Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial
IMPROVE Trial Investigators, Janet T Powell, Michael J Sweeting, Matthew M Thompson, Ray Ashleigh, Rachel Bell, Manuel Gomes, Roger M Greenhalgh, Richard Grieve, Francine Heatley, Robert J Hinchliffe, Simon G Thompson, Pinar Ulug, Janet T Powell, Bruce Braithwaite, Nicholas J Cheshire, Roger M Greenhalgh, Richard J Grieve, Tajek B Hassan, Robert Hinchliffe, Simon Howell, Fionna Moore, Anthony A Nicholson, Chee V Soong, Matt M Thompson, Simon G Thompson, Pinar Ulug, Francine Heatley, Aisha Anjum, Michael J Sweeting, Simon G Thompson, Manuel Gomes, Richard J Grieve, Janet T Powell, Ray Ashleigh, Manuel Gomes, Roger M Greenhalgh, Richard Grieve, Robert Hinchliffe, Michael Sweeting, Matt M Thompson, Simon G Thompson, Pinar Ulug, Francine Heatley, Ian Roberts, Peter R F Bell, Anne Cheetham, Jenny Stephany, Alison Halliday, Charles Warlow, Peter Lamont, Jonathan Moss, Jan Tijssen, Bruce Braithwaite, Anthony A Nicholson, Matthew Thompson, Ray Ashleigh, Luke Thompson, Nicholas J Cheshire, Jonathan R Boyle, Ferdinand Serracino-Inglott, J Vince Smyth, Matt M Thompson, Robert J Hinchliffe, Rachel Bell, Noel Wilson, Matt Bown, Martin Dennis, Meryl Davis, Ray Ashleigh, Simon Howell, Michael G Wyatt, Domenico Valenti, Paul Bachoo, Paul Walker, Shane MacSweeney, Jonathan N Davies, Dynesh Rittoo, Simon D Parvin, Waquar Yusuf, Colin Nice, Ian Chetter, Adam Howard, Patrick Chong, Raj Bhat, David McLain, Andrew Gordon, Ian Lane, Simon Hobbs, Woolagasen Pillay, Timothy Rowlands, Amin El-Tahir, John Asquith, Steve Cavanagh, Thomas L Forbes, Ayoola Awopetu, Sara Baker, Patricia Bourke, Claire Brady, Joanne Brown, Jennie Bryce, Christine Bufton, Tina Chance, Angela Chrisopoulou, Marie Cockell, Andrea Croucher, Gail Curran, Leela Dabee, Nikki Dewhirst, Jo Evans, Andy Gibson, Siobhan Gorst, Moira Gough, Lynne Graves, Michelle Griffin, Josie Hatfield, Florence Hogg, Susannah Howard, Thomas Hughes, Alex James, David Metcalfe, Michelle Lapworth, Ian Massey, Awad Mohalhal, Teresa Novick, Gareth Owen, Noala Parr, David Pintar, Tom Smith, Sarah Spencer, Claire Thomson, Orla Thunder, Tom Wallace, Sue Ward, Vera Wealleans, Lesley Wilson, Janet Woods, Manu Zachariah, Ting Zheng, IMPROVE Trial Investigators, Janet T Powell, Michael J Sweeting, Matthew M Thompson, Ray Ashleigh, Rachel Bell, Manuel Gomes, Roger M Greenhalgh, Richard Grieve, Francine Heatley, Robert J Hinchliffe, Simon G Thompson, Pinar Ulug, Janet T Powell, Bruce Braithwaite, Nicholas J Cheshire, Roger M Greenhalgh, Richard J Grieve, Tajek B Hassan, Robert Hinchliffe, Simon Howell, Fionna Moore, Anthony A Nicholson, Chee V Soong, Matt M Thompson, Simon G Thompson, Pinar Ulug, Francine Heatley, Aisha Anjum, Michael J Sweeting, Simon G Thompson, Manuel Gomes, Richard J Grieve, Janet T Powell, Ray Ashleigh, Manuel Gomes, Roger M Greenhalgh, Richard Grieve, Robert Hinchliffe, Michael Sweeting, Matt M Thompson, Simon G Thompson, Pinar Ulug, Francine Heatley, Ian Roberts, Peter R F Bell, Anne Cheetham, Jenny Stephany, Alison Halliday, Charles Warlow, Peter Lamont, Jonathan Moss, Jan Tijssen, Bruce Braithwaite, Anthony A Nicholson, Matthew Thompson, Ray Ashleigh, Luke Thompson, Nicholas J Cheshire, Jonathan R Boyle, Ferdinand Serracino-Inglott, J Vince Smyth, Matt M Thompson, Robert J Hinchliffe, Rachel Bell, Noel Wilson, Matt Bown, Martin Dennis, Meryl Davis, Ray Ashleigh, Simon Howell, Michael G Wyatt, Domenico Valenti, Paul Bachoo, Paul Walker, Shane MacSweeney, Jonathan N Davies, Dynesh Rittoo, Simon D Parvin, Waquar Yusuf, Colin Nice, Ian Chetter, Adam Howard, Patrick Chong, Raj Bhat, David McLain, Andrew Gordon, Ian Lane, Simon Hobbs, Woolagasen Pillay, Timothy Rowlands, Amin El-Tahir, John Asquith, Steve Cavanagh, Thomas L Forbes, Ayoola Awopetu, Sara Baker, Patricia Bourke, Claire Brady, Joanne Brown, Jennie Bryce, Christine Bufton, Tina Chance, Angela Chrisopoulou, Marie Cockell, Andrea Croucher, Gail Curran, Leela Dabee, Nikki Dewhirst, Jo Evans, Andy Gibson, Siobhan Gorst, Moira Gough, Lynne Graves, Michelle Griffin, Josie Hatfield, Florence Hogg, Susannah Howard, Thomas Hughes, Alex James, David Metcalfe, Michelle Lapworth, Ian Massey, Awad Mohalhal, Teresa Novick, Gareth Owen, Noala Parr, David Pintar, Tom Smith, Sarah Spencer, Claire Thomson, Orla Thunder, Tom Wallace, Sue Ward, Vera Wealleans, Lesley Wilson, Janet Woods, Manu Zachariah, Ting Zheng
Abstract
Objective: To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm.
Design: Randomised controlled trial.
Setting: 30 vascular centres (29 UK, 1 Canadian), 2009-13.
Participants: 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm.
Interventions: 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures).
Main outcome measures: 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes.
Results: 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval -£625 to £2997).
Conclusions: A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women.
Trial registration: Current Controlled Trials ISRCTN48334791.
Source: PubMed