Candidacy and predicted efficacy of vericiguat in contemporary heart failure outpatient clinics

Abstract

Abstract Background Vericiguat is a novel drug class (soluble guanylate cyclase stimulator) approved for the treatment of symptomatic heart failure with reduced ejection fraction (HFrEF) patients who are stable after recent decompensation. Its safety and efficacy in high-risk HFrEF patients (ejection fraction <45%) with recent hospitalisation was demonstrated in the VICTORIA trial, along with advantages: lesser impact on blood pressure, sustained efficacy up to eGFR 15 mL/min/1.73m2. Subgroup analyses have shown variability in heart failure hospitalisation (HFH) and cardiovascular death (CVD) reduction according to NT-proBNP levels. While real-world candidacy for Vericiguat have been described in hospitalised patients, data on Vericiguat eligibility within contemporary heart failure outpatient (HF OPD) clinics is limited. Purpose We describe the proportion of HFrEF patients reviewed in HF OPD clinics eligible for vericiguat (according to the VICTORIA trial criteria) and likely to benefit from therapy based on NT-proBNP levels. Methods A retrospective review was performed on HFrEF patients reviewed in HF OPD services in 2022. Hospital records were assessed to identify community managed HFrEF patients experiencing HFH in 2022 and the VICTORIA trial's selection criteria was applied to determine Vericiguat eligibility. Predicted efficacy (reduction in HFH and/or CVD) in Vericiguat eligible patients was based on NT-proBNP level cut-off: >8000 ng/L: no benefit; ≤8000 ng/L: net benefit; ≤5314 ng/L: strong benefit. Stable NT-proBNP value was taken as the peak value within 30 days of discharge of the HFH event. Results 333 HFrEF patients were reviewed in HF OPD services in 2022. 94 (28.2%) patients experienced HFH in 2022, of which 33 (9.9%) occurred after guideline directed medical therapy (GDMT) was optimized in HF OPD review. Pharmacotherapy patterns of patients with HFH were identified at HF OPD review: 24 (33.8%) quadruple GDMT, 18 (25.4%) triple GDMT, 21 (40.8%) dual or single GDMT. 71 (21.3%) patients with HFH met the VICTORIA trial criteria and were eligible for Vericiguat. When subdivided according to NT-proBNP level cut-off, the following predicted efficacy were identified: 52 (15.6%) net benefit, 42 (12.6%) strong benefit, and 19 (5.7%) no benefit. Conclusions In HF OPD services, 28.2% of HFrEF patients may experience HFH within 1 year with 9.9% occurring despite GDMT optimization. 40.8% of community managed HFrEF patients were still only on dual or single GDMT. The proportion of community managed HFrEF patients eligible for Vericiguat is 21.3%. Based on NT-proBNP levels, the proportion likely to experience net and strong beneficial effects from Vericiguat were 15.6% and 12.6% respectively. Considering Vericiguat has advantages over the traditional barriers (hypotension, renal function) of conventional HFrEF pharmacotherapy agents, our findings provide insight into the potential real-world use of Vericiguat within contemporary HF OPD clinics.Figure 1Table 1