Elsevier

The Lancet

Volume 365, Issue 9478, 25 June–1 July 2005, Pages 2179-2186
The Lancet

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

https://doi.org/10.1016/S0140-6736(05)66627-5Get rights and content

Summary

Background

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).

Methods

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.

Findings

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).

Interpretation

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.

Introduction

Endovascular aneurysm repair (EVAR) offers a short-term benefit over open repair for the management of large abdominal aortic aneurysms (AAA).1, 2 However, data from registries—eg, EUROSTAR (European Collaborators Registry on Stent-graft Techniques for AAA Repair) and RETA (Registry for Endovascular Treatment of Aneurysms)3, 4—indicate the need for close surveillance of endografts over many years, since complications arise in 25–40% of patients who often need additional interventions or conversion to open surgery.5, 6 As the technology of EVAR develops, graft durability should improve and the number of complications reported should fall.7

Trials with a similar protocol to EVAR trial 1 are underway in the Netherlands (DREAM), France (ACE), and the USA (OVER).8 The most advanced of these, the Dutch DREAM trial,2, 9 has focused on short-term combined mortality and morbidity outcomes, and preliminary results suggest that EVAR is not associated with an enduring improvement in health-related quality of life (HRQL) at 12 months.9 Other studies10 suggest that EVAR is more expensive than open repair.

Our aim was to assess longterm survival, generalisability, graft durability, HRQL, and hospital costs associated with both EVAR and open repair. Midterm results are presented.

Section snippets

Methods

The detailed methods for EVAR trial 1 have been published.11 Briefly, recruitment into the trial began on Sept 1, 1999, with 13 eligible UK hospitals. We regarded hospitals as eligible when they had completed 20 EVAR procedures and submitted the data to RETA.4 During the subsequent 4 years the number of hospitals that had sufficient experience with EVAR increased to 41, though only 34 of these had entered patients into EVAR trial 1 by the end of planned recruitment on Dec 31, 2003. Trained

Results

Between September, 1999, and December, 2003, 34 centres registered 4799 patients for consideration for entry into either EVAR trial 1 or 2. Figure 1 shows the trial profile. 1423 patients were eligible; 341 refused to be randomised. Patients who refused were similar to those randomised in terms of their mean age (74 years, SD 7) and the proportion who were men (89%, n=302), but their aneurysm diameter was slightly greater (median 64 cm, IQR 5·9–7·0, p=0·02).

Table 1 of the first EVAR report1

Discussion

Our midterm results for all-cause and aneurysm-related mortality, together with post-operative complications and reinterventions, HRQL, and hospital costs begin to provide the information from which clinical guidelines might emanate. After 4 years, all-cause mortality did not differ between patients randomised to EVAR and those randomised to open repair of AAA, despite an initial postoperative benefit of EVAR. However, there was a significant difference in the aneurysm-related mortality at 4

References (29)

  • SR Vallabhaneni et al.

    Lessons learnt from the EUROSTAR registry on endovascular repair of abdominal aortic aneurysm

    Eur J Radiol

    (2001)
  • MD Kertai et al.

    Association between long-term statin use and mortality after successful abdominal aortic aneurysm surgery

    Am J Med

    (2004)
  • Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial

    Lancet

    (2004)
  • M Prinssen et al.

    A randomised trial comparing conventional and endovascular repair of abdominal aortic aneurysms

    N Engl J Med

    (2004)
  • SM Thomas et al.

    Results from the Prospective Registry of Endovascular Treatment of Abdominal Aortic Aneurysms (RETA): mid term results to five years

    Eur J Vasc Endovasc Surg

    (2005)
  • PL Harris et al.

    Incidence and risk factors of late rupture, conversion and death after endovascular repair of infrarenal aortic aneurysms the EUROSTAR experience

    J Vasc Surg

    (2000)
  • CJ Van Marrewijk et al.

    Significance of endoleaks after endovascular repair of abdominal aortic aneurysms: the EUROSTAR experience

    J Vasc Surg

    (2002)
  • TorellaE

    Effect of improved design on outcome of endovascular aneurysm repair

    J Vasc Surg

    (2004)
  • LC Brown et al.

    Overview of the current European randomised aortic stent graft trials

  • M Prinssen et al.

    Quality of life after endovascular and open AAA repair: results of a randomised trial

    Eur J Vasc Endovasc Surg

    (2002)
  • WC Sternbergh et al.

    Hospital cost of endovascular versus open repair of abdominal aortic aneurysms: a multicenter study

    J Vasc Surg

    (2000)
  • LC Brown et al.

    The UK EndoVascular Aneurysm Repair (EVAR) Trials: design, methodology and progress

    Eur J Vasc Endovasc Surg

    (2004)
  • Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial

    Lancet

    (2005)
  • WHO

    International statistical classification of diseases and related health problems

    (1996)
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