Heart failure & cardiomyopathies
Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials
Primary result · All-cause hospitalizationResult — go to the resultHazard ratio 0.92 95% CI 0.88–0.97Authors' conclusion
In this post hoc pooled analysis of 13 194 patients with chronic HF in the PARADIGM-HF and PARAGON-HF randomized clinical trials, sacubitril/valsartan significantly reduced hospitalization for any reason, with benefits most apparent in patients with an LVEF below normal. This reduction appeared to be principally driven by lower rates of cardiac and pulmonary hospitalizations.
Study context
- Population
- Chronic heart failure (HF), NYHA class II–IV, elevated natriuretic peptides, across the left ventricular ejection fraction (LVEF) spectrum (PARADIGM-HF LVEF ≤40%; PARAGON-HF LVEF ≥45%)
- Participants
- 13,194 participants
- Comparison
- Sacubitril/valsartan vs renin-angiotensin system inhibitor (RASi)
- Primary endpoint
- Time to first investigator-reported all-cause hospitalization
- Follow-up
- Median 2.5 (IQR 1.8-3.1) years
Methodological detailsAnalysis conducted February 5, 2024, to April 5, 2024; Cox models stratified by geographic region and trial
- Analysis conducted February 5, 2024, to April 5, 2024; Cox models stratified by geographic region and trial
Primary result
All-cause hospitalization · median 2.5 years
Hazard ratio
0.92
95% CI 0.88–0.97
P = 0.002
By group
Sacubitril/valsartan vs RASi
HR 0.92 (95% CI 0.88–0.97); P = 0.002
As reported in the abstract
- Absolute risk reduction (ARR)
- 2.1 per 100 patient-years
- NNT (patient-years of treatment to prevent 1 all-cause hospitalization (ACH))
- 48
Further findings
ACH by LVEF (subgroup)
- LVEF <60%: HR
- 0.91 (95% CI 0.86-0.96)
- LVEF ≥60%: HR
- 0.97 (95% CI 0.86-1.09)
- P for interaction = .03
Cardiac and pulmonary hospitalizations
- Lower rates with sacubitril/valsartan; seemed primarily to drive ACH reduction
Composite noncardiac hospitalizations
- Similar rates in the 2 treatment arms
Original publication
Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. Published 1 November 2024. doi:10.
Summarised from the published abstract; every number is checked against it