A series of procedural images of a pulmonary artery denervation for CpcPH from the PADN-5 trial.
The primary outcomes of pulmonary artery denervation compared to use of medical therapy alone in the PADN-5 Trial.
October 4, 2018 — Pulmonary artery denervation (PADN) is associated with significant improvements in hemodynamic and clinical outcomes in patients with capillary pulmonary hypertension (CpcPH). This was the result of the late-breaking PADN-5 trial presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) symposium.
The randomized trial PADN in patients with combined pre- and post-capillary pulmonary hypertension was presented by Shao-Liang Chen, M.D., Division of Cardiology, Nanjing First Hospital Nanjing Medical University, Nanjing, China. PADN has been shown to improve hemodynamics of pulmonary arterial hypertension (PAH) in a series of patients. Additionally, benefits of targeted medical therapy in these patients for patients secondary to left sided heart failure was unknown. The objective was to assess the benefits of PADN among CpcPH patients in a prospective, randomized sham-controlled trial.
Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mmHg, pulmonary capillary wedge pressure >15 mmHg, and pulmonary vascular resistance (PVR] > 3.0 Woods Units, were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-minute walk distance (6MWD) at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post-hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
At six-months, the mean increases in the 6MWD were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval 38.2 to 98.8; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 vs. 6.1 ± 2.9 Wood Units, p = 0.001). Clinical worsening was less frequent in the PADN group compared to the sildenafil group (16.7% vs. 40%, p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
See the slides presented at TCT 2018 for this trial.
Find links to the TCT 2018 Late-breaking Cardiovascular Clinical Trials and Videos
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