Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial

EVAR Trial Investigators

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Abstract

Background Short-term survival benefits of endovascular aneurysm repair (EVAR) versus open repair of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is lost after a few years. We investigated whether EVAR had a long-term survival benefit compared with open repair. Methods We used data from the EVAR randomised controlled trial (EVAR trial 1), which enrolled 1252 patients from 37 centres in the UK between Sept 1, 1999, and Aug 31, 2004. Patients had to be aged 60 years or older, have aneurysms of at least 5·5 cm in diameter, and deemed suitable and fit for either EVAR or open repair. Eligible patients were randomly assigned (1:1) using computer-generated sequences of randomly permuted blocks stratified by centre to receive either EVAR (n=626) or open repair (n=626). Patients and treating clinicians were aware of group assignments, no masking was used. The primary analysis compared total and aneurysm-related deaths in groups until mid-2015 in the intention-to-treat population. This trial is registered at ISRCTN (ISRCTN55703451). Findings We recruited 1252 patients between Sept 1, 1999, and Aug 31, 2004. 25 patients (four for mortality outcome) were lost to follow-up by June 30, 2015. Over a mean of 12·7 years (SD 1·5; maximum 15·8 years) of follow-up, we recorded 9·3 deaths per 100 person-years in the EVAR group and 8·9 deaths per 100 person-years in the open-repair group (adjusted hazard ratio [HR] 1·11, 95% CI 0·97–1·27, p=0·14). At 0–6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0·61, 95% CI 0·37–1·02 for total mortality; and 0·47, 0·23–0·93 for aneurysm-related mortality, p=0·031), but beyond 8 years of follow-up open-repair had a significantly lower mortality (adjusted HR 1·25, 95% CI 1·00–1·56, p=0·048 for total mortality; and 5·82, 1·64–20·65, p=0·0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture (13 deaths [7%] in EVAR vs two [1%] in open repair), with increased cancer mortality also observed in the EVAR group. Interpretation EVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and re-intervention if necessary. Funding UK National Institute for Health Research, Camelia Botnar Arterial Research Foundation.

Original languageEnglish
Pages (from-to)2366-2374
Number of pages9
JournalThe Lancet
Volume388
Issue number10058
DOIs
Publication statusPublished - 12 Nov 2016
Externally publishedYes

Bibliographical note

Funding Information:
MJS reports grants from the National Institute for Health Research, during the conduct of the study. RMG serves as a salaried director of BIBA Medical and has an equity interest in the company, and also serves as an expert witness on behalf of patients with vascular disease. RP and JTP declare no competing interests.

Funding Information:
This study was funded by the National Institute (NIHR) for Health Research Health Technology Assessment programme (HTA) and Camelia Botnar Arterial Research Foundation. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, UK National Health Service, or the UK Department of Health. Work done at the Cardiovascular Epidemiology Unit, University of Cambridge, was additionally funded by the UK Medical Research Council (MR/L003120/1), British Heart Foundation (RG/13/13/30194) and UK National Institute for Health Research Cambridge Biomedical Research Centre. Data were gathered by trial centres and the trial managers Louise Brown (1999 to 2010). We thank Sir Miles Irving, director of NHS Health Technology Assessment Programme 1993–1999, for championing the funding of devices solely within the context of a randomised controlled trial; Louise Brown, EVAR trials 1 and 2 trial manager 1999–2010; and Philip Poole-Wilson, chairman of the Data Monitoring and Ethical Committee 1999–2009, in helping to achieve ongoing study funding.

Publisher Copyright:
© 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license

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