International PFO Consortium
- Conditions
- StrokeTransient Ischemic Attack
- Interventions
- Device: percutaneous device closure of PFODrug: Antithrombotic treatment
- Registration Number
- NCT00859885
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
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.
- Detailed Description
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
1) 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
Multicenter prospective non-randomized study with scheduled 3-years follow-up of patients with PFO and ischemic stroke or TIA. Participating centers: Swiss University Hospitals of Basel, Bern, Geneva, Lausanne and Zurich, the Cantonal Hospital of Aarau, the Triemli Hospital, the Alfried-Krupp Krankenhaus of Essen, the University Hospital of Essen, the Klinikum Worms gGmbH, Tufts Medical Center, Baystate Medical Center, the East Medical Center Tyler, and the University Hospital of Leuven.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2 percutaneous device closure of PFO Patients who undergo percutaneous device closure 1 Antithrombotic treatment Patients who receive antithrombotic treatment only
- Primary Outcome Measures
Name Time Method proportion of patients free of any stroke (including fatal stroke) or TIA 3 years
- Secondary Outcome Measures
Name Time Method influence of competitive causes of stroke 3 years influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma 3 years frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications 30 days and 6 months
Trial Locations
- Locations (18)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Leuven University Hospital
🇧🇪Leuven, Belgium
Ammerland Klinik GmbH
🇩🇪Westerstede, Germany
Basel University Hospital
🇨🇭Basel, Switzerland
Lausanne University Hospital
🇨🇭Lausanne, Switzerland
Zürich Triemli Hospital
🇨🇭Zürich, Switzerland
Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS
🇮🇹Reggio Emilia, Italy
Cantonal Hospital of Aarau
🇨🇭Aarau, Switzerland
University Hospital Doctor Josep Trueta
🇪🇸Girona, Spain
University Hospital Gent
🇧🇪Gent, Belgium
Alfried Krupp Hospital
🇩🇪Essen, Germany
Essen University Hospital
🇩🇪Essen, Germany
Klinikum Worms gGmbH
🇩🇪Worms, Germany
Department of Neurology, Bern University Hospital, Bern
🇨🇭Bern, Switzerland
Geneva University Hospital
🇨🇭Geneva, Switzerland
East Medical Center
🇺🇸Tyler, Texas, United States
Zürich University Hospital
🇨🇭Zürich, Switzerland