编辑推荐——ECAR（破裂性主-髂动脉瘤的血管内治疗或手术治疗）：一项关于破裂性主-髂动脉瘤血管内修复与开放手术修复的法国随机对照试验。
Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms.
作者信息
Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre J-P, Alsac J M, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin J-P
机构信息
Vascular Surgery Unit, CHU Henri Mondor, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Creteil, France.
Radiology Unit, CHU Henri Mondor, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Creteil, France.
出版信息
Eur J Vasc Endovasc Surg. 2015 Sep;50(3):303-10. doi: 10.1016/j.ejvs.2015.03.028. Epub 2015 May 20.
OBJECTIVES/BACKGROUND: ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms (rAIA) eligible for treatment by either endovascular (EVAR) or open surgical repair (OSR). Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture.
METHODS
Randomization was done by week, synchronously in all centers. The primary end point was 30 day mortality. Secondary end points were post-operative morbidity, length of stay in the intensive care unit (ICU), amount of blood transfused (units) and 6 month mortality.
RESULTS
From January 2008 to January 2013, 107 patients (97 men, 10 women; median age 74.4 years) were enrolled in 14 centers: 56 (52.3%) in the EVAR group and 51 (47.7%) in the OSR group. The groups were similar in terms of age, sex, consciousness, systolic blood pressure, Hardman index, IGSII score, type of rupture, use of endoclamping balloon, and levels of troponin, creatinine, and hemoglobin. Delay to treatment was higher in the EVAR group (2.9 vs. 1.3 hours; p < .005). Mortality at 30 days and 1 year were not different between the groups (18% in the EVAR group vs. 24% in the OSR group at 30 days, and 30% vs. 35%, respectively, at 1 year). Total respiratory support time was lower in the EVAR group than in the OSR group (59.3 hours vs. 180.3 hours; p = .007), as were pulmonary complications (15.4% vs. 41.5%, respectively; p = .050), total blood transfusion (6.8 vs. 10.9, respectively; p = .020), and duration of ICU stay (7 days vs. 11.9 days, respectively; p = .010).
CONCLUSION
In this study, EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality. However, EVAR was associated with less severe complications and less consumption of hospital resources than OSR.
目的/背景：ECAR（法国主动脉-髂动脉破裂动脉瘤血管内或外科治疗研究）是一项前瞻性多中心随机对照试验，纳入连续的适合血管内修复（EVAR）或开放手术修复（OSR）的主动脉-髂动脉破裂动脉瘤（rAIA）患者。纳入标准为血流动力学稳定且计算机断层扫描显示主动脉-髂动脉破裂。
方法
按周进行随机分组，所有中心同步进行。主要终点为30天死亡率。次要终点为术后发病率、重症监护病房（ICU）住院时间、输血量（单位）和6个月死亡率。
结果
2008年1月至2013年1月，14个中心共纳入107例患者（97例男性，10例女性；中位年龄74.4岁）：EVAR组56例（52.3%），OSR组51例（47.7%）。两组在年龄、性别、意识、收缩压、Hardman指数、IGSII评分、破裂类型、血管内球囊阻断使用情况以及肌钙蛋白、肌酐和血红蛋白水平方面相似。EVAR组的治疗延迟时间更长（2.9小时对1.3小时；p <.005）。两组30天和1年死亡率无差异（30天时EVAR组为18%，OSR组为24%；1年时分别为30%和35%）。EVAR组的总呼吸支持时间低于OSR组（59.3小时对180.3小时；p =.007），肺部并发症发生率也较低（分别为15.4%对41.5%；p =.050），总输血量较少（分别为6.8单位对10.9单位；p =.020），ICU住院时间较短（分别为7天对11.9天；p =.010）。
结论
在本研究中，就30天和1年死亡率而言，EVAR与OSR相当。然而，与OSR相比，EVAR相关并发症较轻，医院资源消耗较少。
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