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Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe COPD (AIRFLOW): A Multicenter Randomized Controlled Trial.
Am J Respir Crit Care Med. 2019 Aug 12;:
Authors: Slebos DJ, Shah PL, Herth FJ, Pison C, Schumann C, Hübner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A, AIRFLOW-2 Trial Study Group
Abstract
RATIONALE: Targeted Lung Denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for COPD, which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucous hyper-secretion.
OBJECTIVE: To determine the safety and impact of TLD on respiratory adverse events.
METHODS: A multicenter, randomized sham-bronchoscopy controlled, double-blinded trial, with symptomatic (mMRC≥2 or CAT≥10) COPD (FEV1 30-60%pred) patients. Primary endpoint was the rate of respiratory adverse events between 3 and 6.5 months post-randomization (defined as COPD exacerbation, tachypnea, wheezing, worsening bronchitis, worsening dyspnea, influenza, pneumonia, other respiratory infections, respiratory failure, or airway effects requiring therapeutic intervention). Blinding was maintained through 12.5 months.
RESULTS: Eighty-two patients (50% female, 63.7 years ±6.8, FEV1 41.6 ±7.3%pred, mMRC 2.2 ±0.7, and CAT 18.4 ±6.1) were 1:1 randomized. During the pre-defined 3-6.5m window, patients in the TLD group experienced a significantly lower number of respiratory adverse events compared to sham (32% vs. 71%, p=0.008; odds ratio 0.19, 95%CI [0.0750, 0.4923], p=0.0006). Between 0-12.5m, these were not different (83% vs. 90%, p=0.52). The time to first COPD exacerbation requiring hospitalization in the 0 to 12.5 month window was significantly lower in the TLD group compared to sham (hazard ratio 0.35; 95%CI [0.13, 0.99] p=0.039). There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient reported symptoms, or other physiologic measures over the 12.5 months of follow up.
CONCLUSIONS: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study defined respiratory adverse events, including hospitalizations for COPD exacerbation. Clinical trial registration available at clinicaltrials.gov, ID: NCT02058459.
PMID: 31404499 [PubMed - as supplied by publisher]