September 18, 2022
2 min read
Chen SL, et al. Late-Breaking Clinical Science in Vascular Disease and Hypertension: Session III, in Collaboration With The Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
Pulnovo provided all pulmonary artery denervation catheters during the study. Chen reports being the inventor of pulmonary artery denervation but not the owner of the pulmonary artery denervation patent; receiving speaker honoraria from BioMed, Boston International Scientific, Medtronic, Microport, Pulnovo and Sanofi; and receiving grants from the National Scientific Foundation of China.
BOSTON — Pulmonary artery denervation improved exercise capacity and measures of cardiac function vs. a sham procedure in patients with WHO group 1 pulmonary arterial hypertension, speaker reported.
The results of the PADN-CFDA trial were presented at TCT 2022 and simultaneously published in JACC: Cardiovascular Interventions.
“From 2012, our team and other teams have provided some data to support the treatment effect of [pulmonary artery denervation] for treatment of group 1 pulmonary arterial hypertension, which is a progressive, incurable disease, but the treatment effect of PADN for group 1 has not been studied in randomization,” Shao-Liang Chen, MD, fellow at the Collaborative Innovation Center for Cardiovascular Disease Translational Medicine at Nanjing Medical University in Nanjing, China, said during a press conference.
Chen and colleagues conducted a sham-controlled randomized trial to evaluate the effects of pulmonary artery denervation in 128 patients with group 1 pulmonary hypertension. For trial inclusion, patients were free from exposure to pulmonary arterial hypertension-specific drugs for 30 days prior to enrollment.
The Mayo Clinic Proceedings characterizes group 1 pulmonary arterial hypertension as loss and obstructive remodeling of the pulmonary vascular bed, and featuring precapillary pulmonary hypertension defined as mean pulmonary arterial pressure of 20 mm Hg or more, pulmonary artery wedge pressure of 15 mm Hg or less and pulmonary vascular resistance of 3 Wood units or more.
Participants were assigned to either pulmonary artery denervation or a sham procedure; all were taking a phosphodiesterase-5 inhibitor.
The primary endpoint was between-group change in 6-minute walk distance from baseline to 6 months.
Researchers reported patients treated with pulmonary artery denervation experienced greater improvement in 6-minute walk distance compared with the sham group from baseline to 6 months, with a mean adjusted between-group difference of 33.8 m (95% CI, 16.7-50.9; P < .001).
Chen and colleagues also observed average reductions of 3 Wood units for pulmonary vascular resistance after denervation, compared with a mean reduction of 1.9 Wood units after sham (adjusted difference, –1.4; 95% CI, –2.6 to –0.2).
Compared with the sham group, the denervation group also had improvements in right ventricular function, reduced tricuspid regurgitation and decreased N-terminal pro-B-type natriuretic peptide, according to the study.
Moreover, during 6 months of follow-up, clinical worsening of pulmonary arterial hypertension was less in the denervation group compared with sham (1.6% vs. 313.8%; OR = 0.11; 95% CI, 0.01-0.87) and clinical satisfaction was greater (57.1% vs. 32.3%; OR = 2.79; 95% CI, 1.37-5.82), according to the study.
“Treatment with the PADN plus [a phosphodiesterase-5 inhibitor] is safe and resulted improved exercise capacity at 6 months compared with sham,” Chen said during the press conference. “In addition, treatment with the PADN reduced [pulmonary vascular resistance] and [pulmonary artery pressure], improved the cardiac function, reduced tricuspid regurgitation and NT-proBNP levels and improved clinical outcomes during 6-month follow-up.”