Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale

Department of Neurology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA.
New England Journal of Medicine (Impact Factor: 55.87). 03/2012; 366(11):991-9. DOI: 10.1056/NEJMoa1009639
Source: PubMed


The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.
We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years.
A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events.
In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; number, NCT00201461.).

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    • "This points to the main reason why PFOs are to be closed. The CLOSURE I trial (Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale) in North America was the first randomized trial to be published on PFO closure for prevention of ischemic cerebral events [6] "
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    ABSTRACT: Proof that percutaneous closure of the patent foramen ovale (PFO) is superior to medical treatment is still incomplete. Paradoxical embolism is a rare event occurring over decades rather than years. None of the 4 randomized trials published carried enough patients or was followed up for long enough to reach superiority endpoints. All data, however, point to a benefit of PFO closure. Free wall erosion (exceedingly rare) and triggering of atrial fibrillation (in about 1% of patients) are the only noteworthy complications. They are outweighed by the supposedly prevented events of paradoxical embolisms, such as stroke, transient ischemic attacks, myocardial infarctions, or other systemic embolisms. Medical treatment with perhaps the exception of lifelong oral anticoagulation provides less protection. During a 10-year follow-up of a comparative study the annual mortality was significantly lower in the patients with PFO closure (0.4%) than in those with medical treatment (1.1%, P < 0.03). PFO closure can be accomplished in less than 1 hour with immediate resumption of physical activity. It represents thus a kind of mechanical vaccination.
    06/2014; 2014:129196. DOI:10.1155/2014/129196
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    • "The significance of patent foramen ovale (PFO) is still discussed and studied in patients with cryptogenic stroke. The results of three randomized studies were published in 2012—CLOSURE I [41], PC-Trial [42] and RESPECT [43], comparing the effect of PFO closure with ASA or warfarin drug treatment. REDUCE, a study comparing PFO closure with antiplatelet treatment vs. antiplatelet treatment as monotherapy, is ongoing [44]. "
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    ABSTRACT: Primary and secondary prevention of ischemic stroke represents a significant part of stroke management and health care. Although there are official guidelines concerning stroke management, new knowledge are introduced to them with a slight delay. This article provides an overview of current information on primary and secondary prevention of ischemic stroke. It summarizes information especially in the field of cardioembolic stroke, the use of new anticoagulants and the management of carotid stenosis based on the results of recent clinical studies. The optimal approach in stroke management is to follow these recommendations, to know new strategies and to apply an individual personalized approach in our clinical decisions.
    EPMA Journal, The 06/2014; 5(1):9. DOI:10.1186/1878-5085-5-9
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    • "However, in a subgroup analysis , selected closure devices may be superior to medical therapy without increasing the risk of new-onset atrial fibrillation. Indeed, in the CLO- SURE trial [2] the rate of stroke, transient ischemic attack, or death did not diminish and the risks of major vascular events and atrial fibrillation were increased despite closure of patent foramen ovale, with the StarFlex device, in comparison with the best medical treatment. The benefits of closure seem to be offset by the use of devices acting as antigenic complexes inside the heart which are able to induce the hypersensitivity associated with Kounis syndrome [3]. "
    International journal of cardiology 01/2014; 172(2). DOI:10.1016/j.ijcard.2013.12.189 · 4.04 Impact Factor
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