Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance
Background Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research question To assess the efficacy on bleeding control and the safety of first-...
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2021-01-01
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| author | Benjamin Planquette Vincent Labbe Tabassome Simon Alexandra Rousseau Jacques Cadranel Antoine Khalil Emmanuel Bergot Gérard Zalcman Guy Meyer Philippe Cluzel Vincent Jounieaux Alexandre Demoule Muriel Fartoukh Aude Gibelin Olivier Sanchez THOMAS SIMILOWSKI Claire Andrejak Valérie Chabbert Michel Djibré Sophie Tuffet Cendrine Godet Sandrine Pontier-Marchandise Julien Mayaux Marc Sapoval Vincent Le Pennec Marie-France Carette Clarisse Blayau Guillaume Voiriot Alexandre Duguet Hélène Prodanovik Guillaume Briend Anne Roche Costantino Del Giudice Olivier Pellerin Marie-Pierre Revel Patrick Courtheoux Jean Claude Meurice Elise Antone Alexandre Remond |
| author_facet | Benjamin Planquette Vincent Labbe Tabassome Simon Alexandra Rousseau Jacques Cadranel Antoine Khalil Emmanuel Bergot Gérard Zalcman Guy Meyer Philippe Cluzel Vincent Jounieaux Alexandre Demoule Muriel Fartoukh Aude Gibelin Olivier Sanchez THOMAS SIMILOWSKI Claire Andrejak Valérie Chabbert Michel Djibré Sophie Tuffet Cendrine Godet Sandrine Pontier-Marchandise Julien Mayaux Marc Sapoval Vincent Le Pennec Marie-France Carette Clarisse Blayau Guillaume Voiriot Alexandre Duguet Hélène Prodanovik Guillaume Briend Anne Roche Costantino Del Giudice Olivier Pellerin Marie-Pierre Revel Patrick Courtheoux Jean Claude Meurice Elise Antone Alexandre Remond |
| author_sort | Benjamin Planquette |
| collection | DOAJ |
| description | Background Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research question To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methods This multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset <72 hours, 100–200 mL estimated bleeding amount), related to a systemic arterial mechanism. Patients were randomly assigned (1:1) to BAE associated with medical therapy or to medical therapy alone.Results Bleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference −33%; 95% CI −13.8% to −52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.Conclusion In non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.Trial registration number NCT01278199 |
| format | Article |
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| institution | OA Journals |
| issn | 2052-4439 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open Respiratory Research |
| spelling | doaj-art-b3e54b3f8d354aa2998f0c7dcba89f9c2025-08-20T02:22:28ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392021-01-018110.1136/bmjresp-2021-000949Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundanceBenjamin Planquette0Vincent Labbe1Tabassome Simon2Alexandra Rousseau3Jacques Cadranel4Antoine Khalil5Emmanuel Bergot6Gérard ZalcmanGuy Meyer7Philippe Cluzel8Vincent JounieauxAlexandre Demoule9Muriel Fartoukh10Aude GibelinOlivier Sanchez11THOMAS SIMILOWSKI12Claire Andrejak13Valérie ChabbertMichel Djibré14Sophie Tuffet15Cendrine Godet16Sandrine Pontier-Marchandise17Julien Mayaux18Marc Sapoval19Vincent Le Pennec20Marie-France Carette21Clarisse BlayauGuillaume Voiriot22Alexandre DuguetHélène ProdanovikGuillaume BriendAnne RocheCostantino Del GiudiceOlivier PellerinMarie-Pierre RevelPatrick CourtheouxJean Claude MeuriceElise AntoneAlexandre RemondInnovative Therapies in Haemostasis, INSERM UMR S 1140, Biosurgical research lab (Carpentier Foundation), Université de Paris, Paris, FranceUniversité Paris Est, Groupe de Recherche Clinique GR05 CARMAS, Institut Mondor de recherche biomédicale, INSERM, Créteil, FranceClinical Research Platform of East of Paris, Sorbonne-Université (UPMC- Paris 06), Paris, FranceUniversity Hospital Saint Antoine, Paris, France10 Service de Pneumologie et Oncologie Thoracique, Centre Constitutif Maladies Pulmonaires Rares, Hôpital Tenon, APHP, Sorbonne Université, Paris, FranceGroupe Hospitalier