Transportability of the comparative effect of finerenone for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction of ≥40%: insights from the FINEARTS-HF trial.

Aim: Global randomized controlled trials (RCTs) are used to inform reimbursement decisions in multiple markets, meaning the transportability of findings from these RCTs to multiple country-specific populations is critical for evidence-based decision making. This study evaluated the transportability of the FINEARTS-HF trial, which assessed finerenone in patients with heart failure (HF) and left ventricular ejection fraction ≥40%, to a real-world US population. Materials & methods: A three-phase transportability assessment was conducted. First, potential effect modifiers were identified through systematic literature review and confirmed through interaction analyses using data from FINEARTS-HF. Second, representativeness was assessed by comparing the distribution of effect modifiers in the trial and a population derived from a US electronic health record dataset. Third, direct proxy tests explored heterogeneity of treatment effects in FINEARTS-HF between US and non-US patients.

Results

Effect modifier analysis identified that treatment effects of finerenone were homogeneous across subgroups, with limited evidence of effect modification. Comparisons with the US target population indicated overall good alignment across key characteristics, with only modest imbalances, suggesting that the trial results may underestimate positive treatment effects in the US target population (i.e., effect on the primary outcome over 0.84 [0.74; 0.95]). Direct proxy tests found no statistically significant regional heterogeneity in treatment effects.

Conclusion

This study provides a structured assessment of finerenone trial transportability. Findings support the robustness of FINEARTS-HF results for US clinical practice and are not impacted by the prevalence of SGLT2-is use. The risk of transportability bias is likely to be low.