1. Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance
- Author
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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, 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, Service de Pneumologie - Oncologie Thoracique - Maladies Pulmonaires Rares [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Pneumologie - R3S [CHU Pitié-Salpêtrière] (SPMIR-R3S), CHU Pitié-Salpêtrière [AP-HP], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Unité de Recherche Clinique de l’Est Parisien [CHU Saint-Antoine] (URC-EST), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de pneumologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Université de Picardie Jules Verne (UPJV), Service de pneumologie [Toulouse], CHU Toulouse [Toulouse]-Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Service d'Anesthésie réanimation [CHU Tenon], Service de radiologie cardiovasculaire et interventionnelle [CHU Pitié-Salpêtrière], Service de Radiologie [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de Radiologie [CHU Caen], Service de Radiologie [CHU Tenon], Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), Service de Radiothérapie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP]
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Adult ,Pulmonary and Respiratory Medicine ,Hemoptysis ,medicine.medical_specialty ,Standard of care ,First line ,Bronchial Arteries ,Imaging/CT MRI etc ,Pulmonary Vasculature ,030218 nuclear medicine & medical imaging ,Diseases of the respiratory system ,03 medical and health sciences ,0302 clinical medicine ,Primary outcome ,Bronchoscopy ,medicine.artery ,medicine ,Humans ,Adverse effect ,Trial registration ,Retrospective Studies ,RC705-779 ,medicine.diagnostic_test ,Adult patients ,business.industry ,Embolization, Therapeutic ,3. Good health ,Surgery ,Treatment Outcome ,030228 respiratory system ,Medicine ,business ,Bronchial artery ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,Massive Haemoptysis - Abstract
BackgroundWhereas 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 questionTo assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methodsThis multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset ResultsBleeding 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.ConclusionIn 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 numberNCT01278199
- Published
- 2020