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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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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.
Authors: Sweeting, MJ
Patel, R
Powell, JT
Greenhalgh, RM
EVAR Trial Investigators
Item 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.
Issue Date: 1-Nov-2017
Date of Acceptance: 1-Nov-2017
URI: http://hdl.handle.net/10044/1/54315
DOI: https://dx.doi.org/10.1097/SLA.0000000000002392
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/Funder: National Institute for Health Research
Funder's Grant Number: 11/36/46
Keywords: Science & Technology
Life Sciences & Biomedicine
elective abdominal aortic aneurysm repair
patients physically ineligible for open abdominal aortic repair
the use of endovascular aneurysm repair (EVAR) in unfit patients
Aged, 80 and over
Aortic Aneurysm, Abdominal
Endovascular Procedures
Follow-Up Studies
Life Expectancy
Treatment Outcome
United Kingdom
EVAR Trial Investigators
11 Medical And Health Sciences
Publication Status: Published
Appears in Collections:Department of Surgery and Cancer