PARIS — Symptoms and exacerbations of persistent chronic obstructive pulmonary disease (COPD) can be significantly reduced when an outpatient ablation procedure that opens obstructed airways is added to drug therapy, results from the AIRFLOW-2 trial (NCT02058459) show.
"It's a new mechanism of treatment that will not replace drugs but really strengthens them," said Dirk-Jan Slebos, MD, PhD, from University Medical Center in Groningen, the Netherlands. "From my point of view, it's really a step-up approach at the moment."
"We should use pharmaceutical treatments, smoking cessation, vaccinations, and exercise training as first-line, but if patients are uncontrolled and there is disease progress, this is something that can be considered," he told Medscape Medical News.
The targeted lung denervation procedure improved lung function in COPD patients and cut respiratory problems, such as shortness of breath, by more than half, he reported here at the European Respiratory Society International Congress 2018.
There was also a significant reduction in infections and hospitalizations, he added.
Targeted Lung Denervation
The approach appears to maximize the benefits of the anticholinergic drugs that are often prescribed for patients with COPD, Slebos explained.
During the procedure, performed under general anesthesia, a bronchoscope is used to insert a balloon catheter, which contains a radiofrequency probe, into the airway. Nerves are selectively ablated to target the cholinergic pathway that regulates the inflammatory response and smooth muscle constriction. The esophagus is protected from electrodes with a tissue-mimicking gel during the 75-minute procedure.
Slebos and his colleagues assessed 82 patients in their 16-site multinational trial. Half the participants were men and half were women, and average age was 64 years. The 6-month follow-up was completed by 81 patients.
Half the participants underwent targeted lung denervation and the other half underwent a sham procedure. In addition, all received tiotropium, an anticholinergic bronchodilator.
Fewer patients in the denervation group than in the sham group experienced an adverse COPD-related event in the 3 to 6 months after the procedure (32% vs 70%; P = .0008).
And during the year after the procedure, patients in the denervation group experienced about half as many hospitalizations for respiratory complications as those in the sham group.
"The magnitude of the additional effect for the treatment group was highly significant," Slebos said.
Transient coughing was common after the procedure because of airway penetration.
About 12% of patients in the denervation group experienced gastrointestinal problems, such as nausea, bloating, and discomfort, but all had resolved by 6 months. The brief gastroesophageal symptoms, also seen after cardiac ablation, could be the result of high-dose energy being used near the parasympathetic nervous system, Slebos pointed out.
None of the procedure-related adverse events required treatment and there were no deaths during the study period.
A larger phase 3 trial is now in the planning stages, Slebos reported.
Many COPD patients might benefit from this "very promising" treatment, Marlies van Dijk, MD, also from University Medical Center but not involved in the study, said after the presentation.
"It seems to also have an effect on mucus secretion, and it would be really nice to have something to treat patients who have a lot of mucus," she told Medscape Medical News.
However, the benefits of targeted lung denervation need to be balanced with the inconvenience of undergoing a procedure that requires general anesthesia, she said.
"It's easier to pick up a medication from the pharmacy than to undergo a procedure," van Dijk pointed out. "You need a whole medical team to do these procedures."
Slebos reports financial relationships with Aeris Therapeutics, Asthmatx, Boston Scientific, Broncus Technologies, CSA Mecial, Free Flow Medical, PneumRx/BTG, Olympus, Portaero, PulmonX, and Nuvaira. Van Dijk has disclosed no relevant financial relationships.
European Respiratory Society (ERS) International Congress 2018: Abstract OA4929. Presented September 18, 2018.
Medscape Medical News © 2018
Cite this: For Stubborn COPD, Airway Ablation Bolsters Drug Effects - Medscape - Sep 20, 2018.