Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm

Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm
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DOI:
10.1056/nejmoa1207481
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发表时间:
2012-11-22
影响因子:
158.5
通讯作者:
Swanson, Kathleen M.
Swanson, Kathleen M.
中科院分区:
医学1区
文献类型:
--
作者:
Lederle, Frank A.;Freischlag, Julie A.;Swanson, Kathleen M.

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背景:与传统的开放式修复术相比,腹主动脉瘤择期血管内修复术是否能降低长期发病率和死亡率尚不确定。方法:我们随机分配881例无症状腹主动脉瘤患者进行血管内修复(444例)或开放修复(437例),随访9年(平均5.2年)。患者从42家退伍军人事务医疗中心挑选,登记时年龄在49岁或以上。结果95%以上的患者完成了指定修复。对于全因死亡率的主要结局,每组发生146例死亡(血管内修复与开放式修复的风险比为0.97;95%可信区间[CI], 0.77至1.22;P = 0.81)。先前报道的血管内修复术围手术期死亡率的降低在2年(风险比,0.63;95% CI, 0.40至0.98;P = 0.04)和3年(风险比,0.72;95% CI, 0.51至1.00;P = 0.05)持续,但此后没有。血管内修复组有10例动脉瘤相关死亡(2.3%),而开放修复组有16例(3.7%)(P = 0.22)。血管内修复组有6例动脉瘤破裂,而开放修复组无一例动脉瘤破裂(P = 0.03)。年龄和治疗方式之间存在显著的相互作用(P = 0.006);在70岁以下的患者中,血管内修复组的生存率增加,但在70岁及以上的开放修复组中,生存率往往更好。结论血管修复术与开放修复术的远期生存率相近。血管内修复术的围手术期生存优势持续了数年,但修复后破裂仍然是一个问题。血管内修复增加了年轻患者的长期生存率,但没有增加老年患者的长期生存率,对老年患者来说,血管内修复可以获得更大的益处。(由退伍军人事务部研究与发展办公室资助;OVER ClinicalTrials.gov号码,NCT00094575。)
BackgroundWhether elective endovascular repair of abdominal aortic aneurysm reduces long-term morbidity and mortality, as compared with traditional open repair, remains uncertain.MethodsWe randomly assigned 881 patients with asymptomatic abdominal aortic aneurysms who were candidates for both procedures to either endovascular repair (444) or open repair (437) and followed them for up to 9 years (mean, 5.2). Patients were selected from 42 Veterans Affairs medical centers and were 49 years of age or older at the time of registration.ResultsMore than 95% of the patients underwent the assigned repair. For the primary outcome of all-cause mortality, 146 deaths occurred in each group (hazard ratio with endovascular repair versus open repair, 0.97; 95% confidence interval [CI], 0.77 to 1.22; P = 0.81). The previously reported reduction in perioperative mortality with endovascular repair was sustained at 2 years (hazard ratio, 0.63; 95% CI, 0.40 to 0.98; P = 0.04) and at 3 years (hazard ratio, 0.72; 95% CI, 0.51 to 1.00; P = 0.05) but not thereafter. There were 10 aneurysm-related deaths in the endovascular-repair group (2.3%) versus 16 in the open-repair group (3.7%) (P = 0.22). Six aneurysm ruptures were confirmed in the endovascular-repair group versus none in the open-repair group (P = 0.03). A significant interaction was observed between age and type of treatment (P = 0.006); survival was increased among patients under 70 years of age in the endovascular-repair group but tended to be better among those 70 years of age or older in the open-repair group.ConclusionsEndovascular repair and open repair resulted in similar long-term survival. The perioperative survival advantage with endovascular repair was sustained for several years, but rupture after repair remained a concern. Endovascular repair led to increased long-term survival among younger patients but not among older patients, for whom a greater benefit from the endovascular approach had been expected. (Funded by the Department of Veterans Affairs Office of Research and Development; OVER ClinicalTrials.gov number, NCT00094575.)