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Jeanne Marie Perotin,1 Sylvie Leroy,2 Charles Hugo Marquette,2 Hervé Mal,3 Hervé Dutau,4 Arnaud Bourdin,5 Jean Michel Vergnon,6 Christophe Pison,7 Coralie Barbe,8 Gaëtan Deslee1 On behalf of the REVOLENS Study Group 1Service de Pneumologie, INSERM U1250, Hôpital Universitaire, Reims, France; 2Service de Pneumologie, CHU de Nice, FHU OncoAge, Université Côte d’Azur, Nice, France; 3Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France; 4Service d’Oncologie Thoracique, Maladies de la Plèvre, Pneumologie Interventionnelle, Hôpital Universitaire, Marseille, France; 5Département de Pneumologie et Addictologie, PhyMedExp, INSERM U1046, CNRS UMR, Hôpital Universitaire, Montpellier, France; 6Service de Pneumologie, Hôpital Universitaire, Saint Etienne, France; 7Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Inserm1055, Hôpital Universitaire Grenoble Alpes, Université Grenoble Alpes, Grenoble, France; 8Département de Méthodologie, Pôle Recherche-Innovations, Hôpital Universitaire, Reims, France 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: NCT01822795), 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 |
