Clinical Trial2019 Feb 11;12(3):274-284.
JOURNAL：JACC Cardiovasc Interv. Article Link
H Zhang, YL Han and SL Chen et al. Keywords: pulmonary hypertension; pulmonary artery denervation; 6-minute walk distance; heart failure
BACKGROUND - Pulmonary artery denervation (PADN) has been shown to improve hemodynamics of pulmonary arterial hypertension (PAH) in a series of patients. Additionally, benefits of targeted medical therapy for patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) secondary to left sided heart failure are unknown.
OBJECTIVES - We sought to assess the benefits of PADN among CpcPH patients in a prospective, randomized sham-controlled trial.
METHODS - 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.
RESULTS - At 6-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.
CONCLUSIONS - PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population.