Comparative clinical effectiveness and cost-effectiveness of an endovascular strategy versus open repair for ruptured abdomina aortic aneurysm: 3-year results of the IMPROVE randomised trial

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Title: Comparative clinical effectiveness and cost-effectiveness of an endovascular strategy versus open repair for ruptured abdomina aortic aneurysm: 3-year results of the IMPROVE randomised trial
Authors: Powell, JT
IMPROVE Trail Investigators
Item Type: Journal Article
Abstract: Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm. Design Randomised controlled trial. Setting 30 vascular centres (29 in UK, one in Canada), 2009-16. Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture. Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture). Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures. Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of −£2605 (95% confidence interval −£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain. Conclusions At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair. Trial registration Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122.
Issue Date: 14-Nov-2017
Date of Acceptance: 11-Oct-2017
URI: http://hdl.handle.net/10044/1/54314
DOI: https://dx.doi.org/10.1136/bmj.j4859
ISSN: 0959-8138
Publisher: BMJ Publishing Group
Journal / Book Title: British Medical Journal
Volume: 359
Copyright Statement: © 2017 The Author(s). This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
Sponsor/Funder: Department of Health
National Institute for Health Research Health Technology Assessment Programme
Funder's Grant Number: 07/37/64
HTA project 07/37/64
Keywords: 1117 Public Health And Health Services
General & Internal Medicine
Publication Status: Published
Article Number: j4859
Appears in Collections:Department of Surgery and Cancer