Endovascular Repair of Aortic Aneurysm in Patients Physically Ineligible for Open Repair
Endovascular Repair of Aortic Aneurysm in Patients Physically Ineligible for Open Repair
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DOI：
10.1056/nejmoa0911056
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发表时间：
2010-05-20
影响因子：
158.5
通讯作者：
Epstein, David
中科院分区：
文献类型：
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作者：
Greenhalgh, Roger M.;Brown, Louise C.;Epstein, David
背景腹主动脉瘤的血管内修复术最初是为那些被认为身体不适合开放手术修复的患者开发的。关于血管内修复是否会降低这些患者的死亡率这一问题，目前还缺乏数据。 方法 从 1999 年到 2004 年，我们在英国 33 家医院随机分配了 404 名被认为不适合进行开放式修复的大型腹主动脉瘤（直径 >= 5.5 厘米）患者接受血管内修复或不进行修复； 197 名患者被分配接受血管内修复，207 名患者被分配不接受干预。随访患者的死亡率、移植物相关并发症、再次干预以及费用直至 2009 年底。使用 Cox 回归比较两组的结果。结果血管内修复组的 30 天手术死亡率为 7.3%。未干预组的动脉瘤破裂总体率为每 100 人年 12.4 例（95% 置信区间 [CI]，9.6 至 16.2）。血管内修复组的动脉瘤相关死亡率较低（调整后的风险比为0.53；95% CI，0.32至0.89；P=0.02）。这一优势并未给总死亡率带来任何益处（调整后的风险比，0.99；95% CI，0.78 至 1.27；P=0.97）。血管内修复术后幸存的患者中，共有 48% 出现移植物相关并发症，27% 的患者在头 6 年内需要再次干预。在 8 年的随访期间，血管内修复比不进行修复要贵得多（成本差异为 9,826 磅 [14,867 美元]；95% CI，7,638 至 12,013 [11,556 至 18,176]）。 结论 在这项涉及身体不适合开放修复的患者的随机试验中，腹主动脉血管内修复与不进行修复相比，动脉瘤与动脉瘤相关的死亡率显着降低。然而，血管内修复与任何原因死亡率的降低无关。血管内修复术的移植物相关并发症和再次干预发生率更高，而且成本更高。 （当前对照试验编号，ISRCTN55703451。）
BACKGROUNDEndovascular repair of abdominal aortic aneurysm was originally developed for patients who were considered to be physically ineligible for open surgical repair. Data are lacking on the question of whether endovascular repair reduces the rate of death among these patients.METHODSFrom 1999 through 2004 at 33 hospitals in the United Kingdom, we randomly assigned 404 patients with large abdominal aortic aneurysms (>= 5.5 cm in diameter) who were considered to be physically ineligible for open repair to undergo either endovascular repair or no repair; 197 patients were assigned to undergo endovascular repair, and 207 were assigned to have no intervention. Patients were followed for rates of death, graft-related complications and reinterventions, and costs until the end of 2009. Cox regression was used to compare outcomes in the two groups.RESULTSThe 30-day operative mortality was 7.3% in the endovascular-repair group. The overall rate of aneurysm rupture in the no-intervention group was 12.4 (95% confidence interval [CI], 9.6 to 16.2) per 100 person-years. Aneurysm-related mortality was lower in the endovascular-repair group (adjusted hazard ratio, 0.53; 95% CI, 0.32 to 0.89; P=0.02). This advantage did not result in any benefit in terms of total mortality (adjusted hazard ratio, 0.99; 95% CI, 0.78 to 1.27; P=0.97). A total of 48% of patients who survived endovascular repair had graft-related complications, and 27% required reintervention within the first 6 years. During 8 years of follow-up, endovascular repair was considerably more expensive than no repair (cost difference, 9,826 pound [U. S. $14,867]; 95% CI, 7,638 to 12,013 [11,556 to 18,176]).CONCLUSIONSIn this randomized trial involving patients who were physically ineligible for open repair, endovascular repair of abdominal aortic aneurysm was associated with a significantly lower rate of aneurysm-related mortality than no repair. However, endovascular repair was not associated with a reduction in the rate of death from any cause. The rates of graft-related complications and reinterventions were higher with endovascular repair, and it was more costly. (Current Controlled Trials number, ISRCTN55703451.)