A ruptured abdominal aortic aneurysm kills nearly half of patients who reach hospital, and a trial of 600 patients will test whether emergency keyhole surgery can cut that death rate by more than half. The standard treatment—open surgery through a large abdominal incision—carries a 47% in-hospital death rate and often requires long, costly hospital stays. Endovascular repair, where a stent-graft is threaded through an artery to seal the aneurysm from inside, has shown a 21% mortality in smaller studies, but it has never been tested in a large randomised trial. Only 55–60% of patients have arteries shaped to accept the device, so the trial will randomise twice as many patients to the endovascular strategy to gather enough data on who benefits. If the trial confirms the lower death rate, emergency endovascular repair could become the new standard across NHS vascular units, reducing deaths by hundreds per year and shortening hospital stays. The study also tracks costs, quality of life, and long-term survival, so funders will know whether the upfront expense of CT scanning and stent-grafts pays off in fewer intensive-care days and readmissions. The results could reshape how emergency vascular care is organised in the UK.
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DESIGN: Randomised controlled trial of patients with a clinical diagnosis of ruptured abdominal aortic aneurysm (AAA), randomised either to a strategy of preferential endovascular repair with immediate CT imaging or to normal care (open surgery, with or without diagnostic imaging studies ). Currently about 1300 English patients per annum undergo open repair of rAAA, often with long post-operative hospital stays, in-hospital mortality 47%. Endovascular repair offers the potential of lower mortality (21%), morbidity and cost. Since only 55-60% of patients will be anatomically suitable for endovascular repair, to optimise information about the new technology twice as many patients will be randomised to a strategy of endovascular repair compared with open repair. SETTING:A&E and vascular departments in 16-20 UK units offering 24/7 service for emergency endovascular aneurysm repair (eEVAR). Most centres have been identified and agreed to participate. All centres have high volumes of elective and emergency aneurysm surgery. TARGET POPULATION: 600 non-moribund patients with a clinical diagnosis of ruptured AAA . HEALTH TECHNOLOGIES BEING ASSESSED: (1) The efficacy and cost effectiveness of a strategy to repair ruptured AAA using endovascular techniques. (2) The use of immediate CT scanning to direct treatment of ruptured AAA. MEASUREMENT OF COSTS & OUTCOMES: The primary outcome will be in-hospital mortality. Secondary outcomes include survival at 24h, 30-days, 1 & 3 year after surgery, costs and cost-effectiveness at both 1 and 3 years.. Patients will be flagged at ONS to assess long-term survival and hospital data to 12 months will be collected by local vascular research co-ordinators. Other secondary outcome measures include the proportion of patients suitable for endovascular repair, complications, and patient disposal (proportion discharged home). Patients will be randomised over 27 months via telephone/internet system and stratified by age (above and below 76 years) with secure internet based data collection. There will be an algorithm for patient care including, resuscitation, anaesthesia, diagnostic and post-operative CT scans, which will be assessed in a core laboratory to facilitate assessment of the influence of aneurysm morphology on outcome. Modelling will be undertaken to indicate which patients benefit most from endovascular repair. Costs of the two strategies will be compared, with collection of costs for the primary admission as well as for hospital readmissions and use of community health services post discharge. The study will report the total hospital and community service costs for each group, and the incremental costs associated with the intervention. Health related quality of life (by EQ-5D) will be measured at 1 year follow-up and combined with survival, to report the incremental cost-effectiveness (cost per QALY). A cost-effectiveness model will be developed, that extrapolates from the 3 year trial endpoints to report long-term cost-effectiveness (5 years). Comparison of outcomes with contemporary national data bases could inform future policy directions in emergency vascular care. SAMPLE SIZE: A trial of 600 patients (with 400 randomised to a strategy of preferential endovascular repair) will have 90% power to detect a difference (at 5% significance) between in-hospital mortality of 21% (eEVAR) and 47% (open) . PROJECT TIMETABLE: Ethical application to IRAS submitted before June 2008. Staff recruitment, development of protocols, appointment of and first meetings of trial committees: July-September 2008. 1st April 2009: start of research project & employment of trial co-ordinator, followed by 3 months of training and run in, including local ethical and R&D approvals and e-training for A&E staff. September 2009-July 2013 inclusive: patient recruitment (30 centres, with final recruitment of 613 eligible patients). 30-day follow up for all patients was completed in August 2013, with reporting of results
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