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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

Sweeting, Michael J. PhD*; Patel, Rajesh PhD; Powell, Janet T. MD; Greenhalgh, Roger M. MDfor the EVAR Trial Investigators

doi: 10.1097/SLA.0000000000002392
ESA-RANDOMIZED CONTROLLED TRIALS
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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.

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*Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom

Vascular Surgery Research Group, Imperial College London, London, United Kingdom.

Reprints: Roger M. Greenhalgh, MD, Vascular Surgery Research Group, Imperial College London, London, United Kingdom. E-mail: r.greenhalgh@imperial.ac.uk.

This study was funded by the National Institute (NIHR) for Health Research Health Technology Assessment program (HTA). Supportive funding was received from the Camelia Botnar Arterial Foundation. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA program, NIHR, UK National Health Service, or the UK Department of Health.

The authors report no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.annalsofsurgery.com).

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