Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency

Abstract

Endobronchial coil treatment (ECT) is a minimally invasive procedure developed for palliative care of patients with severe emphysema. ECT has demonstrated a decrease in hyperinflation, an improvement in quality of life, and an acceptable safety profile in randomized controlled trials (RCTs). Because alpha-1 antitrypsin deficiency (AATD) is a classical exclusion criterion in RCTs, there is no available data for ECT in AATD. In this post hoc analysis of the REVOLENS study (Réduction volumique endobronchique par spirales; ClinicalTrials.gov Identifier: NCT1822795), a multicenter 1:1 RCT which compared bilateral ECT with usual care in severe emphysema, we analyzed the efficacy and safety results at 1 year in six patients with AATD (five males, one female; mean age: 52±9 years) who underwent ECT. A significant decrease in hyperinflation (0.35 L decrease in residual volume [RV]) was observed in four out of six patients at 6 months and three out of six patients at 12 months, and an improvement in quality of life (improvement of 4 points in the St George’s Respiratory Questionnaire [SGRQ]) was observed in four out of six patients at both 6 and 12 months. Efficacy results at 6 and 12 months from the six AATD patients were compared with 84 non-AATD patients who underwent ECT, and no statistically significant differences were found for FEV₁, RV, 6MWT score and SGRQ score. Respiratory-related serious adverse event was limited to pneumonia in one AATD patient at 1 year post-ECT. This post hoc study suggests that AATD patients may have similar efficacy and safety outcomes at 1 year as non-AATD patients. Because of the paucity of available data, appropriately powered studies are needed to determine the effects of ECT in AATD.

Keywords:

• COPD
• volume reduction
• interventional
• bronchoscopy

Acknowledgments

The members of the REVOLENS Study Group include all authors and Hervé Vallerand MD, François Lebargy MD PhD, Sandra Dury MD, Claire Launois MD (Hôpital Universitaire de Reims), Johanna Pradelli MD, Matthieu Buscot MD, Celine Sanfiorenzo MD, Sylvie Korzeniewski MD, Andrea Mazzetta MD, Jennifer Griffonnet, Ariane Guillemart, Demosthenes Makris MD (Hôpital Universitaire de Nice), Armelle Marceau MD, Marie Christine Dombret MD, Frédérique Servin MD, Marie Pierre Debray MD (Hôpital Universitaire Bichat, Paris), Sophie Laroumagne MD, Fabienne Bregeon MD PhD, Carine Gomez MD, Philippe Astoul MD PhD (Hôpital Universitaire de Marseille), Nathalie Lesavre MD (Center d’Investigation Clinique 1409, AP-HM, Marseille), Jean Pierre Mallet MD, Anne Sophie Gamez MD, Philippe Tarodo MD, Christophe Brousse MD, Clément Broissin MD (Hôpital Universitaire de Montpellier), Yoann Thibout MD, Fabrice Di Palma MD, Frédéric Costes MD (Hôpital Universitaire de Saint Etienne), Amandine Briault MD, François Arbib MD, Emilie Reymond MD (Hôpital Universitaire de Grenoble), Romain Kessler MD PhD, Michele Porzio MD, Benjamin Renaud-Picard MD (Hôpital Universitaire de Strasbourg), Vincent Jounieaux MD PhD, Bénédicte Toublanc MD, Géraldine François MD (Hôpital Universitaire d’Amiens), Mathieu Salaün MD PhD, Luc Thiberville, MD PhD, Antoine Cuvelier MD PhD, Samy Lachkar MD (Hôpital Universitaire de Rouen), Margaux Bonnaire, Delphine Gras PhD (Monitoring Team, Hôpital Universitaire de Reims), Philippe Benoit MD (Pharmacie, Hôpital Universitaire de Reims), Sylvain Dukic PhD, Annick Leclainche, Damien Jolly MD PhD (Pôle Recherche-Innovations, Hôpital Universitaire de Reims). These collaborators did not receive any compensation for their contributions. The REVOLENS Study was supported by an academic grant from the French Ministry of Health (Direction Générale de l’Offre de Soins, PSTIC-2012). The coils were purchased from the manufacturer (BTG/PneumRx, 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 data, preparation, review, or approval of the manuscript, and decision to submit the manuscript for publication.

Author contributions

All authors contributed toward data analysis, drafting and critically revising the paper, gave final approval of the version to be published, and agree to be accountable for all aspects of the work. Gaëtan Deslee had full access to all of the data in the study and takes responsibility for the integrity of data and accuracy of data analysis. Study concept and design was developed by Jeanne Marie Perotin, Gaëtan Deslee, Charles Hugo Marquette, and Coralie Barbe. Data acquisition was performed by Jeanne Marie Perotin, Gaëtan Deslee, Sylvie Leroy, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, and Charles Hugo Marquette. Data analysis and interpretation were carried out by Jeanne Marie Perotin, Gaëtan Deslee, Charles Hugo Marquette, and Coralie Barbe. Manuscript was drafted by Jeanne Marie Perotin, Sylvie Leroy, Charles Hugo Marquette, and Gaëtan Deslee. Critical revision of the manuscript for important intellectual content was done by Jeanne Marie Perotin, Sylvie Leroy, Charles Hugo Marquette, Hervé Mal, Hervé Dutau, Arnaud Bourdin, Jean Michel Vergnon, Christophe Pison, Coralie Barbe, and Gaëtan Deslee. Statistical analysis was carried out by Coralie Barbe. The study was supervised by Gaëtan Deslee.

Disclosure

Gaëtan Deslee has been involved as an investigator in previous studies sponsored by BTG/PneumRx, and received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx. Hervé Mal received honorarium from Boehringer, Bayer, Roche, Astellas, Chiesi, Actellion, Pfizer, Novartis, and GlaxoSmithKline outside the submitted work. Hervé Dutau received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx. Arnaud Bourdin received honorarium from Astra Zeneca, GlaxoSmithKline, Boehringer, Novartis, Teva, Chiesi, Actellion, Gilead, and Roche outside the submitted work. Jean Michel Vergnon received travel reimbursements and speaker fees for educational sessions from BTG/PneumRx. Christophe Pison received honorarium from BTG/PneumRx and his hospital received funds to conduct trials from Holaira, PulmonX, and BTG/PneumRx. Charles Hugo Marquette has been involved as an investigator in previous studies sponsored by BTG/PneumRx, and received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx. The authors report no other conflicts of interest in this work.