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.
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborators:
Alfried-Krupp Krankenhaus of Essen, Germany Ammerland Klinik GmbH, Westerstede, Germany Arcispedale Santa Maria Nuova-IRCCS Baystate Medical Center Cantonal Hospital of Aarau, Switzerland East Medical Center Tyler, Texas Klinikum Worms Triemli Hospital Tufts Medical Center Universitaire Ziekenhuizen Leuven University Hospital, Basel, Switzerland University Hospital, Essen University Hospital, Geneva University Hospital, Ghent University Hospital, Zürich University of Lausanne Hospitals