Fast track — ArticlesEndovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial
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)
- et al.
Lessons learnt from the EUROSTAR registry on endovascular repair of abdominal aortic aneurysm
Eur J Radiol
(2001) - 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)- et al.
A randomised trial comparing conventional and endovascular repair of abdominal aortic aneurysms
N Engl J Med
(2004) - 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) - 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) - et al.
Significance of endoleaks after endovascular repair of abdominal aortic aneurysms: the EUROSTAR experience
J Vasc Surg
(2002) Effect of improved design on outcome of endovascular aneurysm repair
J Vasc Surg
(2004)- et al.
Overview of the current European randomised aortic stent graft trials
- et al.
Quality of life after endovascular and open AAA repair: results of a randomised trial
Eur J Vasc Endovasc Surg
(2002)
Hospital cost of endovascular versus open repair of abdominal aortic aneurysms: a multicenter study
J Vasc Surg
The UK EndoVascular Aneurysm Repair (EVAR) Trials: design, methodology and progress
Eur J Vasc Endovasc Surg
Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial
Lancet
International statistical classification of diseases and related health problems
Cited by (1270)
Editor's Choice – European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms
2024, European Journal of Vascular and Endovascular SurgeryComputational prediction of proximal sealing in endovascular abdominal aortic aneurysm repair with unfavorable necks
2024, Computer Methods and Programs in BiomedicineComprehensive framework of factors accounting for worse aortic aneurysm outcomes in females: A scoping review
2023, Seminars in Vascular Surgery2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines
2023, Journal of Thoracic and Cardiovascular SurgerySemi-Conservative Treatment Versus Radical Surgery in Abdominal Aortic Graft and Endograft Infections
2023, European Journal of Vascular and Endovascular Surgery
- *
Trial participants listed at end of paper