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Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial

Although endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patien... Full description

Journal Title: The Lancet (British edition) 2005, Vol.365 (9478), p.2179-2186
Main Author: CRONENWETT, Jack L
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: London: Elsevier Ltd
ID: ISSN: 0140-6736
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recordid: cdi_proquest_miscellaneous_67976245
title: Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial
format: Article
creator:
  • CRONENWETT, Jack L
subjects:
  • Abdominal aneurysm
  • Abridged Index Medicus
  • Aged
  • Aneurysms
  • Aortic Aneurysm, Abdominal - economics
  • Aortic Aneurysm, Abdominal - mortality
  • Aortic Aneurysm, Abdominal - surgery
  • Biological and medical sciences
  • Blood Vessel Prosthesis Implantation - adverse effects
  • Blood Vessel Prosthesis Implantation - economics
  • Blood Vessel Prosthesis Implantation - mortality
  • Care and treatment
  • Clinical trials
  • Comparative analysis
  • Diagnosis
  • Female
  • General aspects
  • Health care expenditures
  • Hospital Costs
  • Hospital Mortality
  • Humans
  • Male
  • Medical sciences
  • Medical treatment
  • Middle Aged
  • Mortality
  • Patient outcomes
  • Postoperative Complications
  • Quality of life
  • Risk Factors
  • Stents
  • Survival Rate
ispartof: The Lancet (British edition), 2005, Vol.365 (9478), p.2179-2186
description: Although endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large abdominal aortic aneurysm (AAA). We did a randomised controlled trial of 1082 patients aged 60 years or older who had aneurysms of at least 5·5 cm in diameter and who had been referred to one of 34 hospitals proficient in the EVAR technique. We assigned patients who were anatomically suitable for EVAR and fit for an open repair to EVAR (n=543) or open repair (n=539). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat. 94% (1017 of 1082) of patients complied with their allocated treatment and 209 died by the end of follow-up on Dec 31, 2004 (53 of aneurysm-related causes). 4 years after randomisation, all-cause mortality was similar in the two groups (about 28%; hazard ratio 0·90, 95% CI 0·69–1·18, p=0·46), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4% vs 7%; 0·55, 0·31–0·96, p=0·04). The proportion of patients with postoperative complications within 4 years of randomisation was 41% in the EVAR group and 9% in the open repair group (4·9, 3·5–6·8, p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
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descriptionAlthough endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large abdominal aortic aneurysm (AAA). We did a randomised controlled trial of 1082 patients aged 60 years or older who had aneurysms of at least 5·5 cm in diameter and who had been referred to one of 34 hospitals proficient in the EVAR technique. We assigned patients who were anatomically suitable for EVAR and fit for an open repair to EVAR (n=543) or open repair (n=539). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat. 94% (1017 of 1082) of patients complied with their allocated treatment and 209 died by the end of follow-up on Dec 31, 2004 (53 of aneurysm-related causes). 4 years after randomisation, all-cause mortality was similar in the two groups (about 28%; hazard ratio 0·90, 95% CI 0·69–1·18, p=0·46), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4% vs 7%; 0·55, 0·31–0·96, p=0·04). The proportion of patients with postoperative complications within 4 years of randomisation was 41% in the EVAR group and 9% in the open repair group (4·9, 3·5–6·8, p<0·0001). After 12 months there was negligible difference in HRQL between the two groups. The mean hospital costs per patient up to 4 years were UK£13 257 for the EVAR group versus £9946 for the open repair group (mean difference £3311, SE 690). Compared with open repair, EVAR offers no advantage with respect to all-cause mortality and HRQL, is more expensive, and leads to a greater number of complications and reinterventions. However, it does result in a 3% better aneurysm-related survival. The continuing need for interventions mandates ongoing surveillance and longer follow-up of EVAR for detailed cost-effectiveness assessment.
