Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial
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Published version
Author(s)
Type
Journal Article
Abstract
Objective To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm.
Design Randomised controlled trial.
Setting 30 vascular centres (29 UK, 1 Canadian), 2009-13.
Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm.
Interventions 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures).
Main outcome measures 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes.
Results 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval −£625 to £2997).
Conclusions A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women.
Design Randomised controlled trial.
Setting 30 vascular centres (29 UK, 1 Canadian), 2009-13.
Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm.
Interventions 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures).
Main outcome measures 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes.
Results 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval −£625 to £2997).
Conclusions A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women.
Date Issued
2014-01-13
Date Acceptance
2013-12-17
Citation
British Medical Journal, 2014, 348, pp.1-12
ISSN
1468-5833
Publisher
BMJ Publishing Group Ltd
Start Page
1
End Page
12
Journal / Book Title
British Medical Journal
Volume
348
Copyright Statement
© 2014 The Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.
Sponsor
Department of Health
National Institute for Health Research Health Technology Assessment Programme
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000329975600003&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
07/37/64
HTA project 07/37/64
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
MORTALITY
METAANALYSIS
Aged
Aged, 80 and over
Aneurysm, Ruptured
Aortic Aneurysm, Abdominal
Endovascular Procedures
Female
Hospital Costs
Hospital Mortality
Humans
Male
Odds Ratio
Outcome Assessment, Health Care
Patient Discharge
IMPROVE Trial Investigators
Humans
Aneurysm, Ruptured
Aortic Aneurysm, Abdominal
Patient Discharge
Hospital Mortality
Odds Ratio
Aged
Aged, 80 and over
Hospital Costs
Female
Male
Endovascular Procedures
Outcome Assessment, Health Care
General & Internal Medicine
1103 Clinical Sciences
1117 Public Health and Health Services
Publication Status
Published
Article Number
ARTN f7661
Date Publish Online
2014-01-13