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

Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial
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DOI:
10.1136/bmj.f7661
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发表时间:
2014-01-13
影响因子:
105.7
通讯作者:
Ulug, Pinar
Ulug, Pinar
中科院分区:
医学1区
文献类型:
--
作者:
Powell, Janet T.;Sweeting, Michael J.;Ulug, Pinar

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目的评估腔内修复术(如果主动脉形态合适,开放修复术)与开放修复术相比是否能降低疑似腹主动脉瘤破裂患者的早期死亡率。设计随机对照试验。设置30个血管中心(29个英国,1个加拿大),2009年至2013年。参与者613名符合条件的患者(480名男性),临床诊断为动脉瘤破裂。干预316例患者随机接受血管内策略(275例证实破裂,174例解剖结构适合腔内修复术)和297例开放修复术(261例证实破裂)。主要结果测量30天死亡率,24小时和住院死亡率,费用,结果30天死亡率在血管内策略组中为35.4%(112/316),在开放修复组中为37.4%(111/297):比值比0.92(95%可信区间0.66 ~ 1.28; P=0.62);校正年龄、性别和Hardman指数后的比值比0.94(0.67 ~ 1.33)。女性可能比男性从血管内策略中获益更多(相互作用检验P=0.02):比值比0.44(0.22 - 0.91)vs 1.18(0.80 - 1.75)。血管内策略组和开放性修复组中确认破裂患者的30天死亡率分别为36.4%(100/275)和40.6%(106/261)(P=0.31)。血管内治疗组直接出院回家的患者多于开放性修复组(189/201(94%)vs 141/183(77%); P
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