Targeted lung denervation safely reduces respiratory events in COPD
Slebos DJ, et al. Am J Respir Crit Care Med. 2019;doi:10.1164/rccm.201903-0624OC.
Helio Pulmonology
August 19, 2019
Among patients with COPD, targeted lung denervation in addition to optimal pharmacotherapy, as compared with pharmacotherapy alone, was associated with fewer respiratory events including exacerbations, according to data from the AIRFLOW-2 study.
In this prospective, multicenter, double-blind, randomized, sham-controlled trial, 82 patients aged 40 to 75 years with moderate to severe symptomatic COPD were randomly assigned sham procedure or targeted lung denervation (Nuvaira Inc.) and followed for 12.5 months.
After a washout period, all patients were administered inhaled tiotropium 18 g per day and could continue treatment with long-acting beta agonists, short-acting muscarinic antagonists, short-acting beta agonists and inhaled corticosteroids. They were required to continue LAMA and other maintenance medications through 6 months and encouraged to continue treatment through 12 months.
The rate of respiratory events, including respiratory failure, COPD exacerbation, influenza, pneumonia, respiratory infection, worsening bronchitis, worsening dyspnea, tachypnea, wheezing or local airway effects, during 3 to 6.5 months after treatment served as the primary safety endpoint. The primary performance endpoints were device success and technical success.
Between 3 and 6.5 months after treatment, the rate of respiratory adverse events was lower in the targeted lung denervation group vs. the sham procedure group (32% vs. 71%; P = .0008). However, there was no significant difference in the rate of respiratory adverse events during the entire 12.5-month follow-up period (83% vs. 90%; P = .52).
A time-to-first-event analysis showed that targeted lung denervation, when compared with the sham procedure, was associated with a significantly lower risk for severe COPD exacerbation requiring hospitalization at 12.5 months after randomization (HR = 0.35; 95% CI, 0.13-0.99).
Additionally, during 1-year follow-up, hospitalization for COPD occurred more often in the sham procedure group vs. the intervention group (32% vs. 12%), as did readmission for COPD exacerbation among the 10 patients in each group who were hospitalized during the prior year for COPD exacerbation (70% vs. 20%; P = .0698). The researchers noted, however, that there were no statistically significant differences between groups in the risk for first moderate or severe COPD exacerbations (HR = 0.66; 95% CI, 0.38-1.16) or physiologic measures throughout the study period.
Device success was 100%, technical success was 90% and the overall number of serious adverse events, with the exception of respiratory adverse events, differed between the study groups.
The researchers noted that these findings warrant further examination in larger-scale studies to confirm the effect of targeted lung denervation on COPD exacerbation rates. – by Melissa Foster
Disclosures: This study was sponsored by Nuvaira Inc. Slebos and another author are principal investigators for the study. All other authors report no relevant financial disclosures.
Slebos DJ, et al. Am J Respir Crit Care Med. 2019;doi:10.1164/rccm.201903-0624OC.
Helio Pulmonology
August 19, 2019
Among patients with COPD, targeted lung denervation in addition to optimal pharmacotherapy, as compared with pharmacotherapy alone, was associated with fewer respiratory events including exacerbations, according to data from the AIRFLOW-2 study.
In this prospective, multicenter, double-blind, randomized, sham-controlled trial, 82 patients aged 40 to 75 years with moderate to severe symptomatic COPD were randomly assigned sham procedure or targeted lung denervation (Nuvaira Inc.) and followed for 12.5 months.
After a washout period, all patients were administered inhaled tiotropium 18 g per day and could continue treatment with long-acting beta agonists, short-acting muscarinic antagonists, short-acting beta agonists and inhaled corticosteroids. They were required to continue LAMA and other maintenance medications through 6 months and encouraged to continue treatment through 12 months.
The rate of respiratory events, including respiratory failure, COPD exacerbation, influenza, pneumonia, respiratory infection, worsening bronchitis, worsening dyspnea, tachypnea, wheezing or local airway effects, during 3 to 6.5 months after treatment served as the primary safety endpoint. The primary performance endpoints were device success and technical success.
Between 3 and 6.5 months after treatment, the rate of respiratory adverse events was lower in the targeted lung denervation group vs. the sham procedure group (32% vs. 71%; P = .0008). However, there was no significant difference in the rate of respiratory adverse events during the entire 12.5-month follow-up period (83% vs. 90%; P = .52).
A time-to-first-event analysis showed that targeted lung denervation, when compared with the sham procedure, was associated with a significantly lower risk for severe COPD exacerbation requiring hospitalization at 12.5 months after randomization (HR = 0.35; 95% CI, 0.13-0.99).
Additionally, during 1-year follow-up, hospitalization for COPD occurred more often in the sham procedure group vs. the intervention group (32% vs. 12%), as did readmission for COPD exacerbation among the 10 patients in each group who were hospitalized during the prior year for COPD exacerbation (70% vs. 20%; P = .0698). The researchers noted, however, that there were no statistically significant differences between groups in the risk for first moderate or severe COPD exacerbations (HR = 0.66; 95% CI, 0.38-1.16) or physiologic measures throughout the study period.
Device success was 100%, technical success was 90% and the overall number of serious adverse events, with the exception of respiratory adverse events, differed between the study groups.
The researchers noted that these findings warrant further examination in larger-scale studies to confirm the effect of targeted lung denervation on COPD exacerbation rates. – by Melissa Foster
Disclosures: This study was sponsored by Nuvaira Inc. Slebos and another author are principal investigators for the study. All other authors report no relevant financial disclosures.