Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial

• Published in: European heart journal Vol. 36; no. 31; pp. 2061 - 2069
• Main Authors: Grieve, Richard, Sweeting, Michael J, Thompson, Simon G, Gomes, Manuel, Powell, Janet T, Ashleigh, Ray, Greenhalgh, Roger M, Hinchliffe, Robert J, Thompson, Matt M, Ulug, Pinar
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 14.08.2015
• Series: Editor's choice
• Subjects: Track Clinical Research; Aorta; Stent grafts; Cost-effectiveness; Surgery; Aneurysm; Rupture
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehv125

To report the longer term outcomes following either a strategy of endovascular repair first or open repair of ruptured abdominal aortic aneurysm, which are necessary for both patient and clinical decision-making. This pragmatic multicentre (29 UK and 1 Canada) trial randomized 613 patients with a clinical diagnosis of ruptured aneurysm; 316 to an endovascular first strategy (if aortic morphology is suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health-related quality-of-life (QoL) (EQ-5D), costs, Quality-Adjusted-Life-Years (QALYs), and cost-effectiveness [incremental net benefit (INB)]. At 1 year, all-cause mortality was 41.1% for the endovascular strategy group and 45.1% for the open repair group, odds ratio 0.85 [95% confidence interval (CI) 0.62, 1.17], P = 0.325, with similar re-intervention rates in each group. The endovascular strategy group and open repair groups had average total hospital stays of 17 and 26 days, respectively, P < 0.001. Patients surviving rupture had higher average EQ-5D utility scores in the endovascular strategy vs. open repair groups, mean differences 0.087 (95% CI 0.017, 0.158), 0.068 (95% CI -0.004, 0.140) at 3 and 12 months, respectively. There were indications that QALYs were higher and costs lower for the endovascular first strategy, combining to give an INB of £3877 (95% CI £253, £7408) or €4356 (95% CI €284, €8323). An endovascular first strategy for management of ruptured aneurysms does not offer a survival benefit over 1 year but offers patients faster discharge with better QoL and is cost-effective. ISRCTN 48334791.