Comparison of Endovascular and Open Repair of Juxta- and Pararenal Abdominal Aortic Aneurysm on Short- and Long-term Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 925
- 试验地点
- 1
- 主要终点
- All-cause Mortality
研究概览
简要总结
Background: Open repair remains the gold standard for fit patients with complex AAA. In the past decade, an evolution of devices, design, components, and delivery systems expanded the application of EVAR in these challenging anatomies. Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe. Initial reports have demonstrated a high technical success rate, low renal dysfunction rate, and low morbidity and mortality, with promising short- and long-term results. Other reports have shown excessive morbidity and mortality with fenestrated EVAR (FEVAR). Studies comparing endovascular and open repair are sparse, especially when it concerns long-term outcomes. There are till nowadays only two propensity score-matched studies, one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR (F/BEVAR) over open surgical repair (OSR).
Aim: The aim of this study will be to compare F/BEVAR versus open AAA repair on short- and long-term clinical outcomes for the treatment of juxta- and pararenal AAA.
Methodology: This is a prospective cohort study from the four high-volume AAA repair centers: Belgrade/Serbia, Bologna/Italy, Milan/Italy, Dijklander/Netherland, Amsterdam/Netherland, and Helsinki/Finland. Data will be collected on demographics, baseline comorbidities, AAA parameters (diameter and localization), laboratory values, intra-, and postoperative data. Follow-up examinations (clinical visits and color duplex ultrasonography, CT scans) will be performed 1, 6, and 12 months after the intervention, and annually thereafter. Propensity score analysis will be performed by matching open repair patients to endovascularly treated controlling for demographics and baseline comorbidities.
Endpoints: Primary endpoints are all-cause mortality and the freedom from aortic-related reintervention. The secondary endpoint is the 30-day complication rate, especially acute kidney injury according to the RIFLE criteria.
详细描述
Background Endovascular abdominal aortic aneurysm repair (EVAR) has gained widespread acceptance in the treatment of patients with abdominal aortic aneurysms (AAA). Prospective randomized trials (RCTs) have demonstrated several short-term advantages over open repair such as less blood loss, operative time, hospital stay, morbidity, and mortality. The applicability of EVAR is limited by the presence of inadequate neck or involvement of the visceral arteries. Thus consequently open AAA repair is now being performed primarily for complex aortic anatomies, such as juxtarenal and pararenal aneurysms. Open repair remains the gold standard for fit patients with complex AAA. In the past decade, an evolution of devices, design, components and delivery systems expanded the application of EVAR in these challenging anatomies. Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe. Initial reports have demonstrated a high technical success rate, low renal dysfunction rate and low morbidity and mortality with promising short- and long-term results. Other reports have shown excessive morbidity and mortality with fenestrated EVAR (FEVAR). Studies comparing endovascular and open repair are sparse, especially when it concerns long-term outcomes. There are till nowadays only two propensity score-matched studies, one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR (F/BEVAR) over open surgical repair (OSR). Vascular surgeons are therefore left with a paucity of data to guide decision-making.
Study objectives:
- Primary aim: Compare Kaplan-Meier freedom from aortic related reintervention and all-cause mortality rate between endovascular and open repair group Primary endpoint: Kaplan-Meier survival rate and Kaplan-Meier aortic related reintervention rate after the patient recruitment ends
- Secondary aim: compare short term outcomes in terms of 30-day complications rate, especially acute kidney injury according to the RIFLE criteria Secondary endpoint: 30-day complications rate, especially acute kidney injury according to the RIFLE criteria
Inclusion criteria:
- All patients (over 18 years of age) with a history of juxta- and pararenal AAA repair from January 2011 to January 2021
- All management strategies will be included (endovascular and open)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (over 18 years of age) with a history of juxta- and pararenal AAA repair from January 2011 to January 2022
- •All management strategies will be included (endovascular and open)
排除标准
- •Patients who are pregnant
- •Patients who are under 18 years of age
- •Patients who have ruptured AAA
- •Patients with thoracoabdominal aortic aneurysm (ThAAA)
- •Patients who have a mycotic AAA
- •Patients with connective tissue disorder
结局指标
主要结局
All-cause Mortality
时间窗: through study completion, an average of 7 year
Any cause of mortality duing follow-up period
Aortic Related Reintervention.
时间窗: through study completion, an average of 7 year
In open surgery this will include patients who were reoperated due to: graft infection, graft thrombosis, pseudoaneurysm formation, secondary AAA rupture. In endovascular group reintervention will include different reasons: endoleak, migration, thrombosis, infection, fracture, secondary AAA rupture.
次要结局
- 30-day Acute Kidney Injury(30-day acute kidney injury)
研究者
Petar Zlatanovic
Medical Doctor
Clinical Centre of Serbia