EVALUATE-HF - EVALUATE-HF

Sep 02, 2019
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Presenter/Author:
Akshay S. Desai, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Novartis
Date Presented:
09/02/2019
Date Published:
09/02/2019
Original Posted Date:
09/02/2019
References

Contribution To Literature:

The EVALUATE-HF trial failed to show that sacubitril was effective at reducing central aortic stiffness.

Description:

The goal of the trial was to evaluate sacubitril/valsartan compared with enalapril among patients with heart failure and reduced ejection fraction (HFrEF).

Study Design

  • Randomized
  • Parallel

Patients with HFrEF were randomized to sacubitril/valsartan (97/103 mg twice daily; n = 231) versus enalapril (10 mg twice daily; n = 233) for 12 weeks.

  • Total number of enrollees: 464
  • Duration of follow-up: 12 weeks
  • Mean patient age: 68 years
  • Percentage female: 74%

Inclusion criteria:

  • HFrEF (≤40%)

Exclusion criteria:

  • Current or prior treatment with sacubitril/valsartan
  • Persistent or permanent atrial fibrillation
  • Inability to secure a technically adequate baseline hemodynamic study

Principal Findings:

The primary outcome, change in aortic impedance from baseline to 12 weeks, was -2.9 in the sacubitril/valsartan group compared with -0.7 in the enalapril group (p = 0.78).

Secondary outcomes:

  • Change in left ventricular ejection fraction: 1.9 in the sacubitril/valsartan group vs. 1.3 in the enalapril group (p = 0.24)
  • Change in mitral E/e’ ratio: -1.4 in the sacubitril/valsartan group vs. 0.3 in the enalapril group (p = 0.001)
  • Adverse events, including hypotension: 1.7% in the sacubitril/valsartan group vs. 3.9% in the enalapril group (p = 0.001)

Interpretation:

Among patients with HFrEF, sacubitril/valsartan vs. enalapril did not reduce central aortic stiffness. While global contractile function did not improve with sacubitril/valsartan, some measures of diastolic function improved. Sacubitril/valsartan was well tolerated.

References:

Desai AS, Solomon SD, Shah AM, et al. Effect of Sacubitril-Valsartan vs Enalapril on Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA 2019;Sep 2:[Epub ahead of print].

Presented by Dr. Akshay Suvas Desai at the European Society of Cardiology Congress, Paris, France, September 2, 2019.

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Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ESC 19, ESC Congress, Electric Impedance, Enalapril, Heart Failure, Hypotension, Stroke Volume, Vascular Diseases, Vascular Stiffness


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