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December 11, 2019JAMA CardiologyOpen Access

Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure

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Why the study?

Data were limited comparing the strategies of in-hospital versus postdischarge initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure.

Does in-hospital initiation of sacubitril/valsartan improve NT-proBNP levels and clinical outcomes compared to delayed post-discharge initiation in patients with acute decompensated heart failure with reduced ejection fraction?

Population

881 patients admitted for ADHF with reduced ejection fraction and hemodynamic stability

Comparison

In-hospital initiation of sacubitril/valsartan vs in-hospital enalapril with delayed open-label switch at week 8

Design

Multicenter, randomized, double-blind, active-controlled trial with 4-week open-label extension

Follow-up

12 weeks

Key result

In-hospital initiation of sacubitril/valsartan reduced the hazard of heart failure rehospitalization or cardiovascular death compared with delayed initiation at 8 weeks (HR 0.69; 95% CI 0.49-0.97).

Authors

ADAdam D. DeVoreEBEugene BraunwaldDMDavid A. Morrow

Discussion

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Overview

Supports in-hospital over delayed sacubitril/valsartan initiation after ADHF; extends PIONEER-HF biomarker data to event reduction.

Key Points

  • To assess changes in NT-proBNP concentrations and clinical outcomes in patients switching from enalapril to sacubitril/valsartan compared with continuous early in-hospital sacubitril/valsartan initiation after acute decompensated heart failure.
  • Multicenter, randomized, double-blind, active-controlled trial (PIONEER-HF; NCT02554890) conducted at 129 US sites evaluating 881 stabilized patients admitted for acute decompensated heart failure with reduced ejection fraction.
  • Patients received 8 weeks of double-blind sacubitril/valsartan (target 97/103 mg twice daily) versus enalapril (target 10 mg twice daily), followed by a 4-week open-label phase of sacubitril/valsartan completed by 832 patients.
  • Switching from enalapril to sacubitril/valsartan between weeks 8 and 12 reduced NT-proBNP levels by -37.4% (95% CI, -28.1 to -45.6; P < .001) compared with a -17.2% reduction (95% CI, -3.2 to -29.1) in continuous sacubitril/valsartan users.
  • In-hospital initiation of sacubitril/valsartan significantly reduced the 12-week composite hazard of heart failure rehospitalization or cardiovascular death compared with delayed initiation at week 8 (HR, 0.69; 95% CI, 0.49-0.97).

Study Design

Type

RCT (n=881)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does in-hospital initiation of sacubitril/valsartan improve NT-proBNP levels and clinical outcomes compared to delayed post-discharge initiation in patients with acute decompensated heart failure with reduced ejection fraction?

P
Population
881 patients with acute decompensated heart failure with reduced ejection fraction and hemodynamic stability, mean age 61 years, followed for 12 weeks.
I
Intervention
In-hospital initiation of sacubitril/valsartan (titrated to 97/103 mg twice daily) continued for 12 weeks.
C
Comparator
In-hospital initiation of enalapril (titrated to target dose, 10 mg twice daily) for 8 weeks, followed by a switch to sacubitril/valsartan during a 4-week open-label extension phase.
O
Outcome
Changes in NT-proBNP levels from week 8 to 12.surrogate

Main Result

Hazard Ratio: 0.69 (95% CI 0.49–0.97)

In-hospital initiation of sacubitril/valsartan for acute decompensated heart failure is superior to delayed post-discharge initiation in reducing NT-proBNP levels and the composite of heart failure rehospitalization or cardiovascular death.

Cite This Study

DeVore et al. (2019) conducted an RCT in Acute decompensated heart failure with reduced ejection fraction (n=881). Sacubitril/valsartan vs. Enalapril (10 mg twice daily) for 8 weeks followed by delayed initiation of sacubitril/valsartan was evaluated on Composite of heart failure rehospitalization or cardiovascular death from randomization through week 12 (HR 0.69, 95% CI 0.49-0.97). In-hospital initiation of sacubitril/valsartan reduced the hazard of heart failure rehospitalization or cardiovascular death compared with delayed initiation at 8 weeks (HR 0.69; 95% CI 0.49-0.97).

synapsesocial.com/papers/6a7f2d80290a50e19e6f35e7https://doi.org/10.1001/jamacardio.2019.4665
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