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Lancet:腔内动脉瘤修补术的长期生存获益逊色于开放性修补术

2016-10-13 MedSci MedSci原创

本研究旨在调查腔内动脉瘤修补术(EVAR)与开放性修复术相比,是否具有长期生存益处。 分析数据来自EVAR试验1,涉及1252名患者,来自英国37个中心。患者的年龄≥60岁、动脉瘤直径≥5.5厘米,适合EVAR或开放性修复。按1:1随机分到两种治疗方式组,各有626例患者。对ITT人群进行了分析,主要结果是总的和动脉瘤相关的死亡。 研究者的纳入时间为1999月9月1日至2004年8月3

本研究旨在调查腔内动脉瘤修补术(EVAR)与开放性修复术相比,是否具有长期生存益处。

分析数据来自EVAR试验1,涉及1252名患者,来自英国37个中心。患者的年龄≥60岁、动脉瘤直径≥5.5厘米,适合EVAR或开放性修复。按1:1随机分到两种治疗方式组,各有626例患者。对ITT人群进行了分析,主要结果是总的和动脉瘤相关的死亡。

研究者的纳入时间为1999月9月1日至2004年8月31日,有25例患者在2015年6月30日之后失去了随访,其中4例是因为死亡。

平均超过12·7年(SD 1·5;最大15·8年)的随访中,EVAR和开放性修复组的死亡率分别为9·3/100人年和8·9/100人年(aHR 1·11, 95% CI 0·97–1·27, p=0·14)。

随机化后0-6个月,EVAR组患者的死亡率更低(总死亡率 aHR 0·61, 95% CI 0·37–1·02;动脉瘤相关死亡率 aHR 0·47, 0·23–0·93, p=0·031);但是在随访8个月以上,我们却发现开放性修复患者的死亡率更低(总死亡率 aHR 1·25, 95% CI 1·00–1·56, p=0·048;动脉瘤相关死亡率 aHR 5·82, 1·64–20·65, p=0·0064)。

随访8个月以后,EVAR组患者的动脉瘤相关死亡率增加,究其原因,主要是动脉瘤破裂(EVAR和开放性修复组分别为13例[7%]死亡和2例[1%]死亡);此外,EVAR组患者的癌症死亡率也增加。

结果表明,与开放性修复组患者相比,EVAR只能给患者带来短期生存获益,长期以往,反而会降低患者的生存获益。

原始出处:

Rajesh Patel,et al.Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial.Lancet.October 12, 2016

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