Open versus Endovascular Repair of Abdominal Aortic Aneurysm
Open versus Endovascular Repair of Abdominal Aortic Aneurysm
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DOI：
10.1056/nejmoa1715955
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发表时间：
2019-05-30
影响因子：
158.5
通讯作者：
Johnson, Gary R.
中科院分区：
文献类型：
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作者：
Lederle, Frank A.;Kyriakides, Tassos C.;Johnson, Gary R.
选择性腹主动脉瘤血管内修复术的围手术期死亡率比传统的开放式修复术低，但4年后这种生存优势未见；此外，两项欧洲试验的结果显示，血管内修复术的长期预后比开放修复术差。我们十多年前进行的一项比较血管内修复和开放修复的研究的长期结果尚不清楚。方法将无症状腹主动脉瘤患者随机分为血管内修复组和开放式修复组。所有患者都是两种手术的候选人。对患者进行了长达14年的随访。结果881例患者随机分组，444例血管内修复组，437例血管内修复组。主要结局为全因死亡率。血管内修复组死亡302例（68.0%），开放修复组死亡306例（70.0%）（风险比0.96；95%可信区间[CI] 0.82 ~ 1.13）。在前4年的随访中，血管内修复术的总生存率似乎高于开放式修复术；从第4年到第8年，开放式修复组的总生存率更高；8年后，血管内修复组的总生存率再次更高（死亡风险比0.94;95% CI， 0.74至1.18）。这些趋势都不显著。血管内修复组有12例动脉瘤相关死亡（2.7%），开放修复组有16例（3.7%）（组间差异，-1.0个百分点；95% CI, -3.3 ~ 1.4）；多数死亡发生在围手术期。血管内修复组7例（1.6%）发生动脉瘤破裂，开放修复组1例（0.2%）发生胸动脉瘤破裂（组间差异为1.3个百分点，95% CI为0.1 ~ 2.6）。开放式修复组死于慢性阻塞性肺疾病的比例略高于50%（血管内修复组5.4%的患者死于慢性阻塞性肺疾病，开放式修复组8.2%的患者死于慢性阻塞性肺疾病；组间差异为-2.8个百分点；95% CI, -6.2至0.5）。血管内修复组更多的患者接受了二次手术。结论血管内修复组和开放修复组的长期总生存率相似。在接受二次治疗的患者数量上，两组之间存在差异。我们的结果与两项欧洲试验中关于血管内修复较差的长期生存表现的发现不一致。（由退伍军人事务部研究与发展办公室资助；OVER ClinicalTrials.gov号码，NCT00094575。）一项随机、多中心试验比较了血管内修复和腹主动脉瘤开放修复，结果显示这两种方法在8年后的总生存率没有显著差异。
BackgroundElective endovascular repair of an abdominal aortic aneurysm results in lower perioperative mortality than traditional open repair, but after 4 years this survival advantage is not seen; in addition, results of two European trials have shown worse long-term outcomes with endovascular repair than with open repair. Long-term results of a study we conducted more than a decade ago to compare endovascular repair with open repair are unknown.MethodsWe randomly assigned patients with asymptomatic abdominal aortic aneurysms to either endovascular repair or open repair of the aneurysm. All the patients were candidates for either procedure. Patients were followed for up to 14 years.ResultsA total of 881 patients underwent randomization: 444 were assigned to endovascular repair and 437 to open repair. The primary outcome was all-cause mortality. A total of 302 patients (68.0%) in the endovascular-repair group and 306 (70.0%) in the open-repair group died (hazard ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.13). During the first 4 years of follow-up, overall survival appeared to be higher with endovascular repair than with open repair; from year 4 through year 8, overall survival was higher in the open-repair group; and after 8 years, overall survival was once again higher in the endovascular-repair group (hazard ratio for death, 0.94; 95% CI, 0.74 to 1.18). None of these trends were significant. There were 12 aneurysm-related deaths (2.7%) in the endovascular-repair group and 16 (3.7%) in the open-repair group (between-group difference, -1.0 percentage point; 95% CI, -3.3 to 1.4); most deaths occurred during the perioperative period. Aneurysm rupture occurred in 7 patients (1.6%) in the endovascular-repair group, and rupture of a thoracic aneurysm occurred in 1 patient (0.2%) in the open-repair group (between-group difference, 1.3 percentage points; 95% CI, 0.1 to 2.6). Death from chronic obstructive lung disease was just over 50% more common with open repair (5.4% of patients in the endovascular-repair group and 8.2% in the open-repair group died from chronic obstructive lung disease; between-group difference, -2.8 percentage points; 95% CI, -6.2 to 0.5). More patients in the endovascular-repair group underwent secondary procedures.ConclusionsLong-term overall survival was similar among patients who underwent endovascular repair and those who underwent open repair. A difference between groups was noted in the number of patients who underwent secondary therapeutic procedures. Our results were not consistent with the findings of worse performance of endovascular repair with respect to long-term survival that was seen in the two European trials. (Funded by the Department of Veteran Affairs Office of Research and Development; OVER ClinicalTrials.gov number, NCT00094575.)A randomized, multicenter trial that compared endovascular repair with open repair of abdominal aortic aneurysm showed no significant difference between these approaches in overall survival after 8 years.