Percutaneous closure of patent foramen ovale in cryptogenic embolism

Bernhard Meier, Bindu Kalesan, Heinrich P Mattle, Ahmed A Khattab, David Hildick-Smith, Dariusz Dudek, Grethe Andersen, Reda Ibrahim, Gerhard Schuler, Antony S Walton, Andreas Wahl, Stephan Windecker, Peter Jüni, PC Trial Investigators, Martin Dennis

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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; number, NCT00166257.).

Original languageEnglish
Pages (from-to)1083-91
Number of pages9
JournalNew England Journal of Medicine
Issue number12
Publication statusPublished - 21 Mar 2013

Keywords / Materials (for Non-textual outputs)

  • Adult
  • Cardiac Catheterization
  • Embolism
  • Female
  • Fibrinolytic Agents
  • Follow-Up Studies
  • Foramen Ovale, Patent
  • Humans
  • Intention to Treat Analysis
  • Ischemic Attack, Transient
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Risk
  • Secondary Prevention
  • Septal Occluder Device
  • Single-Blind Method
  • Stroke
  • Treatment Outcome


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