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The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis

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Title: The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis
Authors: Patel, R
Powell, JT
Sweeting, MJ
Epstein, DM
Barrett, JK
Greenhalgh, RM
Item Type: Journal Article
Abstract: Background Short-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years. Objective To assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention. Design Two national, multicentre randomised controlled trials: EVAR-1 and EVAR-2. Setting Patients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004. Participants Men and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding. Interventions EVAR, OR or no intervention. Main outcome measures The primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness. Results In EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 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 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality; p = 0.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56, p = 0.048 for total mortality; HR 5.82, 95% CI 1.64 to 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, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (p < 0.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was £3798 (95% CI £2338 to £5258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient’s lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality. Limitations Devices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009. Conclusions EVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign. Future work To find easier ways to monitor sac expansion to trigger timely reintervention.
Issue Date: 1-Jan-2018
Date of Acceptance: 1-May-2017
URI: http://hdl.handle.net/10044/1/62147
DOI: https://dx.doi.org/10.3310/hta22050
ISSN: 1366-5278
Publisher: NIHR JOURNALS LIBRARY
Start Page: 1
End Page: +
Journal / Book Title: HEALTH TECHNOLOGY ASSESSMENT
Volume: 22
Issue: 5
Copyright Statement: © Queen’s Printer and Controller of HMSO 2018. This work was produced by Patel et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS.
Sponsor/Funder: Department of Health
National Institute for Health Research
Funder's Grant Number: 95/02/99
11/36/46
Keywords: Science & Technology
Life Sciences & Biomedicine
Health Care Sciences & Services
ABDOMINAL-AORTIC-ANEURYSM
CARDIOVASCULAR-DISEASE
RISK-FACTORS
II ENDOLEAK
SCREENING-PROGRAM
CLINICAL-TRIALS
PRESSURE MEASUREMENT
PRACTICE GUIDELINES
VASCULAR-SURGERY
BLOOD-PRESSURE
1117 Public Health And Health Services
0807 Library And Information Studies
0806 Information Systems
Health Policy & Services
Publication Status: Published
Online Publication Date: 2018-01-01
Appears in Collections:Department of Surgery and Cancer