Heart failure & cardiomyopathiesSecondary analysis
Sacubitril/Valsartan-Related Hypotension in Patients With Heart Failure and Preserved or Mildly Reduced Ejection Fraction
- Secondary analysis of the PARAGON-HF randomised trial
Authors' conclusion
In PARAGON-HF, a higher LVEF was associated with an increased risk of hypotension in patients treated with sacubitril/valsartan compared with valsartan.
Study context
- Population
- Patients with chronic heart failure (HF) (≥45%) with mildly reduced or preserved EF
- Participants
- 4,796 patients
- Comparison
- Sacubitril/valsartan vs valsartan
- Primary endpoint
- Hypotension (investigator-reported, SBP <100 mm Hg) after randomization
Primary result
As reported in the abstract
Hypotension
Patients with hypotension, overall
637 (13%)
Left ventricular ejection fraction (LVEF) modified the association between sacubitril/valsartan and hypotension risk; substantially higher treatment-related risk with LVEF ≥60%
Pinteraction = 0.019
Further findings
| Outcome | Estimate | P value | |
|---|---|---|---|
| CV death and total HF hospitalizations after documented hypotension · time-updated Cox models | adjusted RR 1.63 (95% CI 1.27–2.09) | P < 0.001 | |
| All-cause death after documented hypotension · time-updated Cox models | adjusted HR 1.62 (95% CI 1.28–2.05) | P < 0.001 | |
| 0.512Ratio (log scale) |
Original publication
Sacubitril/Valsartan-Related Hypotension in Patients With Heart Failure and Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. Published 25 March 2024. doi:10.1016/j.jacc.2024.02.035
Summarised from the published abstract; every number is checked against it