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

## TL;DR

This study examines the real-world outcomes of heart failure patients who started taking vericiguat, finding that treatment patterns and outcomes are similar to clinical trials.

## Contribution

The study provides real-world data on vericiguat use in a broader and more diverse heart failure population than clinical trials.

## Key findings

- Vericiguat was often initiated in patients not on quadruple foundational heart failure therapy.
- One-year cumulative incidence of cardiovascular death or heart failure hospitalization was 29.8%.
- Natriuretic peptide levels and diuretic use decreased after vericiguat initiation.

## Abstract

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.

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 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.