Deery Sarah E, Shean Katie E, Pothof Alexander B, O'Donnell Thomas F X, Dalebout Barbara A, Darling Jeremy D, Bodewes Thomas C F, Schermerhorn Marc L
Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA.
Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA.
Ann Vasc Surg. 2018 Jul;50:202-208. doi: 10.1016/j.avsg.2017.12.017. Epub 2018 Mar 2.
Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system.
From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was abdominal aortic aneurysm (AAA)-related mortality, and secondary end points were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used for late outcomes.
A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality rate was 1.1%, with 2 deceased patients in the perioperative period. All-cause mortality rate at 3 years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair through 3 years of follow-up. Only 11 patients (6.2%) had undergone reintervention at 3 years. Younger age was associated with reintervention (HR 3.3 per younger decade, 95% confidence interval 1.3-7.6, P < 0.01), but neck diameter, length, and angulation were not significantly associated with reintervention.
The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 1 in 16 patients underwent reintervention by 3 years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, despite more liberal "Instructions For Use" parameters, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.
血管内动脉瘤修复术（EVAR）的长期数据是存在的，但仅限于已不再使用的血管内移植物。ENGAGE批准后研究的目的是描述使用Endurant支架移植物系统进行EVAR后的长期安全性和有效性数据。
2011年8月至2012年6月，178例患者入组并接受Endurant支架移植物系统治疗。前瞻性收集并分析临床和放射学数据。主要终点是腹主动脉瘤（AAA）相关死亡率，次要终点是全因死亡率、内漏、二次干预和器械相关并发症。采用Kaplan-Meier估计法评估远期结局。
共有178例患者在24个中心接受了Endurant支架移植物的EVAR治疗（82%为男性；中位年龄71岁，四分位间距[IQR]66 - 79岁）。主动脉中位直径为55 mm（IQR 51 - 58 mm）。技术成功率为98.9%。分别有87%和74%的患者获得了3年的临床和影像学随访数据。中位随访时间为37个月（IQR 30 - 38个月）。3年的动脉瘤相关死亡率为1.1%，围手术期有2例患者死亡。3年全因死亡率为13%。在3年的随访中，无患者发生动脉瘤破裂或转为开放修复手术。3年时仅有11例患者（6.2%）接受了再次干预。年轻与再次干预相关（每年轻十岁的风险比为3.3，95%置信区间1.3 - 7.6，P < 0.01），但颈部直径、长度和角度与再次干预无显著相关性。
Endurant支架移植物系统为治疗肾下腹主动脉瘤提供了一种安全、持久的方法。无患者发生晚期破裂或动脉瘤相关死亡，到3年时每16例患者中仅有1例接受了再次干预。尽管Endurant移植物的“使用说明”参数更为宽松，但其再次干预率似乎低于其他当代移植物，但仍需要包括直接移植物比较在内的进一步研究来指导合适的移植物选择。
