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腹腔大动脉动脉瘤的内血管和开放修复后的结果:一个随机试验

Frank A Lederle¹, Julie A Freischlag, Tassos C Kyriakides

¹Medicine Service, Veterans Affairs Medical Center, Minneapolis, Minnesota 55417, USA. frank.lederle@va.gov

|October 15, 2009

概括

腹腔大动脉动脉瘤 (AAA) 的内血管修复显示,术后死亡率低于开放修复,长期结果长达两年. 关于AAA治疗的最终结论需要进一步的数据.

科学领域:

血管外科血管外科
医疗干预医疗干预
临床试验临床试验

背景情况:

关于内血管修复对腹腔大动脉瘤 (AAA) 开放修复的短期益处的数据有限.
开始了一项随机临床试验,以比较这两种AAA修复方法.

研究的目的:

为了比较AAA的内血管或开放修复后长达两年的术后结果.
为了提供一个计划为期九年的试验的临时报告.

主要方法:

一个随机的多中心临床试验,涉及881名符合AAA条件的退伍军人.
参与者接受了选择性内血管修复 (n=444) 或开放修复 (n=437).
评估的结果包括程序失败,次要程序,停留时间,生活质量,勃起功能障碍,发病率和死亡率.

主要成果:

术后死亡率在内血管修复 (0.5%) 与开放修复 (3.0%) 相比显著较低.
血管内修复组经历了手术时间的缩短,血液损失,输血需求,通风持续时间和住院/ICU的停留时间.
两年后在主要发病率,手术失败,次要手术,动脉瘤相关住院治疗,生活质量或勃起功能方面没有发现显著差异.

结论:

血管内修复显示,与开放修复相比,AAA的术后死亡率较低.
血管内修复的早期优势并没有被在前两年内增加的发病率或死亡率所否定.
需要长期的随访,以充分评估内血管和开放AAA修复的比较有效性.

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