Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:8 |
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| Enthalten in: |
BMJ open respiratory research - 8(2021), 1 vom: 01. Juni |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fartoukh, Muriel [VerfasserIn] |
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| Links: |
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| Themen: |
Bronchoscopy |
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| Anmerkungen: |
Date Completed 28.10.2021 Date Revised 28.10.2021 published: Print ClinicalTrials.gov: NCT01278199 Citation Status MEDLINE |
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| doi: |
10.1136/bmjresp-2021-000949 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM326369805 |
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| 245 | 1 | 0 | |a Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance |
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| 500 | |a Date Completed 28.10.2021 | ||
| 500 | |a Date Revised 28.10.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01278199 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a RESEARCH QUESTION: To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT01278199 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Bronchoscopy | |
| 650 | 4 | |a Imaging/CT MRI etc | |
| 650 | 4 | |a Massive Haemoptysis | |
| 700 | 1 | |a Demoule, Alexandre |e verfasserin |4 aut | |
| 700 | 1 | |a Sanchez, Olivier |e verfasserin |4 aut | |
| 700 | 1 | |a Tuffet, Sophie |e verfasserin |4 aut | |
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| 700 | 1 | |a Sapoval, Marc |e verfasserin |4 aut | |
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| 700 | 1 | |a Cadranel, Jacques |e verfasserin |4 aut | |
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| 700 | 1 | |a Blayau, Clarisse |e investigator |4 oth | |
| 700 | 1 | |a Voiriot, Guillaume |e investigator |4 oth | |
| 700 | 1 | |a Similowski, Thomas |e investigator |4 oth | |
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| 700 | 1 | |a Meurice, Jean Claude |e investigator |4 oth | |
| 700 | 1 | |a Antone, Elise |e investigator |4 oth | |
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