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Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study

Gaëtan Deslée, Sylvie Leroy, Jeanne Marie Perotin, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Mathieu Salaün, Armelle Marceau, Sandra Dury, Jonathan Benzaquen, Margaux Bonnaire, Sylvain Dukic, Coralie Barbe, Charles Hugo Marquette , on behalf of the REVOLENS Study Group13
European Respiratory Journal 2017 50: 1701740; DOI: 10.1183/13993003.01740-2017
Gaëtan Deslée
1Service de Pneumologie, INSERM U903, Hôpital Universitaire, Reims, France
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  • For correspondence: gdeslee@chu-reims.fr
Sylvie Leroy
2Service de Pneumologie, CHU de Nice, FHU OncoAge, Université Côte d'Azur, Nice, France
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Jeanne Marie Perotin
1Service de Pneumologie, INSERM U903, Hôpital Universitaire, Reims, France
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Hervé Mal
3Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France
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Hervé Dutau
4Service d'Oncologie Thoracique, Maladies de la Plèvre, Pneumologie Interventionnelle, Hôpital Universitaire, Marseille, France
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Arnaud Bourdin
5Département de Pneumologie et Addictologie, PhyMedExp, INSERM U1046, CNRS UMR, Hôpital Universitaire, Montpellier, France
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Jean Michel Vergnon
6Service de Pneumologie, Hôpital Universitaire, Saint Etienne, France
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Christophe Pison
7Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Inserm1055, Hôpital Universitaire Grenoble Alpes, Inserm1055, Université Grenoble Alpes, Grenoble, France
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Romain Kessler
8Service de Pneumologie, Hôpital Universitaire, Strasbourg, France
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Vincent Jounieaux
9Service de Pneumologie, Hôpital Universitaire, Amiens, France
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Mathieu Salaün
10Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires, Hôpital Universitaire, Rouen, France
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Armelle Marceau
3Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France
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Sandra Dury
1Service de Pneumologie, INSERM U903, Hôpital Universitaire, Reims, France
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Jonathan Benzaquen
2Service de Pneumologie, CHU de Nice, FHU OncoAge, Université Côte d'Azur, Nice, France
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Margaux Bonnaire
11Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire, Reims, France
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Sylvain Dukic
12Unité de vigilance des essais cliniques, Hôpital Universitaire, Reims, France
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Coralie Barbe
11Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire, Reims, France
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Charles Hugo Marquette
2Service de Pneumologie, CHU de Nice, FHU OncoAge, Université Côte d'Azur, Nice, France
13A list of members of the REVOLENS Study Group can be found in the acknowledgements section
13
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Abstract

In severe emphysema, endobronchial coils improve quality of life with an acceptable safety profile at 2 years http://ow.ly/eVlg30gKrPE

To the Editor:

Severe emphysema is a difficult to treat condition with limited efficacy of currently available treatments. Endobronchial coil treatment (ECT) is a minimally invasive endobronchial treatment which consists of placing shape-memory nitinol coils in emphysematous lobes to enhance lung recoil and reduce lung hyperinflation at rest and during exercise [1, 2]. Randomised studies demonstrated an improvement in exercise capacity, lung function and quality of life, and showed an acceptable safety profile at 1 year [3–6]. However, to our best knowledge, longer term safety and effectiveness results beyond 1 year have not been reported thus far.

REVOLENS (Réduction volumique endobronchique par spirales) (NCT01822795) is a 1:1 randomised controlled study of 100 patients (50 patients treated with coils and optimal medical management and 50 patients treated with optimal medical management only) in 10 centres across France. Patients treated with optimal medical management only were offered coil treatment after 1 year. The study protocol [7] and 1-year results [5] of the REVOLENS study have been previously described, demonstrating a decrease in lung hyperinflation and improvement in quality of life. In the present study, we analysed efficacy and safety data at 2 years in the 50 patients randomised to the ECT group. The ethics committee of Dijon Est I and the French Agency for Medicines and Health Products Health approved the study protocol.

