Title: Can emergency endovascular aneurysm repair (eEVAR) improves the survival from ruptured abdominal aortic aneurysm?
Funder: Department of Health (England)

Abstract: 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 in November 2013 to Vascular Society of Great Britain & Ireland and 2 publications in January 2014 (main trial BMJ [1] cohort analysis Br J Surg [2]). August 2014: 12 month follow up completed for all patients publications and reporting in late 2014-early 2015. Additional analyses for aortic morphology and outcome planned to report in autumn 2014 (with earlier presentation at Br Soc Endovasc Therapy at end June 2014) and an individual patient data meta-analysis with 2 smaller more selective European trials to report in early 2015.EXPERTISE IN TEAM: multi-disciplinary with clinicians (emergency care radiology vascular surgery & critical care) clinical trial experts including statistian and health economist core laboratory from previous collaborative trials in vascular intervention established network of collaborators patient surviving emergency endovascular repair of ruptured AAA.EXPECTED OUTPUT OF RESEARCH: presentations at professional societies (from autumn 2013) papers in general medical and surgical journals data to inform NICE guidelines HTA reportReferences1 IMPROVE trial investigators BMJ 2014;348:f76612 IMPROVE trial investigators Br J Surg 2014; 101: 216-224


Research activity codes: 6.4 SURGERY
Health categories: CARDIOVASCULAR