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

EuroInterventionPublished Randomised controlled trial

Primary resultResult — go to the resultAdjusted hazard ratio 0.17 95% CI 0.05–0.60

Authors' 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

OutcomeBetween-group change (m) (95% CI)P value
Change in 6MWD from baseline · 1 year81.2 (50.3–112.2)P < 0.001

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 →

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