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Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.

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.

journal_name

BMJ

journal_title

BMJ (Clinical research ed.)

authors

IMPROVE Trial Investigators.,Powell JT,Sweeting MJ,Thompson MM,Ashleigh R,Bell R,Gomes M,Greenhalgh RM,Grieve R,Heatley F,Hinchliffe RJ,Thompson SG,Ulug P

doi

10.1136/bmj.f7661

subject

Has Abstract

pub_date

2014-01-13 00:00:00

pages

f7661

eissn

0959-8138

issn

1756-1833

journal_volume

348

pub_type

杂志文章,多中心研究,随机对照试验

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Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.