A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm - results of a pilot study and lessons learned for future studies.

INTRODUCTION: EVAR has the potential to improve outcome after ruptured abdominal aortic aneurysm (AAA). Published series have been based upon selected populations.
METHODS: An interim analysis of a single centre prospective randomised controlled trial comparing endovascular aneurysm repair (EVAR) with open aneurysm repair (OAR) in patients with ruptured AAA was performed. Patients who had a ruptured AAA and who were considered fit for open repair were randomised to EVAR or OAR after consent had been obtained. Those in the EVAR group had pre-operative spiral computed tomographic angiography (CTA). The primary endpoint was operative (30-day) mortality and secondary endpoints were moderate or severe operative complications, hospital stay and time between diagnosis and operation. A power study calculation required 100 patients to be recruited.
RESULTS: Between September 2002 and December 2004, 103 patients were admitted with suspected ruptured AAA. Only 32 patients were recruited to the study. Of these, four patients died before receiving surgical treatment. On an intention to treat basis the 30-day mortality rate was 53% in the EVAR group and 53% in the OAR group. Moderate or severe operative complications occurred in 77% in the EVAR group and in 80% in the OAR group. Median total hospital stay in the EVAR group was 10 days (inter-quartile range 6-28) and 12 days (4-52) in the OAR group. Median time between diagnosis and operation was 75 minutes (64-126) in the EVAR group and 100 minutes (48-138) in the OAR group.
CONCLUSIONS: Despite the relative high operative mortality in the EVAR group, these preliminary results show that it is possible to recruit patients to a randomised trial of OAR and EVAR in patients with ruptured AAA. CT scanning does not delay treatment.

RCT Entities:   Population Interventions Outcomes