Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 18
- 主要终点
- proportion of patients free of any stroke (including fatal stroke) or TIA
研究概览
简要总结
The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates. The aim of the present study is to compare the risk of recurrent stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or receive ATT.
详细描述
Background
The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Even if RCTs are completed successfully, statistical differences may remain undetected with the planned sample sizes. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates.
Objective
- To compare the risk of recurrent stroke and TIA in patients aged ≤ 55 years with PFO and otherwise unexplained stroke who undergo PDC or receive ATT only; 2) To assess the etiological role of PFO for stroke/TIA in patients aged > 55 years; 3) To assess the risk of recurrent stroke/TIA in "high-risk" PFO patients (i.e. those with spontaneous (at rest) or large RLS, coinciding ASA, or multiple previous cerebrovascular events).
Methods
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
- •Age > 18 years
- •Diagnosis of PFO established by transesophageal echocardiography (TEE)
- •Ischemic stroke or transient ischemic attack within the previous 6 months
- •Exclusion Criteria
- •Non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI)
- •Comorbid condition that would interfere with the study
- •Pregnancy
- •History of intracranial bleeding, confirmed arterio-venous malformation, aneurysm or uncontrolled coagulopathy
- •Contraindications for TEE, echocardiographic or iodine contrast media
排除标准
- 未提供
研究组 & 干预措施
1
Patients who receive antithrombotic treatment only
干预措施: Antithrombotic treatment (Drug)
2
Patients who undergo percutaneous device closure
干预措施: percutaneous device closure of PFO (Device)
结局指标
主要结局
proportion of patients free of any stroke (including fatal stroke) or TIA
时间窗: 3 years
次要结局
- influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma(3 years)
- influence of competitive causes of stroke(3 years)
- frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications(30 days and 6 months)