Conservative versus Interventional Treatment for Spontaneous Pneumothorax.
Adolescent
Adult
Chest Tubes
Conservative Treatment
Drainage
/ methods
Female
Follow-Up Studies
Humans
Length of Stay
Male
Middle Aged
Patient Readmission
/ statistics & numerical data
Pneumothorax
/ diagnostic imaging
Postoperative Complications
Radiography, Thoracic
Recurrence
Treatment Outcome
Watchful Waiting
Young Adult
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
30 01 2020
30 01 2020
Historique:
entrez:
30
1
2020
pubmed:
30
1
2020
medline:
6
2
2020
Statut:
ppublish
Résumé
Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks. A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, -4.1 percentage points; 95% confidence interval [CI], -8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of -9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of -11.0 percentage points (95% CI, -18.4 to -3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management. Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).
Sections du résumé
BACKGROUND
Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown.
METHODS
In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks.
RESULTS
A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, -4.1 percentage points; 95% confidence interval [CI], -8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of -9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of -11.0 percentage points (95% CI, -18.4 to -3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management.
CONCLUSIONS
Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).
Identifiants
pubmed: 31995686
doi: 10.1056/NEJMoa1910775
doi:
Banques de données
ANZCTR
['ACTRN12611000184976']
Types de publication
Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
405-415Subventions
Organisme : National Health and Medical Research Council
ID : 1084941
Pays : International
Organisme : Health Research Council of New Zealand
ID : 11/603, 18/1002
Pays : International
Organisme : Royal Perth Hospital Medical Research Foundation
ID : 2011
Pays : International
Organisme : State Health Research Advisory Council
ID : F-AA-12440
Pays : International
Organisme : Emergency Medicine Foundation
ID : EMSS-12-190
Pays : International
Investigateurs
David McCutcheon
(D)
Stephen MacDonald
(S)
Adam Coulson
(A)
Hugh Mitenko
(H)
Phil Chapman
(P)
Sandra Rennie
(S)
Sophie Damianopoulos
(S)
Cathy Read
(C)
Glenn Arendts
(G)
Yusuf Nagree
(Y)
Ranjan Shrestha
(R)
Emma Ball
(E)
Paula Johnston
(P)
Peter Kendall
(P)
Vahid Moosavi
(V)
Matthew Summerscales
(M)
Rod Ellis
(R)
Leanne Hartnett
(L)
Daniel Fatovich
(D)
Miranda Smith
(M)
Claire Tobin
(C)
Tor Ercleve
(T)
Claire Falzon
(C)
Edward Fysh
(E)
Gary Lee
(G)
David Mountain
(D)
Nicole Ghedina
(N)
David Manners
(D)
Francesco Piccolo
(F)
Susan Mills
(S)
Amanda Stafford
(A)
Paul Buntine
(P)
Andrew Maclean
(A)
Julia Ng
(J)
Ali Asadpour
(A)
Gaby Blecher
(G)
Simon Craig
(S)
Diana Egerton-Warburton
(D)
Andis Graudins
(A)
Barton Jennings
(B)
Robert Meek
(R)
Alastair Meyer
(A)
Kirsty Povey
(K)
Rachel Rosler
(R)
Julian Smith
(J)
Kathryn Wilson
(K)
Simon Brown
(S)
Geoffrey Couser
(G)
John Dewing
(J)
Pradeep Bambery
(P)
Michael Chang
(M)
Greg Treston
(G)
Gerben Keijzers
(G)
Toby Tang
(T)
Kylie Baker
(K)
Adel Braasch
(A)
Deepak Doshi
(D)
Simon Bowler
(S)
David Serisier
(D)
Joseph Ting
(J)
Michael Bint
(M)
John Fuller
(J)
Ogilvie Thom
(O)
Yusuke Ueno-Dewhirst
(Y)
Kevin Chu
(K)
Duncan McAuley
(D)
Christopher Zappala
(C)
Mark Little
(M)
Graham Simpson
(G)
Stephen Vincent
(S)
Frances Kinnear
(F)
Philip Masel
(P)
Jeremy Furyk
(J)
Huang-Liang Lee
(HL)
Anthony Matthieson
(A)
Simon Tebbutt
(S)
Kathleen Hyland
(K)
Ross Sellars
(R)
Reza Ali
(R)
James Kwan
(J)
David Arnold
(D)
Conrad Loten
(C)
Mark Gillett
(M)
Michael Hibbert
(M)
Stephen Asha
(S)
Steven Lindstrom
(S)
Allison Moore
(A)
Ben Kwan
(B)
David Mah
(D)
Peter Jones
(P)
Margaret Wilsher
(M)
Lutz Beckert
(L)
Jeff Garrett
(J)
Hamish Read
(H)
Catherina L Chang
(CL)
Hollie Ellis
(H)
Robert J Hancox
(RJ)
George Bardsley
(G)
Richard Beasley
(R)
Kyle Perrin
(K)
Sharon Power
(S)
Commentaires et corrections
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Informations de copyright
Copyright © 2020 Massachusetts Medical Society.