1. Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT
- Author
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Pinar Ulug, Robert J Hinchliffe, Michael J Sweeting, Manuel Gomes, Matthew T Thompson, Simon G Thompson, Richard J Grieve, Raymond Ashleigh, Roger M Greenhalgh, and Janet T Powell
- Subjects
abdominal aortic aneurysm ,rupture ,emergency surgery ,endovascular ,randomised trial ,Medical technology ,R855-855.5 - Abstract
Background: Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40–50% reported for open surgery. Objective: To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA. Design: Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1 : 1 ratio, using variable block size, stratified by centre and without blinding. Setting: Vascular centres in the UK (n = 29) and Canada (n = 1) between 2009 and 2013. Participants: A total of 613 eligible participants (480 men) with a ruptured aneurysm, clinically diagnosed at the trial centre. Interventions: A total of 316 participants were randomised to the endovascular strategy group (immediate computerised tomography followed by endovascular repair if anatomically suitable or, if not suitable, open repair) and 297 were randomised to the open repair group (computerised tomography optional). Main outcome measures: The primary outcome measure was 30-day mortality, with 30-day reinterventions, costs and disposal as early secondary outcome measures. Later outcome measures included 1- and 3-year mortality, reinterventions, quality of life (QoL) and cost-effectiveness. Results: The 30-day mortality was 35.4% in the endovascular strategy group and 37.4% in the open repair group [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.66 to 1.28; p = 0.62, and, after adjustment for age, sex and Hardman index, OR 0.94, 95% CI 0.67 to 1.33]. The endovascular strategy appeared to be more effective in women than in men (interaction test p = 0.02). More discharges in the endovascular strategy group (94%) than in the open repair group (77%) were directly to home (p
- Published
- 2018
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