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JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.

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

Author information

1
Service de Pneumologie, INSERM U903, Hôpital Universitaire de Reims, Reims, France.
2
Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France.
3
Service d'Oncologie Thoracique, Maladies de la Plèvre, Pneumologie Interventionnelle, Hôpital Universitaire de Marseille, Marseille, France.
4
Département de Pneumologie et Addictologie, PhyMedExp, Inserm U1046, CNRS UMR, Hôpital Universitaire de Montpellier, Montpellier, France.
5
Service de Pneumologie, Hôpital Universitaire de Saint-Étienne, Saint-Étienne, France.
6
Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Inserm 1055, Hôpital Universitaire de Grenoble Alpes, Grenoble, France.
7
Service de Pneumologie, Hôpital Universitaire de Strasbourg, Strasbourg, France.
8
Service de Pneumologie, Hôpital Universitaire d'Amiens, Amiens, France.
9
Service de Pneumologie, Hôpital Universitaire de Rouen, Rouen, France.
10
Service de Pneumologie, IRCAN, UMR CNRS 7284/Inserm U1081, Team 3, Hôpital Universitaire de Nice Sophia Antipolis, Nice, France.
11
Département de Pharmacovigilance, Hôpital Universitaire de Reims, Reims, France.
12
Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire de Reims, Reims, France.
13
URC Eco IdF, Unité de Recherche Clinique en Économie de la Santé d'Ile de France, AP-HP Paris, Paris, France.

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.

PMID:
26757466
DOI:
10.1001/jama.2015.17821
[Indexed for MEDLINE]
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