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三项比较血管内修复与开放修复治疗破裂腹主动脉瘤的随机试验的个体患者荟萃分析。

Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm.

作者信息

Sweeting M J, Balm R, Desgranges P, Ulug P, Powell J T

机构信息

Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.

Department of Vascular Surgery, Academic Medical Centre, Amsterdam, The Netherlands.

出版信息

Br J Surg. 2015 Sep;102(10):1229-39. doi: 10.1002/bjs.9852. Epub 2015 Jun 24.

Abstract

BACKGROUND

The benefits of endovascular repair of ruptured abdominal aortic aneurysm remain controversial, without any strong evidence about advantages in specific subgroups.

METHODS

An individual-patient data meta-analysis of three recent randomized trials of endovascular versus open repair of abdominal aortic aneurysm was conducted according to a prespecified analysis plan, reporting on results to 90 days after the index event.

RESULTS

The trials included a total of 836 patients. The mortality rate across the three trials was 31.3 per cent for patients randomized to endovascular repair/strategy and 34.0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0.88, 95 per cent c.i. 0.66 to 1.18), and 34.3 and 38.0 per cent respectively at 90 days (pooled odds ratio 0.85, 0.64 to 1.13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8.2(1.9) cm and the overall in-hospital mortality rate was 34.8 per cent. There was no significant effect modification with age or Hardman index, but there was indication of an early benefit from an endovascular strategy for women. Discharge from the primary hospital was faster after endovascular repair (hazard ratio 1.24, 95 per cent c.i. 1.04 to 1.47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0.69 (95 per cent c.i. 0.53 to 0.89) per 15 mm), but aortic diameter was not associated with mortality for either type of repair.

CONCLUSION

Survival to 90 days following an endovascular or open repair strategy is similar for all patients and for the restricted population anatomically suitable for endovascular repair. Women may benefit more from an endovascular strategy than men and patients are, on average, discharged sooner after endovascular repair.

摘要

背景

腹主动脉瘤破裂的血管内修复的益处仍存在争议,尚无关于特定亚组优势的有力证据。

方法

根据预先指定的分析计划,对最近三项腹主动脉瘤血管内修复与开放修复的随机试验进行个体患者数据荟萃分析,报告指数事件后90天的结果。

结果

这些试验共纳入836例患者。在30天时,随机接受血管内修复/策略的患者的死亡率在三项试验中为31.3%,随机接受开放修复的患者为34.0%(合并比值比0.88,95%置信区间0.66至1.18),在90天时分别为34.3%和38.0%(合并比值比0.85,0.64至1.13)。试验间比值比无显著异质性证据。平均(标准差)动脉瘤直径为8.2(1.9)cm,总体住院死亡率为34.8%。年龄或哈德曼指数无显著效应修正,但有迹象表明血管内策略对女性有早期益处。血管内修复后从基层医院出院更快(风险比1.24,95%置信区间1.04至1.47)。对于开放修复,30天死亡率随动脉瘤颈部长度增加而降低(每增加15mm调整后的比值比0.69(95%置信区间0.53至0.89)),但两种修复类型的主动脉直径与死亡率均无关。

结论

对于所有患者以及解剖学上适合血管内修复的受限人群,血管内或开放修复策略后90天的生存率相似。女性可能比男性从血管内策略中获益更多,且血管内修复后患者平均出院更早。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50c1/4744980/f37a007b6129/BJS-102-1229-g002.jpg

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