Real-world eligibility for vericiguat according to trial, guideline, and labelling eligibility criteria: data from the Swedish Heart Failure Registry

Abstract Introduction The VICTORIA trial demonstrated the efficacy and safety of vericiguat in patients with worsening heart failure (HF) an ejection fraction (EF) <45%. Trial selection criteria might limit external validity, perceived low generalisability may be underlying reason for poor implementation new treatments. Purpose We calculated proportions who would eligible according to trial, guideline, labelling scenarios a large unselected real-word HF population, compared ineligible populations patient characteristics outcomes. Methods From Swedish Registry (SwedeHF), 41,635 EF<40% recorded between May 2000 December 2018 were considered. applied trial's criteria, 2021 European Society Cardiology (ESC) guidelines' recommendation, regulatory Food Drug Administration Medicines Agency. Outcome rates (cardiovascular [CV] non-CV death, first hospitalisation [HFH]) using exact Poisson test significance level 5%. also analysed 60,351 EF<50% scenario. Results Eligibility based on 21.2%, 25.7%, 44.5%, respectively (Figure 1). major impacts eligibility were: 1) scenario - inclusion criteria: recent HFH (within 6 months) elevated NT-proBNP (met by 47.5% 74.4% respectively), exclusion nitrate use (14.0%); 2) guideline scenario: duration longer than months (as proxy optimal medical therapy) (47.5% 57.6%, respectively); 3) (47.5%). In EF<50%, was slightly lower, impact overall similar those EF<40%. Overall, older, less likely female, had more severe comorbidities, greater mortality morbidity Conclusion contemporary real-world cohort EF<40%, limited, i.e. ∼20–25%, whereas it higher scenario, ∼45%. successfully selected population enriched CV events but risk events, which is consistent comorbidities vs. patients, requirement rendered many ineligible. Our findings provide insights designing inclusive feasible future trials help stakeholders assess consequences eligibility. Funding Acknowledgement Type funding sources: Private grant(s) and/or Sponsorship. Main source(s): Bayer AG