title: Closure or medical therapy for cryptogenic stroke with patent foramen ovale.
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. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).
authors.affiliation: Department of Neurology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. anthony.furlan@uhhospitals.org
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Furlan
authors.forename: Mark
authors.initials: M
authors.lastname: Reisman
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Harold
authors.initials: H
authors.lastname: Adams
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Albers
authors.forename: Robert
authors.initials: R
authors.lastname: Felberg
authors.forename: Howard
authors.initials: H
authors.lastname: Herrmann
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Michael
authors.initials: M
authors.lastname: Landzberg
authors.forename: Albert
authors.initials: A
authors.lastname: Raizner
authors.forename: Lawrence
authors.initials: L
authors.lastname: Wechsler
mesh_terms: D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D003131:Combined Modality Therapy; D004359:Drug Therapy, Combination; D019320:Embolism, Paradoxical / Q000517:prevention & control*; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications; D019736:Prostheses and Implants; D055502:Secondary Prevention; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D014859:Warfarin; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin