Division of Vascular Surgery, Department of Surgery, The Johns Hopkins Medical Institutions, Baltimore, Maryland.
Division of Vascular Surgery, Department of Surgery, The Johns Hopkins Medical Institutions, Baltimore, Maryland2Editor, JAMA Surgery.
JAMA Surg. 2014 Dec;149(12):1260-5. doi: 10.1001/jamasurg.2014.275.
Because of the restrictions applied to the conduct of randomized clinical trials, the risks reported in their comparison of open and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) may not be applicable to real-world vascular surgical practice. The magnitude of this deviation is indeterminate.
To compare 30-day mortality from the recent Open Vs Endovascular Repair (OVER) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and to assess temporal trends in perioperative mortality.
DESIGN, SETTING, AND PARTICIPANTS: We analyzed data from 21,115 patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January 1, 2005, and December 31, 2011, in the NSQIP database. We used χ2 and t tests to compare perioperative mortality between groups. Logistic regression was used to analyze perioperative mortality, adjusting for age, sex, race, and comorbidities. The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP.
Death within 30 days of surgery.
Perioperative mortality was 3.7% (95% CI, 3.2%-4.3%) after open repair and 1.3% (95% CI, 1.2%-1.5%) after EVAR. There was a 70% reduction in operative mortality after EVAR compared with open repair (adjusted odds ratio [aOR], 0.30; 95% CI, 0.25-0.38; P < .001). Mortality was significantly lower in men compared with women (aOR, 0.73; 95% CI, 0.57-0.92; P = .009). Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair (EVAR, 1.3% vs 0.2%; open, 3.7% vs 2.3%). There was an increase in the proportion of patients who received EVAR during the 7 years studied (65% in 2005 and 80% in 2011). There has been no significant decrease in perioperative mortality during these years (P > .05).
Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials. We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair. This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA. There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques, devices, and proficiency.
由于对随机临床试验的限制，在比较开放和血管内修复（EVAR）治疗腹主动脉瘤（AAA）时报告的风险可能不适用于真实世界的血管外科实践。这种偏差的程度尚不确定。
将最近的开放与血管内修复退伍军人事务合作试验（OVER）的 30 天死亡率与美国外科医师学会国家手术质量改进计划（NSQIP）的结果进行比较，并评估围手术期死亡率的时间趋势。
设计、设置和参与者：我们分析了 2005 年 1 月 1 日至 2011 年 12 月 31 日期间 NSQIP 数据库中接受择期 EVAR 或开放修复治疗无症状肾下 AAA 的 21115 名患者的数据。我们使用 χ2 和 t 检验比较两组之间的围手术期死亡率。使用逻辑回归分析调整年龄、性别、种族和合并症后围手术期死亡率。然后将 OVER 试验的结果与 NSQIP 获得的全国估计值进行比较。
术后 30 天内死亡。
开放修复的围手术期死亡率为 3.7%（95%CI，3.2%-4.3%），EVAR 为 1.3%（95%CI，1.2%-1.5%）。EVAR 后手术死亡率降低了 70%（调整优势比[aOR]，0.30；95%CI，0.25-0.38；P<0.001）。与女性相比，男性死亡率显著降低（aOR，0.73；95%CI，0.57-0.92；P=0.009）。NSQIP 队列中的 30 天死亡率高于 OVER 试验报告的 EVAR 和开放修复的死亡率（EVAR，1.3%比 0.2%；开放，3.7%比 2.3%）。在研究的 7 年中，接受 EVAR 的患者比例有所增加（2005 年为 65%，2011 年为 80%）。在此期间，围手术期死亡率没有显著下降（P>0.05）。
OVER 试验报告的围手术期死亡率明显低于随机临床试验限制之外的实践结果。我们将这种差异归因于 OVER 试验排除了被认为不适合开放修复的高危患者。这一发现支持对肾下 AAA 患者进行个体化风险评估和治疗选择的必要性。尽管技术、设备和熟练程度有所提高，但近年来 EVAR 后的围手术期死亡率并未发生变化。
