Journal article
Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale
The New England journal of medicine, Vol.366(11), pp.991-999
2012
DOI: 10.1056/NEJMoa1009639
PMID: 22417252
Abstract
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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
Details
- Title: Subtitle
- Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale
- Creators
- Anthony J FURLAN - University Hospitals Case Medical Center, Cleveland, United StatesMark REISMAN - Swedish Medical Center, Seattle, United StatesAlbert RAIZNER - Methodist Hospital, Houston, United StatesLawrence WECHSLER - University of Pittsburgh, Pittsburgh, United StatesJoseph MASSARO - Harvard Clinical Research Institute, United StatesLaura MAURI - Harvard Clinical Research Institute, United StatesHarold Adams - University of Iowa, Iowa City, United StatesGregory W ALBERS - Stanford University Medical Center, Palo Alto, CA, United StatesRobert FELBERG - Geisinger Medical Center, Danville, PA, United StatesHoward HERRMANN - University of Pennsylvania, Philadelphia, United StatesSaibal KAR - Cedars―Sinai Medical Center, Los Angeles, United StatesMichael LANDZBERG - Brigham and Women's Hospital, Boston, United States
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.366(11), pp.991-999
- Publisher
- Massachusetts Medical Society; Waltham, MA
- DOI
- 10.1056/NEJMoa1009639
- PMID
- 22417252
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2012
- Academic Unit
- Neurology; Iowa Neuroscience Institute
- Record Identifier
- 9984020778102771
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