Pulmonary vascular disease & thromboembolismRandomised controlled trial
Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death
- Randomised controlled trial
- phase 3
- placebo-controlled
- add-on to background therapy
- stopped early for efficacy at prespecified interim analysis
- Stopped early for efficacy at a prespecified interim analysis
Authors' conclusion
Among high-risk adults with pulmonary arterial hypertension who were receiving the maximum tolerated dose of background therapy, treatment with sotatercept resulted in a lower risk of a composite of death from any cause, lung transplantation, or hospitalization (≥24 hours) for worsening pulmonary arterial hypertension than placebo.
Study context
- Population
- Pulmonary arterial hypertension, World Health Organization (WHO) functional class III or IV, high 1-year risk of death (REVEAL Lite 2 risk score ≥9), on maximum tolerated background therapy
- Participants
- 172 participants
- Comparison
- Add-on sotatercept vs placebo
- Sotaterceptn = 86
- Placebon = 86reference
- Primary endpoint
- Composite of:
- All-cause death
- Lung transplantation
- Hospitalization (≥24 hours) for worsening pulmonary arterial hypertension (time to first event)
Primary result
As reported in the abstract
Hazard ratio
0.24
95% CI 0.13–0.43
P < 0.001
Events by treatment group
Sotatercept vs Placebo
HR 0.24 (95% CI 0.13–0.43); P < 0.001
Further findings
All-cause death
Lung transplantation
Hospitalization for worsening pulmonary arterial hypertension
Original publication
Sotatercept in Patients with Pulmonary Arterial Hypertension at High Risk for Death. N Engl J Med. Published 31 March 2025. doi:10.1056/nejmoa2415160
Summarised from the published abstract; every number is checked against it