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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Accepted version
Accepted version
Author(s)
Sweeting, MJ
Patel, R
Powell, JT
Greenhalgh, RM
EVAR Trial Investigators
Type
Journal Article
Abstract
OBJECTIVE: 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. SUMMARY BACKGROUND DATA: EVAR-2 remains the sole randomized trial to identify whether EVAR reduces mortality in patients physically ineligible for open repair. METHODS: Between September 1999 and August 2004, 404 patients from 33 centers in the United Kingdom aged ≥60 years with AAA >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). RESULTS: 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. CONCLUSIONS: EVAR does not increase overall life expectancy in patients ineligible for open repair, but can reduce aneurysm-related mortality.
Date Issued
2017-11-01
Date Acceptance
2017-11-01
Citation
Annals of Surgery, 2017, 266 (5), pp.713-719
ISSN
0003-4932
Publisher
Lippincott, Williams & Wilkins
Start Page
713
End Page
719
Journal / Book Title
Annals of Surgery
Volume
266
Issue
5
Copyright Statement
© 2017 Wolters Kluwer Health, Inc. All rights reserved.
Sponsor
National Institute for Health Research
Grant Number
11/36/46
Subjects
Aged
Aged, 80 and over
Aortic Aneurysm, Abdominal
Endovascular Procedures
Female
Follow-Up Studies
Humans
Life Expectancy
Male
Treatment Outcome
United Kingdom
Publication Status
Published