Comparison of Open Surgery, Hybrid and Endovascular Repair for Complex TASC C/D Aortoiliac Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Background:
The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR.
Aim:
The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions.
Methodology:
This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data.
Endpoints:
Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.
详细描述
Background:
The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results (85%-90% at five years and 75%-80% at ten years), it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. HR has evolved as an attractive minimally invasive alternative to OR, especially if the disease extends to the femoral bifurcation, with the potential advantages of lower perioperative morbidity and a shorter hospital stay. On the other hand, ER offers an attractive alternative with durable results (five-year primary and secondary patency rates ranging from 60% to 86% and 80% to 98%, respectively), especially in less extensive AID. When combined with low perioperative morbidity it makes ER generally preferable for patients with more severe co-morbid conditions. Thus, surgical approaches for extensive AID have changed considerably over the last years, primarily due to increased ER. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR. However, currently, there are no randomized control trials nor large observational trials comparing these treatment option for complex (TASC C and D) aortoiliac lesions. Vascular surgeons are therefore left with a paucity of data to guide decision-making.
Sample size:
To ensure sufficient statistical power to answer hypothetical questions, approximately 900 subjects will be entered into the database. Major adverse limb event rate is the primary endpoint being used to calculate the sample size. Assuming a difference in terms of MALE, 243 patients would be required in each arm to achieve a statistical power of 85% at p=0.05. With three arms (endovascular versus open), assuming a 20% rate of missing data, a total N of 875 patients is required.
Research Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（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 atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022
- •All management strategies will be included (endovascular, hybrid, and open)
排除标准
- •Patients who are pregnant
- •Patients who are under 18 years of age
- •Patients who have acute limb ischemia or acute on chronic ischemia
- •Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection
- •Patients who were treated in conservative manner
- •Patients who underwent primary major amputation
- •Patients with limited life expectancy (less than 2 years)
结局指标
主要结局
All-cause mortality
时间窗: Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years)
Overall mortality in all treatment arms
Major adverse limb event (MALE)
时间窗: Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years)
Major amputations (below and above the knee), new onset acute limb ischaemia of the treated extremity, and reintervention on the already treated arterial segment (aortoiliac segment and femoral bifurcation, excluding distal infrainguinal disease).
次要结局
- 30-day complication(Short-term (30-days))
- Primary patency(Short-term (30-days), mid-term (between 1-5 years), long-term (more than 5 years))
研究者
Petar Zlatanovic
Principal investigator
Clinical Centre of Serbia