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• W2235508765 abstract "<h3>Importance</h3> 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. <h3>Objective</h3> To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. <h3>Design, Setting, and Participants</h3> Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). <h3>Interventions</h3> 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. <h3>Main Outcomes and Measures</h3> The primary outcome was improvement of at least 54 m in 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. <h3>Results</h3> Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was 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 ∞;<i>P</i> = .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 ∞) (<i>P</i> = .001) and +0.08 L (95% CI, 0.03 L to ∞) (<i>P</i> = .002) for forced expiratory volume in the first second, +21 m (95% CI, −4 m to ∞) (<i>P</i> = .06) and +21 m (95% CI, −5 m to ∞) (<i>P</i> = .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<i>P</i> < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was $47 908 (95% CI, $47 879-$48 073) (<i>P</i> < .001); the incremental cost-effectiveness ratio was $782 598 per additional quality-adjusted life-year. <h3>Conclusions and Relevance</h3> In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications. <h3>Trial Registration</h3> clinicaltrials.gov Identifier:NCT01822795" @default.
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• W2235508765 date "2016-01-12" @default.
• W2235508765 modified "2023-10-14" @default.
• W2235508765 title "Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema" @default.
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• W2235508765 doi "https://doi.org/10.1001/jama.2015.17821" @default.
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