Among 50 patients treated by ECT, vital status at 2 years was determined for 49 patients. Four patients died within the first year (one each from peritonitis, mesenteric ischaemia, and chronic obstructive pulmonary disease (COPD) exacerbation; one cause was undetermined) and two patients died within the second year (one from COPD exacerbation and the other from undetermined causes). One patient underwent lung transplantation within the second year. 32 patients attended the 2-year follow-up visit and 11 patients did not. Patients who died or underwent lung transplantation within 2 years (n=7) had lower body mass index (23±4 versus 19±3 kg·m−2, p=0.03) and forced expiratory volume in 1 s (FEV1) (27±7 versus 20±4%, p=0.02) and higher residual volume (RV)/total lung capacity ratio (0.69±0.06 versus 0.75±0.05, p=0.03) at baseline, respectively, than those who attended the 2-year follow-up visit (n=32). We also analysed the baseline Saint George's Respiratory Questionnaire (SGRQ) in patients who did not attend the 2-year follow-up (n=11) and found a higher score indicating worse quality of life (70±10 versus 58±12, p=0.04). Changes from baseline at 6 months, 1 year and 2 years are shown in table 1. The 6-month and 1-year results were comparable for the overall group and for the group of patients attending the 2-year follow-up visit. At 2 years, both RV and SGRQ improvements remained significant, whereas the 6-min walking test (6MWT), modified Medical Research Council dyspnoea scale, and FEV1 were not statistically different from baseline. While 45 serious adverse events (SAEs) occurred in 26 patients within the first year (0.9 SAEs per patient-year), 27 SAEs in 20 patients occurred within the second year (0.44 SAEs per patient-year). SAEs between the one and 2-year follow-up included 18 respiratory events (12 COPD exacerbation, 4 pneumonia, 1 lung transplant, 1 lung nodule). No pneumothorax, no coil migration, and no unexpected SAEs were observed between one and 2 years of follow-up.

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TABLE 1

Changes from baseline at 6 and 12 months, and 2 years after coil treatment

To our best knowledge, this is the first study to report the longer-term safety and efficacy of ECT beyond 1 year from patients randomised to the ECT group in a randomised clinical trial. A strength of this study is the low rate of loss to follow-up with 74% of evaluable patients returning for the 2-year visit. We found a clinically relevant improvement in coil-treated patients in the REVOLENS study for the SGRQ total score (mean 7.9 points and responder rate 65%) at 2 years. Despite being statistically significant, the magnitude of change in RV (mean 0.28 L and responder rate 44%) might not be clinically relevant. These results are in line with the results obtained in one monocentric study from patients treated by ECT in two early pilot studies and attending voluntary visits at 2 and 3 years [8]. However, our results must be interpreted cautiously owing to limitations in the study. As control patients in our study were offered coil treatment after 1 year, we do not have a control group at 2 years. Outcomes at 2 years after ECT for the control group are not yet available and some patients from the control group were not treated by ECT after 1 year of follow-up because of death, exclusion criteria or patient's refusal. Second, our analyses comparing the 2-year results with baseline data do not take into account the natural clinical and functional decline in severe emphysema, as shown in the control and lung volume surgery groups in the NETT study [9, 10]. We can therefore not exclude that our results at two years underestimate the effects of ECT compared to the natural history of severe emphysema. However, this is likely balanced by a selection bias presumed to occur in long-term follow-up with the best (healthiest) responders more likely to attend follow-up visits. The patients who died or underwent lung transplantation exhibited lower body mass index and FEV1, factors known to impact survival in COPD. Although our results are exploratory, they suggest that careful risk assessment is important to set appropriate expectations with patients. The patients who did not attend the 2-year follow-up visit exhibited baseline differences including a higher SGRQ score indicating worst quality of life. A potential criticism of the SGRQ results could suppose a placebo effect especially in the absence of a control group. We do agree that for patients with very severe disease refractory to medical management, enrolment in an interventional trial might engender a placebo effect; however, the highly unlikely scenario of a placebo effect maintained at 1 year becomes implausible at 2 years. Our results do show a large variability of response to treatment across a small population, as shown by large standard deviation for each variable at 2 years. Unfortunately, our sample size is too small to conduct multivariate analyses to propose predictive factors of long-term response to ECT. Nevertheless, a strength of this study is pre-specified investigation of all adverse events between one and 2 years after ECT. No unanticipated events occurred up to 2 years, and SAEs decreased after 1 year. No late pneumothorax or haemoptysis events were reported. This is an important finding, as these complications may lead to life-threatening conditions requiring intervention, such as chest tube placement, surgery or bronchial artery embolisation [11]. Long-term tolerability is crucial as the ECT is considered a permanent treatment, although we described a successful late removal of two coils, 10 months after ECT in one patient initially randomised in the usual care group in the REVOLENS study [12]. We acknowledge that adverse events occurring after 1 year in the patients who did not attend the 2-year follow-up visit may not have been reported despite our best efforts, and that underreporting of adverse events reliant on patient recall may also have occurred.

In conclusion, this 2-year prospective follow-up study showed that ECT is associated with a sustained improvement in quality of life, sustained decrease in RV and an acceptable safety profile, with no late-onset or unanticipated events occurring in the one to 2-year post-treatment period. Subsequent 5-year follow-up assessments from REVOLENS and other larger long-term clinical trials will help to better define the long-term effectiveness and safety of endobronchial treatments in severe emphysema and will help to solidify its use in the standard of care.

