{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T17:08:22Z","timestamp":1790701702725,"version":"4.1.0"},"reference-count":165,"publisher":"National Institute for Health and Care Research","issue":"5","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"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":["15\/141\/04"],"award-info":[{"award-number":["15\/141\/04"]}],"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>Short-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title><jats:p>To assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>Two national, multicentre randomised controlled trials: EVAR-1 and EVAR-2.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Patients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Men and women aged \u2265\u200960 years with an aneurysm of \u2265\u20095.5\u2009cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1\u2009:\u20091 to either EVAR (<jats:italic>n<\/jats:italic>\u2009=\u2009626) or OR (<jats:italic>n<\/jats:italic>\u2009=\u2009626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (<jats:italic>n<\/jats:italic>\u2009=\u2009197) or no intervention (<jats:italic>n<\/jats:italic>\u2009=\u2009207) in EVAR-2. There was no blinding.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>EVAR, OR or no intervention.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>The primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>In EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27;<jats:italic>p<\/jats:italic>\u2009=\u20090.14]. At 0\u20136 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality;<jats:italic>p<\/jats:italic>\u2009=\u20090.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56,<jats:italic>p<\/jats:italic>\u2009=\u20090.048 for total mortality; HR 5.82, 95% CI 1.64 to 20.65,<jats:italic>p<\/jats:italic>\u2009=\u20090.0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (<jats:italic>p\u2009<\/jats:italic>&lt;\u20090.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was \u00a33798 (95% CI \u00a32338 to \u00a35258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient\u2019s lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Devices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title><jats:p>EVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title><jats:p>To find easier ways to monitor sac expansion to trigger timely reintervention.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN55703451.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and the results will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 22, No. 5. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta22050","type":"journal-article","created":{"date-parts":[[2018,1,31]],"date-time":"2018-01-31T11:16:48Z","timestamp":1517397408000},"page":"1-132","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":121,"title":["The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis"],"prefix":"10.3310","volume":"22","clinical-trial-number":[{"clinical-trial-number":"isrctn55703451","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0741-5343","authenticated-orcid":true,"given":"Rajesh","family":"Patel","sequence":"first","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, 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":"Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2275-0916","authenticated-orcid":true,"given":"David M","family":"Epstein","sequence":"additional","affiliation":[{"name":"Centre for Health Economics, University of York, York, UK"},{"name":"Department of Applied Economics, University of Granada, Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1889-9803","authenticated-orcid":true,"given":"Jessica K","family":"Barrett","sequence":"additional","affiliation":[{"name":"Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, 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"}]}],"member":"6221","published-online":{"date-parts":[[2018,1]]},"reference":[{"key":"key20180129140827972_ref1-bib1","doi-asserted-by":"crossref","first-page":"613","DOI":"10.1016\/S0140-6736(88)90649-6","article-title":"Oxford screening programme for abdominal aortic aneurysm in men aged 65 to 74 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