One-year real-world outcomes after vericiguat initiation in heart failure: The ROVER-Japan cohort study

One-year follow-up of patients with HF after initiating vericiguat. *Defined as HFH in the previous six months or outpatient intravenous diuretics in the previous three months. **Parameters were assessed at pre- (day -90 to day -1) and post-vericiguat initiation periods (day 1 to day 90, day 91 to day 180). BNP, B-type natriuretic peptide; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HF, heart failure; HFH, heart failure hospitalization; MPR, medication possession ratio; WHF, worsening heart failure. • Vericiguat was administered to a broader population compared to a clinical trial. • Vericiguat was often initiated in patients not on quadruple foundational therapy. • Multiple heart failure medications were adjusted around vericiguat initiation. • Challenges remain for persistence of heart failure therapy in real-world settings. • One-year cumulative incidence of composite outcome was similar to clinical trial. Vericiguat, a soluble guanylate cyclase stimulator, is recommended for patients with chronic heart failure (HF) who recently worsened despite guideline-directed medical therapy. However, there is limited data on its real-world utilization and outcomes. The ROVER-Japan study examined prescribing patterns and prognosis among Japanese patients who initiated vericiguat in routine practice. This retrospective cohort study analyzed secondary data from a Japanese hospital administrative database. Among adult patients diagnosed with HF, 4936 patients who initiated a starting dose of vericiguat (2.5 mg/day) on top of any fundamental HF therapy between September 15, 2021, and July 31, 2024, were included. Patients were followed for up to one year or until death, loss to follow-up, or the end of the study period. The mean age of the included patients was 75.4 (standard deviation 12.4) years. At vericiguat initiation, 60.4% of the patients had a recent worsening HF event, defined as HF hospitalization (HFH) in the previous six months or outpatient intravenous diuretics in the previous three months. Quadruple guideline-directed therapy was administered to 29.6% of patients at baseline. One year after treatment initiation, 95.7% of patients had a medication possession ratio ≥ 80%, and 66.6% continued vericiguat treatment. Natriuretic peptide levels and diuretic use decreased, while eGFR remained stable after vericiguat initiation. The one-year cumulative incidence of composite of cardiovascular death or HFH was 29.8%. This study provides real-world insights into the contemporary use and outcomes of vericiguat in a large, diverse HF population.