The EVAR-1 trial, published in 2004 and with long-term follow-up extending to 15 years, remains one of the most important studies in vascular surgery. Conducted across 37 UK centres, it randomised 1,082 patients with large abdominal aortic aneurysms (≥5.5 cm) who were fit for open repair to either endovascular repair (EVAR) or traditional open surgery.
The initial results were striking: 30-day operative mortality was significantly lower with EVAR (1.7% vs 4.7%). Patients recovered faster, spent fewer days in hospital, and reported better quality of life in the early months. EVAR appeared to be the clear winner.
However, the story became more nuanced with longer follow-up. By 8 years, the survival curves had converged completely. The early mortality advantage of EVAR was offset by a persistent rate of late complications and re-interventions. Endoleak, graft migration, and the need for secondary procedures meant that EVAR patients required lifelong surveillance.
At 15 years, there was actually a trend towards worse survival in the EVAR group, driven partly by aneurysm-related deaths from graft failure. The total cost of EVAR, including surveillance and re-interventions, was substantially higher than open repair.
The implications for practice are profound. EVAR-1 established that the choice between EVAR and open repair is not straightforward and must be individualised. It laid the groundwork for modern shared decision-making in AAA management and highlighted the importance of long-term follow-up in surgical trials.
For trainees preparing for the FRCS, understanding EVAR-1 is essential. It is likely to come up in the academic viva and is a model for how to critically appraise a surgical RCT with long-term follow-up data.