Real-World Sotatercept Eligibility: Analysis from the FOCUS-PAH Registry

INTRODUCTION: Pulmonary arterial hypertension (PAH) remains burdened by suboptimal outcomes despite contemporary therapy. Sotatercept showed clinical benefit in STELLAR and ZENITH, yet trial criteria may limit real-world implementation. We quantified real-world eligibility at baseline and during follow-up and identified baseline predictors of non-eligibility. METHODS: We retrospectively analyzed 657 patients with incident PAH (2001-2024), excluding 116 with incomplete follow-up data. Inclusion criteria mirroring STELLAR were WHO functional class II/III, PVR ≥5 WU, and stable background therapy. Exclusion criteria included severe comorbidities or recent cardiovascular events. Multivariable models identified predictors of non-eligibility. Extended eligibility per ZENITH criteria was also assessed. RESULTS: Among 541 analyzed patients, 104 (19%) were ineligible at baseline, mainly due to non-permitted PAH subtypes (71%) or vasoreactivity (29%). During a median 45-month follow-up, cumulative follow-up eligibility (i.e., patients who met criteria at least once after baseline) was 50%, with most exclusions due to PVR