Abstract 11701: Generalizability of the Victoria Trial and the US FDA Label for Vericiguat to Patients Hospitalized for Heart Failure With Reduced Ejection Fraction in the United States

Abstract

Background: In January 2021, vericiguat was approved by US FDA to reduce the risk of cardiovascular death and HF hospitalization following a recent worsening HF event based on results of the VICTORIA trial. Limited data are available characterizing generalizability to US clinical practice. Methods: We studied patients hospitalized with HF with reduced ejection fraction (HFrEF) <45% across 525 sites in the Get With The Guidelines (GWTG)-HF registry between January 2014 - December 2020. We excluded patients who left against medical advice, transferred to an acute care facility or to hospice care, or had missing critical data elements. We applied approximate FDA label criteria (excluding eGFR<15 mL/min/1.73 m 2 , dialysis, or heart transplantation or mechanical circulatory support) and eligibility criteria of the VICTORIA trial to the GWTG-HF sample. Results: Among 241,057 patients with EF<45% in GWTG-HF, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for VICTORIA. The most frequent reason for ineligibility in the FDA label was eGFR<15 mL/min/1.73 m 2 (n=13,747; 5.7%). Sex, race, and clinical characteristics were generally similar between GWTG-HF registry participants, FDA label candidates, and VICTORIA trial eligible patients ( Table ). Among patients age ≥65 years linked to Medicare, 12-month mortality, HF hospitalization, and all-cause hospitalization were similar across the three groups. Conclusions: These data from a large US hospitalized HF registry suggest that more than 9 out of 10 patients hospitalized for HFrEF may be candidates for vericiguat based on the FDA label. Patients meeting and not meeting VICTORIA trial eligibility criteria had similar characteristics and outcomes, supporting generalizability of the FDA label and the VICTORIA trial to US practice. Medicare beneficiaries hospitalized for HFrEF and eligible for vericiguat face high post-discharge mortality and readmission rates.