PIONEER-HF
Trial question
What is the role of sacubitril/valsartan in patients with HFrEF who were hospitalized for acute decompensated HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 881
881 patients (246 female, 635 male).
Inclusion criteria: patients with HFrEF who were hospitalized for acute decompensated HF.
Key exclusion criteria: receipt of sacubitril/valsartan within the past 30 days; serum potassium > 5.2 mEq/L at screening; hypersensitivity or contraindications to the study drugs; known hepatic impairment; eGFR < 30 mL/min/1.73 m².
Interventions
N=440 sacubitril/valsartan (target dose of 97 mg of sacubitril with 103 mg of valsartan BID).
N=441 enalapril (target dose of 10 mg BID).
Primary outcome
Time-averaged reduction in N-terminal pro-B-type natriuretic peptide concentration from baseline through weeks 4 and 8
0.53
0.75
0.8
0.6
0.4
0.2
0.0
Sacubitril/valsartan
Enalapril
Significant
decrease ▼
Significantly lower reduction in time-averaged the N-terminal pro-B-type natriuretic peptide concentration from baseline through weeks 4 and 8 (0.53 vs. 0.75; OR 0.71, 95% CI 0.63 to 0.81).
Secondary outcomes
Significantly greater reduction in high-sensitivity troponin T concentration (36.6 vs. 25.2; OR 1.17, 95% CI 1.06 to 1.29).
No significant difference in death (2.3% vs. 3.4%; HR 0.66, 95% CI 0.3 to 1.48).
Significant decrease in rehospitalization for HF (8% vs. 13.8%; HR 0.56, 95% CI 0.37 to 0.84).
Safety outcomes
No significant differences in worsening renal function, hyperkalemia, symptomatic hypotension, angioedema.
Conclusion
In patients with HFrEF who were hospitalized for acute decompensated HF, sacubitril/valsartan was superior to enalapril with respect to a time-averaged reduction in the N-terminal pro-B-type natriuretic peptide concentration from baseline through weeks 4 and 8.
Reference
Eric J Velazquez, David A Morrow, Adam D DeVore et al. Angiotensin-Neprilysin Inhibition in Acute Decompensated Heart Failure. N Engl J Med. 2019 Feb 7;380(6):539-548.
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