Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial

<p><strong>Objective:</strong> The aim of the study was to compare long-term total and aneurysm-related mortality in physically frail patients with abdominal aortic aneurysm (AAA) randomized to either early endovascular aneurysm repair (EVAR) or no-intervention.</p> <p>...

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Main Authors: Sweeting, M, Patel, R, Powell, J, Greenhalgh, R, for the EVAR Trial Investigators
Other Authors: Halliday, A
Format: Journal article
Language:English
Published: Lippincott, Williams and Wilkins 2017
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author Sweeting, M
Patel, R
Powell, J
Greenhalgh, R
for the EVAR Trial Investigators
author2 Halliday, A
author_facet Halliday, A
Sweeting, M
Patel, R
Powell, J
Greenhalgh, R
for the EVAR Trial Investigators
author_sort Sweeting, M
collection OXFORD
description <p><strong>Objective:</strong> The aim of the study was to compare long-term total and aneurysm-related mortality in physically frail patients with abdominal aortic aneurysm (AAA) randomized to either early endovascular aneurysm repair (EVAR) or no-intervention.</p> <p><strong>Summary Background Data:</strong> EVAR-2 remains the sole randomized trial to identify whether EVAR reduces mortality in patients physically ineligible for open repair.</p> <p><strong>Methods:</strong> Between September 1999 and August 2004, 404 patients from 33 centers in the United Kingdom aged ≥60 years with AAA &gt;5.5 cm in diameter were randomized 1:1 using computer-generated sequences of randomly permuted blocks stratified by center to receive either EVAR (197) or no-intervention (207). The primary analysis compared total and aneurysm-related deaths in groups until June 30, 2015 (mean, 12.0 yrs; maximum 14.1 yrs).</p> <p><strong>Results:</strong> Mean follow-up until death or censoring was 4.2 years. There were 187 deaths (22.6 per 100 person-yrs) in the EVAR group and 194 (22.1 per 100 person-yrs) in the no-intervention group. By 12 years of follow-up the estimated survival was 5.3% [95% confidence interval (CI), 2.6–9.2] in the EVAR group and 8.5% (95% CI, 5.2–12.9) in the no-intervention group; there was no significant difference in life expectancy between the groups (both 4.2 yrs; P = 0.97). However, overall aneurysm-related mortality was significantly lower in the EVAR group [3.3 deaths per 100 person-yrs compared with 6.5 deaths per 100 person-yrs in the no-intervention group, adjusted hazard ratio 0.55 (95% CI, 0.34–0.91; P = 0.019)]. Patients surviving beyond 8 years were younger, with higher body mass index, estimated glomerular filtration rate, and forced expiratory volume in 1 second.</p> <p><strong>Conclusions:</strong> EVAR does not increase overall life expectancy in patients ineligible for open repair, but can reduce aneurysm-related mortality.</p>
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spelling oxford-uuid:e2d16784-f837-451e-9c02-05da70d749002022-03-27T10:04:16ZEndovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:e2d16784-f837-451e-9c02-05da70d74900EnglishSymplectic Elements at OxfordLippincott, Williams and Wilkins2017Sweeting, MPatel, RPowell, JGreenhalgh, Rfor the EVAR Trial InvestigatorsHalliday, A<p><strong>Objective:</strong> The aim of the study was to compare long-term total and aneurysm-related mortality in physically frail patients with abdominal aortic aneurysm (AAA) randomized to either early endovascular aneurysm repair (EVAR) or no-intervention.</p> <p><strong>Summary Background Data:</strong> EVAR-2 remains the sole randomized trial to identify whether EVAR reduces mortality in patients physically ineligible for open repair.</p> <p><strong>Methods:</strong> Between September 1999 and August 2004, 404 patients from 33 centers in the United Kingdom aged ≥60 years with AAA &gt;5.5 cm in diameter were randomized 1:1 using computer-generated sequences of randomly permuted blocks stratified by center to receive either EVAR (197) or no-intervention (207). The primary analysis compared total and aneurysm-related deaths in groups until June 30, 2015 (mean, 12.0 yrs; maximum 14.1 yrs).</p> <p><strong>Results:</strong> Mean follow-up until death or censoring was 4.2 years. There were 187 deaths (22.6 per 100 person-yrs) in the EVAR group and 194 (22.1 per 100 person-yrs) in the no-intervention group. By 12 years of follow-up the estimated survival was 5.3% [95% confidence interval (CI), 2.6–9.2] in the EVAR group and 8.5% (95% CI, 5.2–12.9) in the no-intervention group; there was no significant difference in life expectancy between the groups (both 4.2 yrs; P = 0.97). However, overall aneurysm-related mortality was significantly lower in the EVAR group [3.3 deaths per 100 person-yrs compared with 6.5 deaths per 100 person-yrs in the no-intervention group, adjusted hazard ratio 0.55 (95% CI, 0.34–0.91; P = 0.019)]. Patients surviving beyond 8 years were younger, with higher body mass index, estimated glomerular filtration rate, and forced expiratory volume in 1 second.</p> <p><strong>Conclusions:</strong> EVAR does not increase overall life expectancy in patients ineligible for open repair, but can reduce aneurysm-related mortality.</p>
spellingShingle Sweeting, M
Patel, R
Powell, J
Greenhalgh, R
for the EVAR Trial Investigators
Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title_full Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title_fullStr Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title_full_unstemmed Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title_short Endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair: Very long-term follow-up in the EVAR-2 randomized controlled trial
title_sort endovascular repair of abdominal aortic aneurysm in patients physically ineligible for open repair very long term follow up in the evar 2 randomized controlled trial
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