{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T15:45:27Z","timestamp":1789832727357,"version":"4.0.1"},"reference-count":125,"publisher":"National Institute for Health and Care Research","issue":"31","license":[{"start":{"date-parts":[[2018,5,1]],"date-time":"2018-05-01T00:00:00Z","timestamp":1525132800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["07\/37\/64"],"award-info":[{"award-number":["07\/37\/64"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40\u201350% reported for open surgery.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title><jats:p>To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1\u2009:\u20091 ratio, using variable block size, stratified by centre and without blinding.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Vascular centres in the UK (<jats:italic>n<\/jats:italic>\u2009=\u200929) and Canada (<jats:italic>n<\/jats:italic>\u2009=\u20091) between 2009 and 2013.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>A total of 613 eligible participants (480 men) with a ruptured aneurysm, clinically diagnosed at the trial centre.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>A total of 316 participants were randomised to the endovascular strategy group (immediate computerised tomography followed by endovascular repair if anatomically suitable or, if not suitable, open repair) and 297 were randomised to the open repair group (computerised tomography optional).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome measure was 30-day mortality, with 30-day reinterventions, costs and disposal as early secondary outcome measures. Later outcome measures included 1- and 3-year mortality, reinterventions, quality of life (QoL) and cost-effectiveness.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>The 30-day mortality was 35.4% in the endovascular strategy group and 37.4% in the open repair group [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.66 to 1.28;<jats:italic>p<\/jats:italic>\u2009=\u20090.62, and, after adjustment for age, sex and Hardman index, OR 0.94, 95% CI 0.67 to 1.33]. The endovascular strategy appeared to be more effective in women than in men (interaction test<jats:italic>p<\/jats:italic>\u2009=\u20090.02). More discharges in the endovascular strategy group (94%) than in the open repair group (77%) were directly to home (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Average 30-day costs were similar between groups, with the mean difference in costs being \u2013\u00a31186 (95% CI \u2013\u00a32997 to \u00a3625), favouring the endovascular strategy group. After 1 year, survival and reintervention rates were similar in the two groups, QoL (at both 3 and 12 months) was higher in the endovascular strategy group and the mean cost difference was \u2013\u00a32329 (95% CI \u2013\u00a35489 to \u00a3922). At 3 years, mortality was 48% and 56% in the endovascular strategy group and open repair group, respectively (OR 0.73, 95% CI 0.53 to 1.00;<jats:italic>p<\/jats:italic>\u2009=\u20090.053), with a stronger benefit for the endovascular strategy in the subgroup of 502 participants in whom repair was started for a proven rupture (OR 0.62, 95% CI 0.43 to 0.89;<jats:italic>p<\/jats:italic>\u2009=\u20090.009), whereas aneurysm-related reintervention rates were non-significantly higher in this group. At 3 years, considering all participants, there was a mean difference of 0.174 quality-adjusted life-years (QALYs) (95% CI 0.002 to 0.353 QALYs) and, among the endovascular strategy group, a cost difference of \u2013\u00a32605 (95% CI \u2013\u00a35966 to \u00a3702), leading to 88% of estimates in the cost-effectiveness plane being in the quadrant showing the endovascular strategy to be \u2018dominant\u2019.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Because of the pragmatic design of this trial, 33 participants in the endovascular strategy group and 26 in the open repair group breached randomisation allocation.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title><jats:p>The endovascular strategy was not associated with a significant reduction in either 30-day mortality or cost but was associated with faster participant recovery. By 3 years, the endovascular strategy showed a survival and QALY gain and was highly likely to be cost-effective. Future research could include improving resuscitation for older persons with circulatory collapse, the impact of local anaesthesia and emergency consent procedures.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN48334791 and NCT00746122.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 22, No. 31. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta22310","type":"journal-article","created":{"date-parts":[[2018,6,4]],"date-time":"2018-06-04T08:48:26Z","timestamp":1528102106000},"page":"1-122","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":29,"title":["Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT"],"prefix":"10.3310","volume":"22","clinical-trial-number":[{"clinical-trial-number":"isrctn48334791","registry":"10.18810\/isrctn","type":"results"},{"clinical-trial-number":"nct00746122","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9719-1090","authenticated-orcid":true,"given":"Pinar","family":"Ulug","sequence":"first","affiliation":[{"name":"Vascular Surgery Research Group, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6370-0800","authenticated-orcid":true,"given":"Robert J","family":"Hinchliffe","sequence":"additional","affiliation":[{"name":"Bristol Centre for Surgical Research, Department of Surgical Sciences, University of Bristol, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0980-8965","authenticated-orcid":true,"given":"Michael J","family":"Sweeting","sequence":"additional","affiliation":[{"name":"Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1428-1232","authenticated-orcid":true,"given":"Manuel","family":"Gomes","sequence":"additional","affiliation":[{"name":"Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew T","family":"Thompson","sequence":"additional","affiliation":[{"name":"Vascular Surgery, St George\u2019s Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5274-7814","authenticated-orcid":true,"given":"Simon G","family":"Thompson","sequence":"additional","affiliation":[{"name":"Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8899-1301","authenticated-orcid":true,"given":"Richard J","family":"Grieve","sequence":"additional","affiliation":[{"name":"Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6706-8822","authenticated-orcid":true,"given":"Raymond","family":"Ashleigh","sequence":"additional","affiliation":[{"name":"Department of Radiology, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0867-0530","authenticated-orcid":true,"given":"Roger M","family":"Greenhalgh","sequence":"additional","affiliation":[{"name":"Vascular Surgery Research Group, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3905-1468","authenticated-orcid":true,"given":"Janet T","family":"Powell","sequence":"additional","affiliation":[{"name":"Vascular Surgery Research Group, Imperial College London, London, 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