title: PFO closure vs. medical therapy in cryptogenic stroke or transient ischemic attack: a systematic review and meta-analysis.
abstract: OBJECTIVE
  This study aims to assess whether patent foramen ovale (PFO) closure is superior to medical therapy in preventing recurrence of cryptogenic ischemic stroke or transient ischemic attack (TIA).
  
  
  METHODS
  We searched PubMed for randomized trials which compared PFO closure with medical therapy in cryptogenic stroke/TIA using the items: "stroke or cerebrovascular accident or TIA" and "patent foramen ovale or paradoxical embolism" and "trial or study".
  
  
  RESULTS
  Among 650 potentially eligible articles, 3 were included including 2303 patients. There was no statistically significant difference between PFO-closure and medical therapy in ischemic stroke recurrence (1.91% vs. 2.94% respectively, OR: 0.64, 95%CI: 0.37-1.10), TIA (2.08% vs. 2.42% respectively, OR: 0.87, 95%CI: 0.50-1.51) and death (0.60% vs. 0.86% respectively, OR: 0.71, 95%CI: 0.28-1.82). In subgroup analysis, there was significant reduction of ischemic strokes in the AMPLATZER PFO Occluder arm vs. medical therapy (1.4% vs. 3.04% respectively, OR: 0.46, 95%CI: 0.21-0.98, relative-risk-reduction: 53.2%, absolute-risk-reduction: 1.6%, number-needed-to-treat: 61.8) but not in the STARFlex device (2.7% vs. 2.8% with medical therapy, OR: 0.93, 95%CI: 0.45-2.11). Compared to medical therapy, the number of patients with new-onset atrial fibrillation (AF) was similar in the AMPLATZER PFO Occluder arm (0.72% vs. 1.28% respectively, OR: 1.81, 95%CI: 0.60-5.42) but higher in the STARFlex device (0.64% vs. 5.14% respectively, OR: 8.30, 95%CI: 2.47-27.84).
  
  
  CONCLUSIONS
  This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA. In subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset AF, however. This observation should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence.
authors.affiliation: Department of Medicine & Research Lab, University of Thessaly, Larissa, Greece. Electronic address: gntaios@med.uth.gr.
authors.forename: G
authors.initials: G
authors.lastname: Ntaios
authors.forename: V
authors.initials: V
authors.lastname: Papavasileiou
authors.forename: K
authors.initials: K
authors.lastname: Makaritsis
authors.forename: P
authors.initials: P
authors.lastname: Michel
mesh_terms: D054092:Foramen Ovale, Patent / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D055502:Secondary Prevention / Q000379:methods; D020521:Stroke / Q000188:drug therapy* / Q000453:epidemiology / Q000601:surgery*
keywords: AMPLATZER PFO Occluder; Cryptogenic stroke; PFO closure; Paradoxical embolism; Patent foramen ovale; STARFlex device