September 18, 2022
2 minutes read
Source/Disclosures
Published by:
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; 16-19 Sept 2022; Boston (hybrid meeting).
Disclosure:
Pulnovo provided all pulmonary artery denervation catheters during the study. Chen claims to be the inventor of pulmonary artery denervation but not the owner of the patent on pulmonary artery denervation; Received 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 measurements of cardiac function compared to a sham procedure in patients with WHO Group 1 pulmonary arterial hypertension, the spokesperson reported.
The results of the PADN-CFDA study were presented at TCT 2022 and published simultaneously in JACC: Cardiovascular Interventions.
“As of 2012, our team and other teams have provided some data to support the treatment effect of [pulmonary artery denervation] for the treatment of group 1 pulmonary arterial hypertension, a progressive, incurable disease, but the treatment effect of PADN for group 1 was not studied in a randomized manner.” Shao Liang Chen, MDFellow at the Collaborative Innovation Center for Cardiovascular Disease Translational Medicine at Nanjing Medical University in Nanjing, China 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 study enrollment, patients were allowed to be off medications specific for pulmonary arterial hypertension for 30 days prior to enrollment.
That Mayo Clinic Procedures characterizes Group 1 pulmonary arterial hypertension as loss and obstructive remodeling of the pulmonary vascular bed and with precapillary pulmonary hypertension defined as mean pulmonary artery pressure of 20 mm Hg or greater, pulmonary artery wedge pressure of 15 mm Hg or less, and pulmonary vascular resistance of 3 wood units or greater.
Participants were assigned to either pulmonary artery denervation or a sham procedure; All were taking a phosphodiesterase-5 inhibitor.
The primary endpoint was the change in 6-minute walk distance between groups from baseline to 6 months.
The investigators reported that patients treated with pulmonary artery denervation experienced a greater improvement in 6-minute walk distance compared to the sham group from baseline to 6 months, with a mean adjusted difference between groups of 33, 8 m (95% CI, 16.7-50.9; P < 0.001).
Chen and colleagues also observed a mean reduction in pulmonary vascular resistance of 3 Wood units after denervation compared to a mean reduction of 1.9 Wood units after sham therapy (adjusted difference -1.4; 95% CI, -2.6 to -0.2).
Compared to the sham group, the denervation group also had improvements in right ventricular function, reduced tricuspid regurgitation, and reductions in pro-B-type N-terminal natriuretic peptide, according to the study.
In addition, clinical worsening of pulmonary arterial hypertension during 6 months of follow-up was less in the denervation group than in the sham treatment group (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 in improved exercise capacity at 6 months compared to sham therapy,” Chen said during the press conference. “In addition, treatment with the PADN was reduced [pulmonary vascular resistance] and [pulmonary artery pressure]improved cardiac function, reduced tricuspid regurgitation and NT-proBNP levels, and improved clinical outcomes during 6 months of follow-up.”
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Roxana Mehran, MD
This is only an early study that requires further evaluation. I find it fascinating, but I’m not sure it’s a pivotal study for us to think about right now. It certainly needs to be reiterated in a global sense before we can say that this is the answer, but it’s certainly exciting to see something for these patients as they are some of the most difficult patients to treat and often have poor outcomes.
We now have drugs that are showing good results in these patients as well. We have to take all of that into account. This study is just an interesting observation, and we need more.
Roxana Mehran, MD
Professor of Medicine
Director, Interventional Cardiovascular Research and Clinical Trials
Zena and Michael A. Weiner Cardiovascular Institute
Icahn School of Medicine at Mount Sinai
Disclosure: Mehran reports receiving institutional research payments or institutional consulting fees from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Janssen, Magenta, Medtronic, Novartis, OrbusNeich, Philips, RenalPro, Vivasure and Customs; personal fees from CineMed Research and WebMD; and holds less than 1% interest in Applied Therapeutics, Elixir Medical and Stel Controlrad (spouse).
