Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial
Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial
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DOI：
10.1093/eurheartj/ehv125
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发表时间：
2015-08-14
影响因子：
39.3
通讯作者：
Powell, Janet T.
中科院分区：
文献类型：
--
作者：
Grieve, Richard;Gomes, Manuel;Powell, Janet T.
目的报告腹主动脉瘤破裂后，无论是腔内修复术还是开放修复术的长期结果，这对患者和临床决策都是必要的。（29例英国和1例加拿大）试验随机分配了613例临床诊断为破裂动脉瘤的患者; 316例为血管内首选策略（如果主动脉形态合适，则开放修复），297例为开放修复。主要1年结局为死亡率;次要结局为再次干预、出院、健康相关生活质量（QoL）（EQ-5D）、成本、质量调整生命年（QOL）和成本-效果[增量净获益（INB）]。1年时，血管内策略组的全因死亡率为41.1%，开放修复组为45.1%，比值比为0.85 [95%置信区间（CI）0.62，1.17]，P = 0.325，两组的再介入率相似。血管内策略组和开放修复组的平均总住院时间分别为17天和26天，P < 0.001。血管内策略组与开放修复组相比，破裂存活患者的平均EQ-5D效用评分更高，3个月和12个月时的平均差异分别为0.087（95% CI 0.017，0.158）和0.068（95% CI-0.004，0.140）。有迹象表明，血管内首选策略的QIB更高，成本更低，合并后的INB为3877磅（95% CI 253磅，7408）磅或（原文如此）4356（95%CI（原文如此）284，（原文如此）8323）结论破裂动脉瘤的血管内首选治疗策略不能提供超过1年的生存获益，但可以使患者更快地出院时生活质量更好，具有成本效益。
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 pound (95% CI 253 pound, 7408) pound or (sic)4356 (95% CI (sic)284, (sic)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.