Lung volume reduction coil treatment vs usual care in patients with severe emphysema the REVOLENS randomized clinical trial

Abstract

Importance Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil. Objective To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. Design, Setting, and Participants Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients withemphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). Interventions Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures. Main Outcomes and Measures The primary outcome was improvement of at least 54min the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George's Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference,±4), morbidity, mortality, total cost, and cost-effectiveness. Results Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54mwas observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18%(1-sided 95%CI, 4%to ∞ P =.03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95%CI, 0.05 L to ∞) (P =.001) and +0.08 L (95%CI, 0.03 L to ∞) (P =.002) for forced expiratory volume in the first second, +21m(95%CI,-4 m to ∞) (P =.06) and +21m(95%CI,-5mto ∞) (P =.12) for 6-minute walk distance, and-13.4 points (95%CI,-8 points to ∞) and-10.6 points (95%CI,-5.8 points to ∞) for St George's Respiratory Questionnaire (1-sided P