Universitaire APHP-Sorbonne Université, Hôpital Tenon, Service de Radiologie, Sorbonne Université, Paris, France9 Centre de Compétence pour les Maladies Pulmonaires Rares de l`Adulte, Service de Pneumologie et Oncologie Thoracique, Hôpital Côte de Nacre, CHU de Caen, Caen, FranceUniversité Paris Descartes, Paris, FranceGroupe Hospitalier Universitaire APHP-Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Radiologie, Sorbonne Université, Paris, FranceService de Pneumologie et Réanimation Médicale du Département R3S, AP-HP, INSERM, UMRS1158 neurophysiologie respiratoire expérimentale et clinique, Sorbonne Université, Assistance Publique - Hopitaux de Paris, Paris, FranceService de Médecine Intensive Réanimation, Hôpital Tenon, Département Médico-Universitaire APPROCHES, Assistance Publique-Hôpitaux de Paris (APHP), Sorbonne Université, Paris, FranceService de Pneumologie et Soins Intensifs, HEGP, AP-HP, Innovations Thérapeutiques en Hémostase, INSERM UMRS 1140, Université de Paris, Paris, Franceservice de pneumologie département R3S, Hopital Pitie-Salpetriere, Paris, Île-de-France, FranceService de Pneumologie, CHU Amiens-Picardie, UR 4294 AGIR, université Picardie Jules-Verne, 80054 Amiens, France, Amiens, France8 Médecine Intensive Réanimation, APHP, Hôpital Tenon, Paris, FranceAssistance Publique-Hôpitaux de Paris (AP-HP), Clinical Research Platform of East of Paris (URC-CRC-CRB), Hôpital Saint Antoine, Paris, FranceCHU Poitiers, Poitiers, FranceService de Pneumologie, Centre Hospitalier Universitaire de Toulouse, Toulouse, FranceGroupe Hospitalier Universitaire APHP-Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), APHP, Paris, FranceinvestigatorService de radiologie diagnostique et thérapeutique - CHU Avenue de la Cote de Nacre – CS 30001 14033 Caen cedex 9, France, Caen, FranceService de Radiologie, Assistance Publique-Hôpitaux de Paris, Hôpital Tenon, Paris, FranceMedical Intensive Care Unit, Assistance Publique—Hopitaux de Paris, Tenon Hospital, Paris, FranceBackground Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research question To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methods This multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset <72 hours, 100–200 mL estimated bleeding amount), related to a systemic arterial mechanism. Patients were randomly assigned (1:1) to BAE associated with medical therapy or to medical therapy alone.Results Bleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference −33%; 95% CI −13.8% to −52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.Conclusion In non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.Trial registration number NCT01278199https://bmjopenrespres.bmj.com/content/8/1/e000949.full |
| spellingShingle | Benjamin Planquette Vincent Labbe Tabassome Simon Alexandra Rousseau Jacques Cadranel Antoine Khalil Emmanuel Bergot Gérard Zalcman Guy Meyer Philippe Cluzel Vincent Jounieaux Alexandre Demoule Muriel Fartoukh Aude Gibelin Olivier Sanchez THOMAS SIMILOWSKI Claire Andrejak Valérie Chabbert Michel Djibré Sophie Tuffet Cendrine Godet Sandrine Pontier-Marchandise Julien Mayaux Marc Sapoval Vincent Le Pennec Marie-France Carette Clarisse Blayau Guillaume Voiriot Alexandre Duguet Hélène Prodanovik Guillaume Briend Anne Roche Costantino Del Giudice Olivier Pellerin Marie-Pierre Revel Patrick Courtheoux Jean Claude Meurice Elise Antone Alexandre Remond Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance BMJ Open Respiratory Research |
| title | Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
| title_full | Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
| title_fullStr | Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
| title_full_unstemmed | Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
| title_short | Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
| title_sort | randomised trial of first line bronchial artery embolisation for non severe haemoptysis of mild abundance |
| url | https://bmjopenrespres.bmj.com/content/8/1/e000949.full |
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