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subjectAbdominal aneurysm ; Abridged Index Medicus ; Aged ; Aneurysms ; Aortic Aneurysm, Abdominal - economics ; Aortic Aneurysm, Abdominal - mortality ; Aortic Aneurysm, Abdominal - surgery ; Biological and medical sciences ; Blood Vessel Prosthesis Implantation - adverse effects ; Blood Vessel Prosthesis Implantation - economics ; Blood Vessel Prosthesis Implantation - mortality ; Care and treatment ; Clinical trials ; Comparative analysis ; Diagnosis ; Female ; General aspects ; Health care expenditures ; Hospital Costs ; Hospital Mortality ; Humans ; Male ; Medical sciences ; Medical treatment ; Middle Aged ; Mortality ; Patient outcomes ; Postoperative Complications ; Quality of life ; Risk Factors ; Stents ; Survival Rate
ispartofThe Lancet (British edition), 2005, Vol.365 (9478), p.2179-2186
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descriptionAlthough endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large abdominal aortic aneurysm (AAA). We did a randomised controlled trial of 1082 patients aged 60 years or older who had aneurysms of at least 5·5 cm in diameter and who had been referred to one of 34 hospitals proficient in the EVAR technique. We assigned patients who were anatomically suitable for EVAR and fit for an open repair to EVAR (n=543) or open repair (n=539). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat. 94% (1017 of 1082) of patients complied with their allocated treatment and 209 died by the end of follow-up on Dec 31, 2004 (53 of aneurysm-related causes). 4 years after randomisation, all-cause mortality was similar in the two groups (about 28%; hazard ratio 0·90, 95% CI 0·69–1·18, p=0·46), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4% vs 7%; 0·55, 0·31–0·96, p=0·04). The proportion of patients with postoperative complications within 4 years of randomisation was 41% in the EVAR group and 9% in the open repair group (4·9, 3·5–6·8, p<0·0001). After 12 months there was negligible difference in HRQL between the two groups. The mean hospital costs per patient up to 4 years were UK£13 257 for the EVAR group versus £9946 for the open repair group (mean difference £3311, SE 690). Compared with open repair, EVAR offers no advantage with respect to all-cause mortality and HRQL, is more expensive, and leads to a greater number of complications and reinterventions. However, it does result in a 3% better aneurysm-related survival. The continuing need for interventions mandates ongoing surveillance and longer follow-up of EVAR for detailed cost-effectiveness assessment.
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4Aortic Aneurysm, Abdominal - economics
5Aortic Aneurysm, Abdominal - mortality
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17Health care expenditures
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20Humans
21Male
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23Medical treatment
24Middle Aged
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26Patient outcomes
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29Risk Factors
30Stents
31Survival Rate
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abstractAlthough endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large abdominal aortic aneurysm (AAA). We did a randomised controlled trial of 1082 patients aged 60 years or older who had aneurysms of at least 5·5 cm in diameter and who had been referred to one of 34 hospitals proficient in the EVAR technique. We assigned patients who were anatomically suitable for EVAR and fit for an open repair to EVAR (n=543) or open repair (n=539). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat. 94% (1017 of 1082) of patients complied with their allocated treatment and 209 died by the end of follow-up on Dec 31, 2004 (53 of aneurysm-related causes). 4 years after randomisation, all-cause mortality was similar in the two groups (about 28%; hazard ratio 0·90, 95% CI 0·69–1·18, p=0·46), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4% vs 7%; 0·55, 0·31–0·96, p=0·04). The proportion of patients with postoperative complications within 4 years of randomisation was 41% in the EVAR group and 9% in the open repair group (4·9, 3·5–6·8, p<0·0001). After 12 months there was negligible difference in HRQL between the two groups. The mean hospital costs per patient up to 4 years were UK£13 257 for the EVAR group versus £9946 for the open repair group (mean difference £3311, SE 690). Compared with open repair, EVAR offers no advantage with respect to all-cause mortality and HRQL, is more expensive, and leads to a greater number of complications and reinterventions. However, it does result in a 3% better aneurysm-related survival. The continuing need for interventions mandates ongoing surveillance and longer follow-up of EVAR for detailed cost-effectiveness assessment.
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