A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients
A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients
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DOI：
10.1016/j.jvs.2010.10.124
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发表时间：
2011-05-01
影响因子：
4.3
通讯作者：
Marzelle, Jean
中科院分区：
文献类型：
--
作者：
Becquemin, Jean-Pierre;Pillet, Jean-Chistophe;Marzelle, Jean
背景资料：包括3项随机对照试验（RCT）在内的多项研究表明，腹主动脉瘤（AAA）的腔内修复术（EVAR）提供了比开放手术修复术（OSR）更好的早期结果，但中长期死亡率相似，再次介入的发生率更高。因此，腹主动脉瘤腔内修复术的作用，特别是在低风险patients.Methods：ACE（Anevrysme de l 'Ancharte abdominale：Chirurgie与Endoprothese）试验比较腹主动脉瘤腔内修复术和OSR后腹主动脉瘤患者的死亡率和主要不良事件，解剖适合腹主动脉瘤腔内修复术和开放手术的低风险或中等风险。共有316例动脉瘤>5 cm的患者被随机分配到具有两种治疗专业知识的机构：299例患者可用于分析，149例分配到OSR，150例分配到腹主动脉瘤腔内修复术。治疗后对患者进行5年的监测。统计学分析采用意向治疗。结果：中位随访时间为3年（范围，0-4.8年），OSR和腹主动脉瘤腔内修复术之间无死亡或重大事件的累积生存率无差异：1年时分别为95.9% +/- 1.6% vs 93.2% +/- 2.1%，3年时分别为85.1% +/- 4.5% vs 82.4% +/- 3.7%（P = .09）。住院死亡率（0.6% vs 1.3%; P = 1.0）、生存率和轻微并发症的百分比无统计学差异。然而，在腹主动脉瘤腔内修复术组中，再次介入的粗百分比较高（2.4% vs 16%，P <0.0001），腹主动脉瘤相关死亡率有较高的趋势（0.7% vs 4%; P = 0.12）。结论：在低至中等风险因素的患者中，AAA开放修复术与腹主动脉瘤腔内修复术一样安全，仍然是一种更持久的选择。（J Vase Surg 2011;53：1167-73。）
Background: Several studies, including three randomized controlled trials (RCTs), have shown that endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) offered better early results than open surgical repair (OSR) but a similar medium-term to long-term mortality and a higher incidence of reinterventions. Thus, the role of EVAR, most notably in low-risk patients, remains debated.Methods: The ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) trial compared mortality and major adverse events after EVAR and OSR in patients with AAA anatomically suitable for EVAR and at low-risk or intermediate-risk for open surgery. A total of 316 patients with >5 cm aneurysms were randomized in institutions with proven expertise for both treatments: 299 patients were available for analysis, and 149 were assigned to OSR and 150 to EVAR. Patients were monitored for 5 years after treatment. Statistical analysis was by intention to treat.Results: With a median follow-up of 3 years (range, 0-4.8 years), there was no difference in the cumulative survival free of death or major events rates between OSR and EVAR: 95.9% +/- 1.6% vs 93.2% +/- 2.1% at 1 year and 85.1% +/- 4.5% vs 82.4% +/- 3.7% at 3 years, respectively (P = .09). In-hospital mortality (0.6% vs 1.3%; P = 1.0), survival, and the percentage of minor complications were not statistically different. In the EVAR group, however, the crude percentage of reintervention was higher (2.4% vs 16%, P < .0001), with a trend toward a higher aneurysm-related mortality (0.7% vs 4%; P = .12).Conclusions: In patients with low to intermediate risk factors, open repair of AAA is as safe as EVAR and remains a more durable option. (J Vase Surg 2011;53:1167-73.)