Quality of life from a randomized trial of open and endovascular repair for abdominal aortic aneurysm

Abstract

BACKGROUND: Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life (HRQoL) and health status. METHODS: Patients enrolled in a multicentre randomized clinical trial (DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair (EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36®) and EuroQol 5D (EQ-5D™). Physical (PCS) and mental component summary scores were also calculated. Follow-up was 5 years. RESULTS: Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR -1·98 (95 per cent c.i. -3·56 to -0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference -0·06 (-0·10 to -0·02) and -4·09 (-6·91 to -1·27) respectively. CONCLUSION: In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status.