Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms
Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms
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DOI：
10.1056/nejmoa051255
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发表时间：
2005-06-09
影响因子：
158.5
通讯作者：
Grobbee, DE
中科院分区：
文献类型：
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作者：
Blankensteijn, JD;de Jong, SECA;Grobbee, DE
背景：两项随机试验显示，术后第一个月，选择性腹主动脉瘤腔内修复术的效果优于传统的开放式修复术。我们调查了这种优势在围手术期后是否持续。方法：我们进行了一项多中心、随机试验，比较了351例被诊断为腹主动脉瘤直径至少为5cm且被认为适合两种技术的患者的开放式修复和血管内修复。随机化后的生存率使用Kaplan-Meier分析计算，并与使用log-rank检验在意向治疗基础上进行比较。结果：随机分组两年后，开放修复组的累积生存率为89.6%，血管内修复组的累积生存率为89.7%（差异为-0.1个百分点；95%置信区间为-6.8至6.7个百分点）。动脉瘤相关的累积死亡率，开放修复组为5.7%，血管内修复组为2.1%（差异，3.7个百分点；95%置信区间，-0.5到7.9个百分点）。血管内修复相对于开放修复的优势完全可以通过围手术期发生的事件来解释，在随后的动脉瘤相关死亡率方面没有显著差异。两组在两年内无中度或重度并发症的生存率也相似（开放修复为65.9%，血管内修复为65.6%；差异为0.3个百分点；95%置信区间为-10.0至10.6个百分点）。结论：血管内修复术与开放修复术相比，围手术期生存优势在术后一年后并未持续。
BACKGROUND:Two randomized trials have shown better outcomes with elective endovascular repair of abdominal aortic aneurysms than with conventional open repair in the first month after the procedure. We investigated whether this advantage is sustained beyond the perioperative period.METHODS:We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 351 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. Survival after randomization was calculated with the use of Kaplan-Meier analysis and compared with the use of the log-rank test on an intention-to-treat-basis.RESULTS:Two years after randomization, the cumulative survival rates were 89.6 percent for open repair and 89.7 percent for endovascular repair (difference, -0.1 percentage point; 95 percent confidence interval, -6.8 to 6.7 percentage points). The cumulative rates of aneurysm-related death were 5.7 percent for open repair and 2.1 percent for endovascular repair (difference, 3.7 percentage points; 95 percent confidence interval, -0.5 to 7.9 percentage points). This advantage of endovascular repair over open repair was entirely accounted for by events occurring in the perioperative period, with no significant difference in subsequent aneurysm-related mortality. The rate of survival free of moderate or severe complications was also similar in the two groups at two years (at 65.9 percent for open repair and 65.6 percent for endovascular repair; difference, 0.3 percentage point; 95 percent confidence interval, -10.0 to 10.6 percentage points).CONCLUSIONS:The perioperative survival advantage with endovascular repair as compared with open repair is not sustained after the first postoperative year.