Division of Vascular Surgery, UPMC Hospitals, Pittsburgh, PA 15213, USA.
J Vasc Surg. 2011 Sep;54(3):601-8. doi: 10.1016/j.jvs.2011.03.002.
To report the 1-year outcomes of the United States (US) regulatory trial of the Endurant Stent Graft System (Medtronic Vascular), a new device for the treatment of abdominal aortic aneurysms (AAA).
This was a prospective, single arm, multicenter trial conducted at 26 sites in the US. From April 2008 to May 2009, 150 patients with AAA were treated with the Endurant bifurcated stent graft. The main inclusion criteria were an AAA diameter >5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60 degrees. A clinical events committee (CEC) adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging. The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months.
One hundred forty-nine patients (99.3%) had a successful stent graft implant, 83.3% under general anesthesia. One failure was due to inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years) with significant comorbidities. Mean estimated blood loss was 185 mL (range, 0-1450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. At 1 month, the major adverse events rate was only 4% with no operative mortality. Serious adverse events were recorded in 43 of 150 (28.7%) patients. Cardiac (8.7%), fever (6%), urological (4.7%), pulmonary (4%), and vascular events (4%) were the most frequent. Through 12 months of follow up, there were no migrations, ruptures, or conversions. No type I or III endoleaks were identified during the first year. Fifteen of 129 patients (11.6%) had endoleaks at 6 months and 13 of 130 (10%) at 1 year, all type II except for one indeterminate endoleak. One Type II endoleak proved to be a Type IB on later angiography. Ten aneurysm related reinterventions were performed during the first year of follow up, mostly for limb thrombosis or stenosis (5) or for type II endoleak (2). Four of the procedures were endovascular. Aneurysm sac diameter decreased >5 mm at 1 year in 47% of patients and remained stable in 53%. No sac showed an increase of >5 mm. None of seven late deaths (range, 90-458 days post-implant) was adjudicated to be aneurysm related.
Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.
报告美国监管机构对 Endurant 支架移植物系统（美敦力血管）的临床试验结果，该系统是一种用于治疗腹主动脉瘤（AAA）的新型装置。
这是一项在美国 26 个地点进行的前瞻性、单臂、多中心试验。2008 年 4 月至 2009 年 5 月，150 例 AAA 患者接受了 Endurant 分叉支架移植物治疗。主要纳入标准为 AAA 直径>5cm，近端颈部长度≥10mm，双侧髂固定长度≥15mm，颈部成角≤60 度。临床事件委员会（CEC）裁定所有不良事件（除失血外），核心实验室审查所有影像学结果。主要安全性终点为 30 天无重大不良事件，主要有效性终点为 12 个月时成功治疗动脉瘤。
149 例患者（99.3%）支架移植物植入成功，83.3%患者采用全身麻醉。1 例失败的原因是无法对侧门进行插管。1 例患者在手术过程中发生颈部破裂，但仍成功治疗。患者主要为男性（91.3%），年龄较大（平均年龄 73.1 岁），合并多种严重疾病。平均估计失血量为 185ml（范围 0-1450ml），1 例患者需要输血。平均住院时间为 2.1 天。1 个月时，主要不良事件发生率仅为 4%，无手术死亡。150 例患者中有 43 例（28.7%）发生严重不良事件。心脏（8.7%）、发热（6%）、泌尿系统（4.7%）、肺部（4%）和血管事件（4%）是最常见的。随访 12 个月，无移位、破裂或转换。第一年未发现 I 型或 III 型内漏。129 例患者中有 15 例（11.6%）在 6 个月时和 130 例患者中有 13 例（10%）在 1 年时出现内漏，均为 II 型，除 1 例不确定内漏外，无 III 型内漏。1 例 IIB 型内漏后来证实为 IIA 型。在第一年的随访中有 10 例与动脉瘤相关的再介入治疗，主要是为了治疗肢体血栓或狭窄（5 例）或 II 型内漏（2 例）。其中 4 例为血管内治疗。47%的患者在 1 年内动脉瘤囊直径缩小>5mm，53%的患者保持稳定。没有一个动脉瘤的囊直径增加>5mm。7 例晚期死亡（植入后 90-458 天）中无一例被裁定与动脉瘤相关。
Endurant 关键试验的早期结果令人鼓舞，提示这是一种用于治疗腹主动脉瘤的安全有效的新型装置。
