Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial
Gaëtan Deslée, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Luc Thiberville, Sylvie Leroy, Armelle Marceau, Sophie Laroumagne, Jean Pierre Mallet, Sylvain Dukic, Coralie Barbe, Julie Bulsei, Damien Jolly, Isabelle Durand-Zaleski, Charles Hugo Marquette, REVOLENS Study Group, Hervé Vallerand, Sandra Dury, Jeanne Marie Perotin, François Lebargy, Johanna Pradelli, Matthieu Buscot, Pierre Wolter, Michel Poudenx, Marie Christine Dombret, Frédérique Servin, Marie Pierre Debray, Cécile Chenivesse, Alain Palot, Carine Gomez, Philippe Astoul, Nathalie Lesavre, Anne Sophie Gamez, Philippe Torodo, Christophe Brousse, Clément Broissin, Yoann Thibout, Fabrice Di Palma, Frédéric Costes, Amandine Briault, François Arbib, Michele Porzio, Benjamin Renaud-Picard, Bénédicte Toublanc, Géraldine François, Antoine Cuvelier, Samy Lachkar, Margaux Verdier, Michael Maizieres, Delphine Gras, Philippe Benoit, Annick Leclainche, François Fourrier, Eric Hachulla, Nicolas Roche, Daniel Dusser, Gaëtan Deslée, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Luc Thiberville, Sylvie Leroy, Armelle Marceau, Sophie Laroumagne, Jean Pierre Mallet, Sylvain Dukic, Coralie Barbe, Julie Bulsei, Damien Jolly, Isabelle Durand-Zaleski, Charles Hugo Marquette, REVOLENS Study Group, Hervé Vallerand, Sandra Dury, Jeanne Marie Perotin, François Lebargy, Johanna Pradelli, Matthieu Buscot, Pierre Wolter, Michel Poudenx, Marie Christine Dombret, Frédérique Servin, Marie Pierre Debray, Cécile Chenivesse, Alain Palot, Carine Gomez, Philippe Astoul, Nathalie Lesavre, Anne Sophie Gamez, Philippe Torodo, Christophe Brousse, Clément Broissin, Yoann Thibout, Fabrice Di Palma, Frédéric Costes, Amandine Briault, François Arbib, Michele Porzio, Benjamin Renaud-Picard, Bénédicte Toublanc, Géraldine François, Antoine Cuvelier, Samy Lachkar, Margaux Verdier, Michael Maizieres, Delphine Gras, Philippe Benoit, Annick Leclainche, François Fourrier, Eric Hachulla, Nicolas Roche, Daniel Dusser
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 with emphysema 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 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.
Results: 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 ∞; 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, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (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 < .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) (P < .001); the incremental cost-effectiveness ratio was $782,598 per additional quality-adjusted life-year.
Conclusions and relevance: 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.
Trial registration: clinicaltrials.gov Identifier: NCT01822795.
Source: PubMed