Institute for Health Care Research and Improvement, Baylor Health Care System, Dallas, TX 76206, USA.
Mayo Clin Proc. 2013 Sep;88(9):910-9. doi: 10.1016/j.mayocp.2013.05.014.
To assess whether survival differences exist between patients undergoing immediate open repair vs surveillance with selective repair for 4.0- to 5.4-cm abdominal aortic aneurysms (AAAs) and whether these differences vary by diameter, within sexes, or overall.
The study cohort included 2226 patients randomized to immediate repair or surveillance for the UK Small Aneurysm Trial (September 1, 1991, through July 31, 1998; follow-up, 2.6-6.9 years) or the Aneurysm Detection and Management trial (August 1, 1992, through July 31, 2000; follow-up, 3.5-8.0 years). Survival differences were assessed with proportional hazard models, adjusted for a comprehensive array of clinical and nonclinical risk factors. Interaction between treatment and AAA size was added to the model to assess whether the effect of immediate open repair vs surveillance varied by AAA size.
The adjusted analysis revealed no statistically significant survival difference between immediate open repair and surveillance patients (hazard ratio [HR], 0.99; 95% CI, 0.83-1.18; mean follow-up time, 1921 days for both study groups). This lack of treatment effect persisted when men (HR, 1.01; 95% CI, 0.84-1.21) and women (HR, 0.96; 95% CI, 0.49-1.86) were examined separately and did not vary by AAA size (P=.39 for the entire cohort and P=.24 for women).
Immediate open repair offered no significant survival benefit, even in patients with the largest AAAs and highest risk of rupture. Because recent trials failed to find a survival benefit of immediate endovascular repair over surveillance for small asymptomatic AAAs, our findings suggest that the gray area of first-line management for these patients should be resolved in favor of surveillance.
评估对于 4.0-5.4cm 腹主动脉瘤(AAA)患者,行即刻开放修复与选择性修复加监测相比是否存在生存差异,以及这些差异是否因直径、性别或总体情况而异。
研究队列包括 2226 名患者,他们被随机分配至 UK Small Aneurysm Trial(1991 年 9 月 1 日至 1998 年 7 月 31 日;随访时间 2.6-6.9 年)或 Aneurysm Detection and Management trial(1992 年 8 月 1 日至 2000 年 7 月 31 日;随访时间 3.5-8.0 年)中进行即刻修复或监测。采用比例风险模型评估生存差异,模型调整了一系列临床和非临床风险因素。模型中加入了治疗与 AAA 大小的交互作用,以评估即刻开放修复与监测相比,治疗效果是否因 AAA 大小而异。
调整分析显示,即刻开放修复与监测患者之间的生存无统计学显著差异(风险比[HR],0.99;95%置信区间,0.83-1.18;两组平均随访时间均为 1921 天)。当分别检查男性(HR,1.01;95%置信区间,0.84-1.21)和女性(HR,0.96;95%置信区间,0.49-1.86)时,这种无治疗效果的情况仍然存在,并且 AAA 大小也无差异(整个队列中 P=.39,女性中 P=.24)。
即使对于 AAA 最大和破裂风险最高的患者,即刻开放修复也不能带来显著的生存获益。由于最近的试验未能发现即时血管内修复相对于小无症状 AAA 的监测具有生存优势,因此我们的研究结果表明,这些患者的一线治疗方法的灰色地带应倾向于监测。