肾周动脉瘤腔内修复术与开放手术修复的临床疗效和每质量调整生命年的成本比较。

Clinical efficacy and cost per quality-adjusted life years of pararenal endovascular aortic aneurysm repair compared with open surgical repair.

机构信息

Western Vascular Institute, Department of Vascular and Endovascular Surgery, University College Hospital Galway, Newcastle Road, Galway, Ireland.

出版信息

J Endovasc Ther. 2011 Apr;18(2):181-96. doi: 10.1583/10-3072.1.

DOI:10.1583/10-3072.1

PMID:21521058

Abstract

PURPOSE

To gauge the efficacy of applying commercially-available endografts to pararenal endovascular abdominal aortic aneurysm (AAA) repair compared with open surgical repair (OSR).

METHODS

From 2001 to 2009, 1868 AAA patients were referred to our service for evaluation; of these, 118 patients had pararenal AAAs. Sixty-six patients (51 men; mean age 70.8±7.6 years) had OSR and 52 (44 men; mean age 74.3±7.2 years) underwent pararenal endovascular aneurysm repair (EVAR). The pararenal EVAR patients were older (74.3 versus 70.8 years, p = 0.014), with higher mean comorbidity severity scores (p = 0.0001). Mean aneurysm diameter was larger in the OSR patients (6.6 versus 5.9 cm, p = 0.01). Primary endpoints were aneurysm-related survival and cost per quality-adjusted life years (QALY). Secondary endpoints included 3-year freedom from major adverse clinical events, all-cause mortality, and secondary intervention.

RESULTS

There was no perioperative mortality in the pararenal EVAR group versus 3 (4.5%) deaths among the OSR patients (p = 0.122). The 15% 30-day morbidity with pararenal EVAR was half that of OSR (p = 0.059). Mean follow-up was 28.8 ±21.6 months for pararenal EVAR and 35.7±23.2 months for OSR. There were no aneurysm ruptures in either group and no conversions to open repair in the pararenal EVAR group. Three-year aneurysm-related survival was significantly higher with pararenal EVAR (100%) versus OSR (92.4%, p = 0.045), but the freedom from any-cause death was lower with pararenal EVAR (57.1%) than OSR (84.8%, p = 0.195). Three-year freedom from secondary intervention (pararenal EVAR 83.4% versus OSR 95.5%, p = 0.301) and all-cause survival (pararenal EVAR 57.1% versus OSR 84.8%, p = 0.195) were similar. Over a 3-year period, pararenal EVAR costs (including follow-up and reintervention) averaged €20,375 per patient to give a QALY value of 0.90, while mean costs for OSR were €23,928 per patient (0.86 QALY). The incremental cost-effectiveness ratio for pararenal EVAR was €129,586 saved per QALY gained.

CONCLUSION

Pararenal EVAR afforded patients longer quality-adjusted time without symptoms or toxicity and superior freedom from major adverse events up to 3 years. Although the relatively low 3-year survival rate reflected the greater comorbidity of the EVAR patients, pararenal EVAR was cost-effective.

摘要

目的

评估使用市售内脏支架治疗肾周腹主动脉瘤（AAA）与开放手术修复（OSR）的疗效。

方法

2001 年至 2009 年，1868 例 AAA 患者到我院就诊；其中 118 例为肾周 AAA。66 例患者（51 例男性；平均年龄 70.8±7.6 岁）接受 OSR，52 例（44 例男性；平均年龄 74.3±7.2 岁）接受肾周腔内动脉瘤修复（EVAR）。肾周 EVAR 患者年龄较大（74.3 岁比 70.8 岁，p=0.014），平均合并症严重程度评分较高（p=0.0001）。OSR 患者的平均动脉瘤直径较大（6.6 厘米比 5.9 厘米，p=0.01）。主要终点为动脉瘤相关生存率和每质量调整生命年的成本（QALY）。次要终点包括 3 年无重大不良临床事件、全因死亡率和二次干预的自由。

结果

肾周 EVAR 组无围手术期死亡，而 OSR 组有 3 例（4.5%）死亡（p=0.122）。肾周 EVAR 的 15%的 30 天发病率是 OSR 的一半（p=0.059）。肾周 EVAR 的平均随访时间为 28.8±21.6 个月，OSR 为 35.7±23.2 个月。两组均无动脉瘤破裂，肾周 EVAR 组无中转开放修复。肾周 EVAR 的 3 年动脉瘤相关生存率显著高于 OSR（100%比 92.4%，p=0.045），但肾周 EVAR 的全因死亡率较低（57.1%比 84.8%，p=0.195）。肾周 EVAR 的 3 年无二次干预（83.4%比 OSR 的 95.5%，p=0.301）和全因生存率（57.1%比 OSR 的 84.8%，p=0.195）相似。在 3 年期间，肾周 EVAR 的成本（包括随访和再次介入）平均为每位患者 20375 欧元，获得 0.90 的 QALY 值，而 OSR 的每位患者的平均成本为 23928 欧元（0.86 的 QALY）。肾周 EVAR 的增量成本效益比为每获得一个 QALY 节省 129586 欧元。