Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: One-year outcomes from the IMPROVE randomized trial
Braithwaite B., Greenhalgh RM., Grieve R., Hassan TB., Moore F., Nicholson AA., Soong CV., Heatley F., Anjum A., Kalinowska G., Gomes M., Powell JT., Hinchliffe R., Sweeting M., Thompson MM., Thompson SG., Ulug P., Roberts I., Bell PRF., Cheetham A., Stephany J., Halliday AW., Warlow C., Lamont P., Moss J., Tijssen J., Ashleigh R., Thompson M., Thompson L., Cheshire NJ., Boyle JR., Serracino-Inglott F., Hinchliffe RJ., Bell R., Wilson N., Bown M., Dennis M., Davis M., Howell S., Wyatt MG., Valenti D., Bachoo P., Walker P., MacSweeney S., Davies JN., Rittoo D., Parvin SD., Yusuf W., Nice C., Chetter I., Howard A., Chong P., Bhat R., McLain D., Gordon A., Lane I., Hobbs S., Pillay W., Rowlands T., El-Tahir A., Asquith J., Cavanagh S., Dubois L., Forbes TL., Ashworth E., Baker S., Barakat H., Brady C., Brown J., Bufton C., Chance T., Chrisopoulou A., Cockell M., Croucher A., Dabee L., Dewhirst N., Evans J., Gibson A., Gorst S., Gough M., Graves L., Griffin M., Hatfield J., Hogg F., Howard S., Hughes C., Metcalfe D., Lapworth M., Massey I., Novick T., Owen G., Parr N., Pintar D., Spencer S., Thomson C., Thunder O., Wallace T., Ward S., Wealleans V., Wilson L.
© 2015 The Author. Aims 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. Methods and results 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). Conclusion 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.