N Engl J Med. 2010 May 20;362(20):1863-71. doi: 10.1056/NEJMoa0909305. Epub 2010 Apr 11.
Few data are available on the long-term outcome of endovascular repair of abdominal aortic aneurysm as compared with open repair.
From 1999 through 2004 at 37 hospitals in the United Kingdom, we randomly assigned 1252 patients with large abdominal aortic aneurysms (> or = 5.5 cm in diameter) to undergo either endovascular or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups.
The 30-day operative mortality was 1.8% in the endovascular-repair group and 4.3% in the open-repair group (adjusted odds ratio for endovascular repair as compared with open repair, 0.39; 95% confidence interval [CI], 0.18 to 0.87; P=0.02). The endovascular-repair group had an early benefit with respect to aneurysm-related mortality, but the benefit was lost by the end of the study, at least partially because of fatal endograft ruptures (adjusted hazard ratio, 0.92; 95% CI, 0.57 to 1.49; P=0.73). By the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause (adjusted hazard ratio, 1.03; 95% CI, 0.86 to 1.23; P=0.72). The rates of graft-related complications and reinterventions were higher with endovascular repair, and new complications occurred up to 8 years after randomization, contributing to higher overall costs.
In this large, randomized trial, endovascular repair of abdominal aortic aneurysm was associated with a significantly lower operative mortality than open surgical repair. However, no differences were seen in total mortality or aneurysm-related mortality in the long term. Endovascular repair was associated with increased rates of graft-related complications and reinterventions and was more costly. (Current Controlled Trials number, ISRCTN55703451.)
与开放修复相比，关于血管内修复腹主动脉瘤的长期结果的数据很少。
1999 年至 2004 年，在英国的 37 家医院中，我们将 1252 名大腹主动脉瘤（直径>或= 5.5 厘米）患者随机分为血管内修复或开放修复组；每组 626 名患者。直到 2009 年底，对两组患者的死亡率、移植物相关并发症、再次干预和资源使用情况进行随访。使用逻辑回归和 Cox 回归比较两组的结果。
血管内修复组的 30 天手术死亡率为 1.8%，开放修复组为 4.3%（血管内修复与开放修复相比，调整后的优势比为 0.39；95%置信区间 [CI]，0.18 至 0.87；P=0.02）。血管内修复组在动脉瘤相关死亡率方面早期获益，但研究结束时获益丧失，部分原因是致命的移植物内破裂（调整后的危险比，0.92；95%CI，0.57 至 1.49；P=0.73）。随访结束时，两组任何原因导致的死亡率均无显著差异（调整后的危险比，1.03；95%CI，0.86 至 1.23；P=0.72）。血管内修复组的移植物相关并发症和再次干预率较高，且新并发症在随机分组后 8 年内发生，导致总体费用增加。
在这项大型随机试验中，血管内修复腹主动脉瘤的手术死亡率明显低于开放手术修复。然而，长期来看，总死亡率或动脉瘤相关死亡率没有差异。血管内修复与移植物相关并发症和再次干预的发生率增加有关，且费用更高。（当前对照试验编号，ISRCTN55703451。）
