Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 主要终点
- Overall mortality
研究概览
简要总结
The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.
详细描述
This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).
Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •juxtarenal abdominal aortic aneurysms
- •pararenal abdominal aortic aneurysms
- •suprarenal abdominal aortic aneurysms
- •type IV thoracoabdominal aneurysms
排除标准
- •extent I to III thoracoabdominal aneurysms
- •ruptured o symptomatic aneurysms
- •dissections or connective tissue disorder aneurysms.
结局指标
主要结局
Overall mortality
时间窗: Through study completion, an average of 5 year
All cause death
Aortic-related mortality
时间窗: Through study completion, an average of 5 year
Any death related to the initial procedure.
Chronic renal decline during follow-up
时间窗: Through study completion, an average of 5 year
Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to \<60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of \>20% or de novo dependence on permanent renal replacement therapy.
次要结局
- Aortic-related reintervention(Through study completion, an average of 5 year)
- Clinical failure(Through study completion, an average of 5 year)
- Target vessel occlusion(Through study completion, an average of 5 year)
- Proximal aorta degeneration Proximal aorta degeneration(Through study completion, an average of 5 year)
研究者
TINELLI GIOVANNI
Head of the Endovascular Therapies Unit
Fondazione Policlinico Universitario Agostino Gemelli IRCCS