.40 was permitted. Assessments of aortic stiffness (pulse pressure and characteristic impedance, Z_c) were performed at baseline and at trough and 4 hours postdose at weeks 4 and 12.Results:In models of change from baseline adjusted for baseline value, treatment with sacubitril-valsartan produced greater overall reductions in mean arterial pressure (treatment group difference, −3.0±0.8 mm Hg, P<0.001) and pulse pressure (−3.0±0.8 mm Hg, P<0.001). Postdose reductions in Z_c were greater in the sacubitril-valsartan group (−16±6 dyne×second/cm⁵, P=0.012). Post hoc analyses found evidence of effect modification by LVEF (interaction P=0.036). With LVEF<0.40, postdose reductions in Z_c were greater in the sacubitril-valsartan group (trough, −3±8 dyne×second/cm⁵ versus post-dose, −17±8 dyne×second/cm⁵; interaction P=0.024) with no sex difference (treatment×sex interaction, P=0.3). With LVEF≥0.40, treatment with sacubitril-valsartan was associated with greater overall reductions in Z_c in women (women, −80±21 dyne×second/cm⁵ versus men, −20±13 dyne×second/cm⁵; interaction P=0.019).Conclusions:In prespecified analyses that include pre- and postdose assessments at 4 and 12 weeks, treatment with sacubitril-valsartan was associated with greater postdose reductions in aortic Z_c. In a post hoc analysis, sacubitril-valsartan was associated with sustained reductions in Z_c in women with LVEF≥0.40.Registration:URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02874794.

更新日期：2021-03-16

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