title: Percutaneous closure of patent foramen ovale in cryptogenic embolism.
abstract: BACKGROUND
  The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale. We investigated whether closure is superior to medical therapy.
  
  
  METHODS
  We performed a multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and Australia in which the assessors of end points were unaware of the study-group assignments. Patients with a patent foramen ovale and ischemic stroke, transient ischemic attack (TIA), or a peripheral thromboembolic event were randomly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy. The primary end point was a composite of death, nonfatal stroke, TIA, or peripheral embolism. Analysis was performed on data for the intention-to-treat population.
  
  
  RESULTS
  The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group. The primary end point occurred in 7 of the 204 patients (3.4%) in the closure group and in 11 of the 210 patients (5.2%) in the medical-therapy group (hazard ratio for closure vs. medical therapy, 0.63; 95% confidence interval [CI], 0.24 to 1.62; P=0.34). Nonfatal stroke occurred in 1 patient (0.5%) in the closure group and 5 patients (2.4%) in the medical-therapy group (hazard ratio, 0.20; 95% CI, 0.02 to 1.72; P=0.14), and TIA occurred in 5 patients (2.5%) and 7 patients (3.3%), respectively (hazard ratio, 0.71; 95% CI, 0.23 to 2.24; P=0.56).
  
  
  CONCLUSIONS
  Closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT00166257.).
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland. bernhard.meier@insel.ch
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Grethe
authors.initials: G
authors.lastname: Andersen
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Antony S
authors.initials: AS
authors.lastname: Walton
authors.forename: Andreas
authors.initials: A
authors.lastname: Wahl
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D006801:Humans; D057194:Intention to Treat Analysis; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012306:Risk; D055502:Secondary Prevention; D055989:Septal Occluder Device / Q000009:adverse effects; D016037:Single-Blind Method; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents