Efficacy and safety of vericiguat in patients with heart failure with reduced ejection fraction and asymptomatic hypotension: insights from a multicenter observational cohort study

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Abstract
Recent VICTOR study and the VICTORY pooled analysis demonstrate that vericiguat shows significant therapeutic value in a broader population of relatively stable heart failure with reduced ejection fraction (HFrEF) patients. However, the efficacy and safety of vericiguat in HFrEF patients receiving guideline-directed medical therapy (GDMT) who present with asymptomatic hypotension (systolic blood pressure (SBP) ≤ 100 mmHg) remain unclear and require further investigation. This multicenter observational cohort study enrolled 164 patients with HFrEF and asymptomatic hypotension (SBP ≤ 100 mmHg), who voluntarily decide whether to receive vericiguat treatment. Propensity score matching (1:2) was employed to address non-random treatment allocation. The primary outcome was the first occurrence of a ≥ 30% reduction in N-terminal pro-B-type natriuretic peptide(NT-proBNP) from baseline at any assessment time point during follow-up. Kaplan-Meier (K-M) analysis and multivariable Cox regression models were applied to assess outcomes. A total of 61 vericiguat-treated patients and 36 controls completed the study. The incidence of significant NT-proBNP reduction in the vericiguat group was 68.8%, significantly higher than the 47.2% in the control group. Kaplan-Meier analysis demonstrated a significantly higher cumulative incidence of NT-proBNP reduction in the vericiguat group than in the control group (hazard ratio (HR) = 2.54, 95% confidence interval (CI): 1.42-4.55, P < 0.001). Multivariate Cox regression confirmed vericiguat as an independent predictor of significant NT-proBNP reduction (Model 3: HR = 2.34, 95% CI: 1.30-4.21, P = 0.004). In patients with HFrEF receiving GDMT with concomitant asymptomatic hypotension (SBP ≤ 100 mmHg), vericiguat treatment is significantly associated with a ≥ 30% reduction in NT-proBNP levels during follow-up. In terms of safety in this study, the small number of adverse events and the absence of major safety signals only suggest no statistically significant differences in safety between the two groups. Further large-scale studies with adequate statistical power are required to better evaluate the safety of vericiguat.

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