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The following is a summary of “Asymptomatic vs Symptomatic Hypotension With Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction in PARADIGM-HF,” published in the October 2024 issue of Cardiology by Matsumoto et al.  

Hypotension presents a significant clinical issue in patients with heart failure (HF), affecting treatment tolerance and outcomes.  

Researchers conducted a prospective study to analyze outcomes associated with asymptomatic and symptomatic hypotension in patients with HF treated with sacubitril/valsartan vs. enalapril.  

They conducted a post hoc analysis of the PARADIGM-HF (Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor [ARNI] With Angiotensin-Converting Enzyme Inhibitor [ACEI] to Determine the Impact on Global Mortality and Morbidity in HF) trial using time-updated Cox proportional hazards models to assess the efficacy and safety of sacubitril/valsartan vs. enalapril. The primary outcome examined was cardiovascular death or HF hospitalization.  

The results showed that of 8,399 patients with PARADIGM-HF, 1,343 (16.0%) experienced asymptomatic hypotension, and 936 (11.1%) experienced symptomatic hypotension post-randomization. Patients with symptomatic hypotension tended to be older and had more cardiovascular comorbidities compared to those with asymptomatic hypotension, who had lower left ventricular ejection fractions. Both types of hypotension were linked to poorer outcomes, yet sacubitril/valsartan’s efficacy on the primary outcome was preserved or enhanced in patients with hypotension: the HR for sacubitril/valsartan vs. enalapril was 0.80 (95% CI: 0.72-0.89) for no hypotension, 0.87 (95% CI: 0.70-1.08) for asymptomatic hypotension, and 0.51 (95% CI: 0.38-0.69) for symptomatic hypotension (P_interaction =0.01). Cardiovascular and all-cause death results showed a similar pattern. Sacubitril/valsartan also led to fewer treatment discontinuations in both hypotension groups compared to enalapril.  

They concluded that while hypotension was linked to worse outcomes, sacubitril/valsartan benefits were maintained or enhanced in hypotensive patients with HF.  

Source: jacc.org/doi/full/10.1016/j.jacc.2024.08.012