Pulmonary vascular disease & thromboembolism
A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial
Primary resultResult — go to the resultAdjusted hazard ratio 0.17 95% CI 0.05–0.60Authors' conclusion
In this multicentre sham-controlled randomised trial, PADN treatment for Group 1 PAH significantly reduced clinical worsening and improved the 6MWD during 1-year follow-up in patients treated with a PDE-5i.
Study context
- Population
- Patients with Group 1 pulmonary arterial hypertension1-year follow-up in all
- Participants
- 128 patients
- Comparison
- Pulmonary artery denervation (PADN) plus PDE-5i vs sham PADN plus PDE-5i
- Primary endpoint
- Clinical worsening (worsening of PAH [increase in WHO functional class, need for additional PAH treatments or PAH-related hospitalisation], atrial septostomy, listing for lung transplantation, or all-cause death)
- Follow-up
- 1 year after randomisation
Methodological detailsmulticentre, sham-controlled
- Multicentre
- Sham-controlled
Primary result
As reported in the abstract
Adjusted hazard ratio
0.17
95% CI 0.05–0.60
P = 0.006
Events by treatment group
PADN plus PDE-5ivs Sham plus PDE-5i
adjusted HR 0.17 (95% CI 0.05–0.60); P = 0.006
Further findings
| Outcome | Between-group change (m) (95% CI) | P value | |
|---|---|---|---|
| Change in 6MWD from baseline · 1 year | 81.2 (50.3–112.2) | P < 0.001 | |
| −50050100150Difference, m (linear scale) |
Clinical worsening by risk category (high, intermediate, low) · 1 year
- Results consistent across risk categories
- pinteraction=0.186
Original publication
A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial. EuroIntervention. Published 23 October 2023. doi:10. 4244/ eij-d-23-00349
Composed by AI from the published abstract and checked against it. How Briefs are made →