Pulmonary artery denervation is a promising treatment for pulmonary arterial hypertension: PADN-CFDA study

The findings from the study were presented on September 18 during TCT 2022 and simultaneously published in the journal JACC: Cardiovascular Interventions.

WHO defined Group I PAH as a progressive, debilitating condition. Previous observational studies have shown that pulmonary artery denervation decreases pulmonary arterial pressures in PAH. However, the effectiveness and safety of PADN have not been established yet in a randomized trial. Considering this, Hang Zhang, Division of Cardiology, Nanjing First Hospital of Nanjing Medical University, and colleagues performed the study to determine the treatment effects of PADN in Group I PAH patients.

For this purpose, the researchers enrolled WHO Group I PAH patients who were not taking PAH-specific drugs for at least 30 days in a multicenter, sham-controlled single-blind, randomized trial. Patients were given PADN plus a phosphodiesterase-5 inhibitor (PDE-5i) or a sham procedure plus a PDE-5i. The primary endpoint was the difference between groups in the change in 6-minute walk distance (6MWD) from baseline to 6 months.

The study led to the following findings:

• Among 128 randomized patients, those treated with PADN had a more significant improvement in 6MWD from baseline to 6 months (mean adjusted between-group difference 33.8 m) than a sham.
• From baseline to 6 months, PVR was reduced by -3.0 ± 0.3 Wood units after PADN and -1.9 ± 0.3 Wood units after sham (adjusted difference -1.4).
• PADN improved right ventricular function, reduced tricuspid regurgitation, and decreased NT-proBNP.
• Clinical worsening was less (1.6% vs. 313.8%; OR 0.11), and a satisfactory clinical response was more significant (57.1% vs. 32.3%; OR 2.79) with PADN treatment during 6-month follow-up.

Treating stable PAH patients with a combination of pulmonary artery denervation and phosphodiesterase-5 inhibitor was safe and also improved exercise capacity at six months versus patients getting PDE-5i treatment alone.

While the findings are promising, the researchers suggest that "results need to be replicated in larger studies (particularly in patients with a suboptimal response to combination pharmacotherapy) before applying this novel approach."

Reference:

Zhang H, Wei Y, Zhang C, et al. Pulmonary artery denervation for pulmonary arterial hypertension: a sham-controlled randomized trial. J Am Coll Cardiol Cardiovasc Intv. 2022;Epub ahead of print.

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