Objective: To evaluate the clinical effects of S/V introduction in a population of pts with HFrEF followed in a tertiary hospital HF Clinic.
Methods: Prospective study of consecutive pts with HFrEF treated with S/V. Clinical, echocardiographic and laboratorial data were collected before and after the introduction of the drug. Episodes of HF decompensation (defined as the need to increase oral dose of diuretics or intravenous administration of diuretics) and hospitalizations during the follow-up period were registered.
The number of decompensation episodes or hospitalization were compared with the number of similar events that occurred in a period with exactly the same time duration but preceding the first dose of S/V. Comparative statistical analysis was performed using Wilcoxon test.
Results: One hundred and two pts were included. The median follow-up time was 6 (4-10) months. There was a significant improvement in NYHA functional class (FC), mainly due to a marked decrease in the number of pts in FC III (15.7 vs. 2%, P <0.001) (Table 1). Mean left ventricle ejection fraction (29.5±3.2 vs. 34±5.8%, P =0.005) also improved, and NTproBNP was significantly reduced (3107±2128 vs. 2619±1437pg/mL, P <0.001) after S/V prescription.
There was no significant change in serum creatinine (1.24±0.49 vs. 1.26±0.46 mg/dL, P =NS) or systolic blood pressure (120.2±18.8 vs. 119.2 ± 18.8mmHg, P =NS).
Importantly, there was a significant reduction in the number of HF decompensations (49 episodes in 37 pts vs. 10 episodes in 8 pts, P <0.001) and hospitalizations (31 episodes in 23 pts vs. 10 events in 7 pts, P <0.001) after initiation of the drug.
Conclusion: Starting sacubitril/valsartan in a population of patients followed in a HF Clinic was associated with significant clinical improvement, marginal echocardiographic improvement, and NTproBNP reduction. In parallel, the introduction of the drug led to a significant reduction of HF decompensation episodes and hospitalizations. These data derived from a real-life
population confirm the benefits of sacubitril/valsartan firstly demonstrated in the PARADIGM-HF Trial.