Scandinavian Trial of Uncomplicated Aortic Dissection Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 554
- 试验地点
- 32
- 主要终点
- Survival
研究概览
简要总结
The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for "complicated" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of "uncomplicated" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vascular Surgery.
This randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.
Sample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.
详细描述
This randomized, open-label, two-armed controlled study addresses the question of whether thoracic endovascular aortic repair (TEVAR) alters 5-year survival among patients with an uncomplicated Stanford type-B aortic dissection (uTBAD). Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment.
Primary hypothesis:
The null hypothesis for this trial states that the five-year survival results for patients treated with either SMT or SMT + TEVAR are equivalent.
- Background
The incidence of a Stanford type-B thoracic aortic dissection (TBAD) is estimated at 3.9 - 6.0 per 100,000 person years, although this may be an underestimate. These account for approximately 30-40% of all types of aorta dissection. The diagnosis of TBAD is further classified with respect to time: acute, ≤ 14 days, subacute, 15-90 days, and chronic, > 90 days. Approximately 40-50% of ABDs are considered complicated which, according to the European Society of Vascular Surgery, is defined as the presence of one or more of the following: rupture and/or hypotension/shock, organ malperfusion, rapid aortic expansion, paraplegia/paraparesis, peri-aortic haematoma, or intractable pain or hypertension. In the absence of these complications, the dissection is considered uncomplicated. In-hospital survival for these patients has been reported as approximately 90%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data are collected and stored using the Research Electronic Data Capture (REDCap) software. Overall access is granted only to the Data and Safety Monitoring Committee and the Trial Steering Committee.
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 subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration.
排除标准
- •Subjects with no signed informed consent.
- •Subjects presenting with a complicated type B aortic dissection according to the above definition.
- •Subjects previously treated in their descending aorta, either open surgery or TEVAR.
- •Subjects with pre-existing thoracoabdominal aortic aneurysm.
- •Subjects with other aortic pathology with an indication for intervention that requires TEVAR.
- •Subjects with traumatic aortic dissections.
- •Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome.
- •Subjects with a clinically estimated life expectancy < 2 years.
- •Subjects with dementia.
- •Pregnant or nursing subjects.
- •Subjects with current sepsis.
- •Subjects currently participating in other clinical interventional trials.
结局指标
主要结局
Survival
时间窗: Five years
Overall survival
次要结局
- Reintervention(Five years)
- Neurological injury(Five years)
- 12-Item Short Form Health Survey(Five years)
- Aortic-related mortality(Five years)
- EuroQOL-5D-5L(Five years)
- Hospital Anxiety and Depression Score(Five years)