Disclosures

Supplementary Material

A. Bourdin ERJ-01740-2017_Bourdin

G. Deslée ERJ-01740-2017_Deslee

H. Dutau ERJ-01740-2017_Dutau

V. Jounieaux ERJ-01740-2017_Jounieaux

H. Mal ERJ-01740-2017_Mal

A. Marceau ERJ-01740-2017_Marceau

C.H. Marquette ERJ-01740-2017_Marquette

C. Pison ERJ-01740-2017_Pison

J.M. Vergnon ERJ-01740-2017_Vergnon

Acknowledgements

Author's contributions: G. Deslée had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of data analysis. Study concept and design: G. Deslée, C.H. Marquette, C. Barbe; acquisition of data: G. Deslée, S. Leroy, J.M. Perotin, H. Mal, H. Dutau, A. Bourdin, J.M. Vergnon, C. Pison, R. Kessler, V. Jounieaux, M. Salaün, A. Marceau, S. Dury, J. Benzaquen, S. Dukic, M. Bonnaire, C.H. Marquette; analysis and interpretation of data: G. Deslée, C.H. Marquette, C. Barbe; drafting of the manuscript: G. Deslée, C.H. Marquette, S. Leroy, J.M. Perotin; critical revision of the manuscript for important intellectual content: G. Deslée, S. Leroy, J.M. Perotin, H. Mal, H. Dutau, A. Bourdin, J.M. Vergnon, C. Pison, R. Kessler, V. Jounieaux, M. Salaün, A. Marceau, S. Dury, J. Benzaquen, M. Bonnaire, S. Dukic, C. Barbe, C.H. Marquette; statistical analysis: C. Barbe; study supervision: G. Deslée.

Members of the REVOLENS Study Group: The members of the REVOLENS Study Group include all authors and Hervé Vallerand, François Lebargy, Claire Launois (Hôpital Universitaire de Reims), Johanna Pradelli, Matthieu Buscot, Celine Sanfiorenzo, Sylvie Korzeniewski, Andrea Mazzetta, Jennifer Griffonnet, Ariane Guillemart, Demosthenes Makris (Hôpital Universitaire de Nice), Marie Christine Dombret, Frédérique Servin, Marie Pierre Debray (Hôpital Universitaire Bichat, Paris), Sophie Laroumagne, Fabienne Bregeon, Carine Gomez, Philippe Astoul (Hôpital Universitaire de Marseille), Nathalie Lesavre (Centre d'Investigation Clinique 1409, AP-HM, Marseille), Jean Pierre Mallet, Anne Sophie Gamez, Philippe Tarodo, Christophe Brousse, Clément Broissin (Hôpital Universitaire de Montpellier), Yoann Thibout, Fabrice Di Palma, Frédéric Costes (Hôpital Universitaire de Saint Etienne), Amandine Briault, François Arbib, Emilie Reymond (Hôpital Universitaire de Grenoble), Michele Porzio, Benjamin Renaud-Picard (Hôpital Universitaire de Strasbourg), Bénédicte Toublanc, Géraldine François (Hôpital Universitaire d'Amiens), Luc Thiberville, Antoine Cuvelier, Samy Lachkar (Hôpital Universitaire de Rouen), Delphine Gras (Monitoring team, Hôpital Universitaire de Reims), Philippe Benoit (Pharmacie, Hôpital Universitaire de Reims), Annick Leclainche, Damien Jolly (Pôle recherche et innovation, Hôpital Universitaire de Reims). Data and Safety Management Board: François Fourrier, Eric Hachulla, Nicolas Roche, Daniel Dusser. The collaborators did not receive any compensation for their contribution.

Footnotes

  • This study is registered at ClinicalTrials.gov with identifier number NCT01822795.

  • Support statement: The REVOLENS Study was supported by an academic grant from the French Ministry of Health (Direction Générale de l'Offre de Soins, PSTIC-2012) which required a randomised trial design. The coils were purchased from the manufacturer (PneumRx/BTG, Mountain View, CA, USA) which had no involvement in the study design and analysis of the data. PneumRx/BTG provided a financial support for the follow-up assessment after 1 year. The French Ministry of Health had full access to the results of the study, but had no involvement in the design and conduct of the study, collection, management, analysis, and interpretation of the data, preparation, review, or approval of the manuscript, and decision to submit the manuscript for publication. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com

  • Received July 17, 2017.
  • Accepted September 19, 2017.
  • Copyright ©ERS 2017

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Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study
Gaëtan Deslée, Sylvie Leroy, Jeanne Marie Perotin, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Mathieu Salaün, Armelle Marceau, Sandra Dury, Jonathan Benzaquen, Margaux Bonnaire, Sylvain Dukic, Coralie Barbe, Charles Hugo Marquette
European Respiratory Journal Dec 2017, 50 (6) 1701740; DOI: 10.1183/13993003.01740-2017

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Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study
Gaëtan Deslée, Sylvie Leroy, Jeanne Marie Perotin, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Romain Kessler, Vincent Jounieaux, Mathieu Salaün, Armelle Marceau, Sandra Dury, Jonathan Benzaquen, Margaux Bonnaire, Sylvain Dukic, Coralie Barbe, Charles Hugo Marquette
European Respiratory Journal Dec 2017, 50 (6) 1701740; DOI: 10.1183/13993003.01740-2017
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