Eligibility for vericiguat in a real‐world heart failure population according to trial, guideline and label criteria: Data from the Swedish Heart Failure Registry

Abstract

AimWe investigated the eligibility for vericiguat in a real‐world heart failure (HF) population based on trial, guideline and label criteria.Methods and resultsFrom the Swedish HF registry, 23 573 patients with HF with reduced ejection fraction (HFrEF) enrolled between 2000 and 2018, with a HF duration ≥6 months, were considered. Eligibility for vericiguat was calculated based on criteria from (i) the Vericiguat Global Study in Subjects with Heart Failure and Reduced Ejection Fraction (VICTORIA) trial; (ii) European and American guidelines on HF; (iii) product labelling according to the Food and Drug Administration and European Medicines Agency. Estimated eligibility for vericiguat in the trial, guidelines, and label scenarios was 21.4%, 47.4%, and 47.4%, respectively. Prior HF hospitalization within 6 months was the criterion limiting eligibility the most in all scenarios (met by 49.1% of the population). In the trial scenario, other criteria meaningfully limiting eligibility were elevated N‐terminal pro‐B‐type natriuretic peptide levels and nitrate use. In all scenarios, eligibility was higher among patients hospitalized for HF at baseline (44.3% vs. 21.4% [trial scenario] and 97.3% vs. 47.4% [guideline/label scenarios] for hospitalized vs. non‐hospitalized patients). Overall, eligible patients were older, had more severe HF, more comorbidities, and consequently higher cardiovascular mortality and HF hospitalization rates compared with ineligible patients across all scenarios.ConclusionIn a large and contemporary real‐world HFrEF cohort, we estimated that 21.4% of patients would be eligible for vericiguat according to the VICTORIA trial selection criteria, 47.4% based on guidelines and labelling. Eligibility for vericiguat translated into the selection of a population at high risk of morbidity/mortality.

Vericiguat: The Fifth Harmony of Heart Failure with Reduced Ejection Fraction

“…In addition, the label criteria were met more often than VICTORIA criteria. Nguyen et al [ 75 ] reported similar results upon analyzing HFrEF patients from SwedeHF, suggesting that the design of VICTORIA successfully recruited high-risk patients at the cost of limiting real-world eligibility. Nevertheless, all currently approved HF medications have been tested in both low- and high-risk patients [ 76 ].…”

“…Indeed, the VICTORIA placebo group had better outcomes compared to PINNACLE patients. Two different studies have evaluated whether enrolled patients fulfilled not only VICTORIA’s inclusion criteria but also the FDA label criteria [ 74 , 75 ]. In the Korean Acute Heart Failure (KorAHF) registry [ 74 ], lower systolic blood pressure and NT-proBNP levels were the leading reasons for not fulfilling the inclusion criteria of the VICTORIA trial.…”

Guideline‐directed medical therapy in severe heart failure with reduced ejection fraction: An analysis from the HELP‐HF registry

“…Similarly, the effects of vericiguat, that recently demonstrated to improve prognosis in a high-risk HFrEF population, should be further investigated in patients with advanced HF. 41,42 Importantly, no reasons for lack of administration of GDMT were found in a large proportion of patients (ranging from 37% for ACEi/ARB/ARNI to 56% for MRA) and, similarly, no reasons for lack of titration were found in about a half of the cases. Patient-related reasons for not prescribing certain medications including frailty, cognitive impairment, dementia and lack of social and/or familial support as well as unavailability/reimbursement issues could have influenced the decision to not prescribe or uptitrate GDMT, consistently with what generally considered as clinical inertia.…”

August 2023 at a glance: Focus on epidemiology and medical therapy

“…HFH in the prior 6 months was the main limiting factor for eligibility. 43 EVO-HF was a multicentre prospective randomized trial comparing the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab (420 mg/month administered subcutaneously) plus guideline-directed medical therapy (GDMT; n = 17) versus GDMT alone (n = 22) for 1 year in patients with stable coronary artery disease and LVEF <40%, New York Heart Association class II, NT-proBNP ≥400 pg/ml, hs-TnT >10 pg/ml and low-density lipoprotein cholesterol ≥70 mg/dl. No significant changes in hs-TnT levels (primary endpoint) were observed in any group at 1 year.…”

“…Only 21.4% of patients would be eligible to receive vericiguat according to VICTORIA trial selection criteria, while 47.4% of patients according to guidelines and labelling. HFH in the prior 6 months was the main limiting factor for eligibility 43 …”