Incidence of cardiovascular events following vericiguat initiation in patients with heart failure with or without a recent worsening heart failure event: a hospital-based real-world cohort study

Abstract Background Vericiguat has emerged as a promising therapeutic option for heart failure (HF). However, real-world data on its clinical use remain limited. Although recent clinical trials have demonstrated its efficacy and safety in selected patient populations, there is a need to understand its usage patterns and patient trajectories in routine practice. Purpose The ROVER Japan (real-world outcomes of patients treated with vericiguat in Japanese routine care) study is designed to address the above gaps by investigating the incidence of clinical outcomes in patients initiating vericiguat. Methods This retrospective cohort study utilized secondary data from a Japanese hospital administrative database provided by Medical Data Vision Co., Ltd. Among adult patients diagnosed with HF, those who initiated a starting dose of vericiguat (2.5 mg/day) in addition to any dose of standard HF therapy between September 15, 2021, and July 31, 2024, were included. Patients were followed from the date of vericiguat initiation (index date) until death, loss to follow-up, or the end of study period (up to a maximum of one year). The cumulative incidence of cardiovascular events was assessed by Kaplan-Meier method in the overall study population and in the prespecified sub-cohorts of patients with and without a recent worsening HF (WHF) event, defined as HF hospitalisation in the previous 6 months or outpatient intravenous diuretics in the previous 3 months. Results A total of 4,936 new users of vericiguat were included. The mean age was 75.4 years, 67.4% were men, and 29.6% received quadruple HF therapy. At vericiguat initiation, 39.6% did not have a recent WHF event. Among patients with a recent WHF event, 89.6% had experienced HF hospitalisation within 3 months prior to the index date (Table). In the overall population, the one-year cumulative incidence of the composite of cardiovascular death or first HF hospitalisation was 29.8%, and those of cardiovascular death and first HF hospitalisation were 7.0% and 28.9%, respectively. Compared to patients with a recent WHF event, those without a recent WHF event had numerically lower cumulative incidences of the composite of cardiovascular death or first HF hospitalisation (16.2% versus 40.4%), cardiovascular death (3.0% versus 10.2%), and first HF hospitalisation (15.9% versus 39.0%) (Figure). Conclusion This study provides insight into the real-world outcomes of a diverse population of patients who initiated vericiguat, including those without a recent WHF event. The patients in this study were older and had a higher prevalence of comorbidities than those enrolled in the phase III VICTORIA trial. Despite these differences, the cumulative incidence for the composite outcome was largely similar to that observed in the VICTORIA trial. The findings from this study suggest the considerable impact of a recent WHF event on patient prognosis.Table.Patient characteristics Figure.Cumulative incidence