Pulnovo Medical has announced positive 1-year results from the Pulmonary Artery Denervation (PADN)-China Food and Drug Administration (CFDA) pivotal study with patients with pulmonary arterial hypertension (PAH). Results were published in JACC: Cardiovascular Interventions.
PADN is a novel catheter-based procedure that has successfully been used to improve exercise tolerance and hemodynamic parameters. Its clinical benefits were validated in the PADN-CFDA study, which revealed significant improvements in patients’ exercise capacity, hemodynamic parameters, and clinical outcomes within 6 months of the procedure.
The multicenter, randomized, blinded, sham-controlled study was developed to evaluate the safety profile of PADN for treating patients with PAH. This study enrolled 128 clinically stable patients with PAH aged between 18 and 70 years. Among those enrolled, 63 patients were placed in the PADN group (PADN + phosphodiesterase type 5 inhibitor [PDE-5i]). There were 65 patients enrolled in the sham group (sham procedure + PDE-5i).
From baseline until 1 year after the intervention, patients in the PADN group demonstrated significant improvements in their 6-minute walk distance, outperforming the sham group.
Read more about PAH etiology
The research team also reported that patients in the sham group experienced greater clinical worsening than patients in the PADN group. This was validated by a number of set parameters, such as PAH-related hospitalizations, World Health Organization (WHO) functional class IV or an increase of 1 or more grades, and the need for additional therapies.
In addition, patients in the PADN + PDE-5i group experienced improved right ventricular function and reduced tricuspid regurgitation. They also experienced improved pulmonary vascular resistance, pulmonary arterial pressure, and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels.
“Further analyzing the results of the PADN-CFDA study from a risk stratification perspective, Professor Chen [Shaoliang of Nanjing Medical University] noted that, in patients with PAH, PADN plus PDE-5i significantly improved exercise capacity, NT-proBNP, hemodynamics, and clinical outcomes during the 6-month follow-up among intermediate-high risk patients,” Pulnovo reported in a news release.
Pulnovo Medical reports positive one-year results for PADN-CFDA trial in pulmonary arterial hypertension (PAH) treatment. News release. Pulnovo Medical; February 27, 2023.