Sicard Gregorio A, Zwolak Robert M, Sidawy Anton N, White Rodney A, Siami Flora S
Department of Surgery, Division of General Surgery and Section of Vascular Surgery, Washington University School of Medicine, St. Louis, MO, USA.
J Vasc Surg. 2006 Aug;44(2):229-36. doi: 10.1016/j.jvs.2006.04.034. Epub 2006 Apr 27.
The study was conducted to determine the outcome in the United States after endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at high-risk for open surgery by using independently audited, high-compliance, chart-verified data sets, and to compare those results with open surgery.
High-risk was defined to match a recent European trial (EVAR2) and included age of > or =60 years with aneurysm size of > or =5.5 cm, plus at least one cardiac, pulmonary, or renal comorbidity. Data from five multicenter investigational device exemption clinical trials leading to Food and Drug Administration (FDA) approval were analyzed. Of 2216 EVAR patients, 565 met the high-risk criteria. Of 342 surgical controls (OPEN), 61 met high-risk criteria. Primary outcome comparisons included AAA-related death, all-cause death, and aneurysm rupture. Secondary measures were endoleak, AAA sac enlargement, and migration.
Average age of the high-risk EVAR subset was 76 +/- 7 years vs 74 +/- 6 years OPEN (P = 0.07), mean EVAR AAA size was 6.4 +/- 0.8 cm vs 6.6 +/- 1.0 cm OPEN (P = .33), and average EVAR follow-up was 2.7 years vs 2.5 years OPEN. The 30-day operative mortality was 2.9% in EVAR vs 5.1% in OPEN (P = .32). The AAA-related death rate after EVAR was 3.0% at 1 year and 4.2% at 4 years compared with 5.1% at both time points after OPEN (P = .58). Overall survival at 4 years after EVAR was 56% vs 66% in OPEN (P = .23). After treatment, EVAR successfully prevented rupture in 99.5% at 1 year and in 97.2% at 4 years.
Endovascular repair of large infrarenal AAAs in anatomically suited high-surgical-risk patients using FDA-approved devices in the United States is safe and provides lasting protection from AAA-related mortality. EVAR mortality remained comparable with OPEN up to 4 years. The decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered, but repair provides excellent protection from AAA-related death.
本研究旨在利用独立审核、高合规性、经图表验证的数据集，确定美国采用血管腔内修复术（EVAR）治疗肾下腹主动脉瘤（AAA）的高危患者的治疗结果，并将这些结果与开放手术的结果进行比较。
将高危定义为符合近期一项欧洲试验（EVAR2）的标准，包括年龄≥60岁且动脉瘤大小≥5.5 cm，以及至少合并一种心脏、肺部或肾脏疾病。对五项导致美国食品药品监督管理局（FDA）批准的多中心研究性器械豁免临床试验的数据进行了分析。在2216例接受EVAR治疗的患者中，565例符合高危标准。在342例手术对照组（OPEN）中，61例符合高危标准。主要结局比较包括与AAA相关的死亡、全因死亡和动脉瘤破裂。次要指标为内漏、AAA瘤体增大和移位。
高危EVAR亚组的平均年龄为76±7岁，而开放手术组为74±6岁（P = 0.07）；EVAR组的平均AAA大小为6.4±0.8 cm，开放手术组为6.6±1.0 cm（P = 0.33）；EVAR组的平均随访时间为2.7年，开放手术组为2.5年。EVAR组的30天手术死亡率为2.9%，开放手术组为5.1%（P = 0.32）。EVAR术后1年与AAA相关的死亡率为3.0%，4年时为4.2%，而开放手术组在这两个时间点均为5.1%（P = 0.58）。EVAR术后4年的总生存率为56%，开放手术组为66%（P = 0.23）。治疗后，EVAR在1年时成功预防破裂的比例为99.5%，4年时为97.2%。
在美国，使用FDA批准的器械对解剖结构适合的高手术风险患者进行肾下大型AAA的血管腔内修复是安全的，并能长期预防与AAA相关的死亡。EVAR的死亡率在4年内与开放手术相当。对于老年和有严重合并症的患者，治疗AAA的决定必须个体化并仔细考虑，但修复可有效预防与AAA相关的死亡。
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