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Preliminary Communication |

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema The REVOLENS Randomized Clinical Trial

Gaëtan Deslée, MD, PhD1; Hervé Mal, MD, PhD2; Hervé Dutau, MD, PhD3; Arnaud Bourdin, MD, PhD4; Jean Michel Vergnon, MD, PhD5; Christophe Pison, MD, PhD6; Romain Kessler, MD, PhD7; Vincent Jounieaux, MD, PhD8; Luc Thiberville, MD, PhD9; Sylvie Leroy, MD10; Armelle Marceau, MD2; Sophie Laroumagne, MD3; Jean Pierre Mallet, MD4; Sylvain Dukic, PhD11; Coralie Barbe, MD12; Julie Bulsei, PharmD13; Damien Jolly, MD, PhD12; Isabelle Durand-Zaleski, MD, PhD13; Charles Hugo Marquette, MD, PhD10 ; for the REVOLENS Study Group
[+] Author Affiliations
1Service de Pneumologie, INSERM U903, Hôpital Universitaire de Reims, Reims, France
2Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France
3Service d’Oncologie Thoracique, Maladies de la Plèvre, Pneumologie Interventionnelle, Hôpital Universitaire de Marseille, Marseille, France
4Département de Pneumologie et Addictologie, PhyMedExp, Inserm U1046, CNRS UMR, Hôpital Universitaire de Montpellier, Montpellier, France
5Service de Pneumologie, Hôpital Universitaire de Saint-Étienne, Saint-Étienne, France
6Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Inserm 1055, Hôpital Universitaire de Grenoble Alpes, Grenoble, France
7Service de Pneumologie, Hôpital Universitaire de Strasbourg, Strasbourg, France
8Service de Pneumologie, Hôpital Universitaire d’Amiens, Amiens, France
9Service de Pneumologie, Hôpital Universitaire de Rouen, Rouen, France
10Service de Pneumologie, IRCAN, UMR CNRS 7284/Inserm U1081, Team 3, Hôpital Universitaire de Nice Sophia Antipolis, Nice, France
11Département de Pharmacovigilance, Hôpital Universitaire de Reims, Reims, France
12Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire de Reims, Reims, France
13URC Eco IdF, Unité de Recherche Clinique en Économie de la Santé d’Ile de France, AP-HP Paris, Paris, France
JAMA. 2016;315(2):175-184. doi:10.1001/jama.2015.17821.
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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

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Flow of Participants in the REVOLENS Study

CT indicates computed tomography; FEV1, forced expiratory volume in the first second.

aThe reasons for not performing bilateral treatment were death before second treatment (n = 1), anaphylactic shock at induction of anesthesia for the second coil treatment (n = 1) (further analyses demonstrated allergy to penicillin), and pneumonia after the first coil treatment leading to unwillingness of the patient to undergo a second coil treatment (n = 1).

bThese 2 patients were alive at 12 months but did not attend the planned visit at 12 months.

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