Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms

Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms
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DOI:
10.1016/j.jvs.2009.10.113
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发表时间:
2010-05-01
影响因子:
4.3
通讯作者:
Zarins, Christopher K.
Zarins, Christopher K.
中科院分区:
医学2区
文献类型:
--
作者:
Ouriel, Kenneth;Clair, Daniel G.;Zarins, Christopher K.

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背景资料:尽管大型腹主动脉瘤(AAA)的修复已被广泛接受,但随机临床试验未能证明与监测相比早期手术修复小型动脉瘤的益处。在大动脉瘤患者中,血管内修复术已被证明比开放手术修复术更安全,这促使对小动脉瘤患者进行早期血管内修复术与监测的随机试验。(13.3%的女性;平均年龄71.8岁),4 - 5 cm AAA,早期腔内修复术(366例患者)或超声监测(362例患者)。破裂或动脉瘤相关的死亡率和总死亡率在两组进行了比较,平均随访20 - 12个月。结果:在随机治疗的患者中,89%接受动脉瘤修复术。在随机接受监测的患者中,31%在研究过程中接受了动脉瘤修复术。在平均随访20 - 12个月(范围,0-41个月)后,每组发生15例死亡(4.1%)。早期腔内修复术后死亡率的未校正风险比(95%置信区间)为1.01(0.49-2.07,P= 0.98)。每组有2名患者发生动脉瘤破裂或动脉瘤相关死亡(0.6%)。早期腔内修复术的未调整风险比为0.99(0.14-7.06,P= 0.99)。结论:早期腔内修复术治疗和严格的监测与选择性动脉瘤治疗表明都似乎是小AAA患者的安全替代方案,保护患者免于破裂或动脉瘤相关死亡至少3年。(J Vase Surg 2010;51:1081-7.)
Background: Although repair of large abdominal aortic aneurysms (AAAs) is well accepted, randomized clinical trials have failed to demonstrate benefit for early surgical repair of small aneurysms compared with surveillance. Endovascular repair has been shown to be safer than open surgical repair in patients with large aneurysms, prompting a randomized trial of early endovascular repair vs surveillance in patients with small aneurysms.Methods: We randomly assigned 728 patients (13.3% women; mean age, 71 8 years) with 4 to 5 cm AAAs to early endovascular repair (366 patients) or ultrasound surveillance (362 patients). Rupture or aneurysm-related death and overall mortality in the two groups were compared during a mean follow-up of 20 12 months.Results: Among patients randomized to treatment, 89% underwent aneurysm repair. Among patients randomized to surveillance, 31% underwent aneurysm repair during the course of the study. After a mean follow-up of 20 12 months (range, 0-41 months), 15 deaths had occurred in each group (4.1%). The unadjusted hazard ratio (95% confidence interval) for mortality after early endovascular repair was 1.01 (0.49-2.07, P=.98). Aneurysm rupture or aneurysm-related death occurred in two patients in each group (0.6%). The unadjusted hazard ratio was 0.99 (0.14-7.06, P=.99) for early endovascular repair.Conclusions: Early treatment with endovascular repair and rigorous surveillance with selective aneurysm treatment as indicated both appear to be safe alternatives for patients with small AAAs, protecting the patient from rupture or aneurysm-related death for at least 3 years. (J Vase Surg 2010;51:1081-7.)