title: Risk of recurrent cerebrovascular events in patients with cryptogenic stroke or transient ischemic attack and patent foramen ovale: the FORI (Foramen Ovale Registro Italiano) study.
abstract: BACKGROUND
  The optimal management of patients with cryptogenic ischemic stroke found to have a patent foramen ovale (PFO) at diagnostic workup remains unclear. The aims of this observational multicenter study were to evaluate: (1) the risk of recurrent cerebrovascular events in patients with cryptogenic minor ischemic stroke or transient ischemic attack (TIA) and PFO who either underwent percutaneous PFO closure or received only medical treatment, and (2) the risk factors associated with recurrent events.
  
  
  METHODS
  Consecutive patients (aged 55 years or less) with first-ever cryptogenic minor ischemic stroke or TIA and PFO were recruited in 13 Italian hospitals between January 2006 and September 2007 and followed up for 2 years.
  
  
  RESULTS
  238 patients were included in the study (mean age 42.2 ± 10.0 years; 118 males); 117 patients (49.2%) received only antithrombotic therapy while 121 patients underwent percutaneous PFO closure (50.8%). Stroke as the qualifying event was more common in the medical treatment group (p = 0.01). The presence of atrial septal aneurysm and evidence of 20 bubbles or more on transcranial Doppler were more common in the PFO closure group (p = 0.002 and 0.02). Eight patients (6.6%) experienced a nonfatal complication during PFO closure. At the 2-year follow-up, 17 recurrent events (TIA or stroke; 3.6% per year) were observed; 7 of these events (2.9% per year) occurred in the percutaneous PFO closure group and 10 events (4.2% per year) in the medical treatment group. The rate of recurrent stroke was 0.4% per year in patients who underwent percutaneous closure (1 event) and 3.4% per year in patients who received medical treatment (8 events). On multivariate analysis, percutaneous closure was not protective in preventing recurrent TIA or stroke (OR = 0.1, 95% CI = 0.02-1.5, p = 0.1), while it was barely protective in preventing recurrent stroke (OR = 0.1, 95% CI = 0.0-1.0, p = 0.053).
  
  
  CONCLUSIONS
  The results of this observational, nonrandomized study suggest that PFO closure might be superior to medical therapy for the prevention of recurrent stroke. Periprocedural complications were the trade-off for this clinical benefit. Controlled randomized clinical trials comparing percutaneous closure with medical management are required.
authors.affiliation: Stroke Unit, Division of Cardiovascular Medicine, University of Perugia, Perugia, Italy. mpaciaroni@med.unipg.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Paciaroni
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Agnelli
authors.forename: Andrea
authors.initials: A
authors.lastname: Bertolini
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pezzini
authors.forename: Alessandro
authors.initials: A
authors.lastname: Padovani
authors.forename: Valeria
authors.initials: V
authors.lastname: Caso
authors.forename: Michele
authors.initials: M
authors.lastname: Venti
authors.forename: Andrea
authors.initials: A
authors.lastname: Alberti
authors.forename: Rosa Antonietta
authors.initials: RA
authors.lastname: Palmiero
authors.forename: Paolo
authors.initials: P
authors.lastname: Cerrato
authors.forename: Giorgio
authors.initials: G
authors.lastname: Silvestrelli
authors.forename: Alessia
authors.initials: A
authors.lastname: Lanari
authors.forename: Paolo
authors.initials: P
authors.lastname: Previdi
authors.forename: Francesco
authors.initials: F
authors.lastname: Corea
authors.forename: Alessandro
authors.initials: A
authors.lastname: Balducci
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferri
authors.forename: Francesca
authors.initials: F
authors.lastname: Falcinelli
authors.forename: Esmeralda
authors.initials: E
authors.lastname: Filippucci
authors.forename: Paolo
authors.initials: P
authors.lastname: Chiocchi
authors.forename: Fabio Chiodo
authors.initials: FC
authors.lastname: Grandi
authors.forename: Laura
authors.initials: L
authors.lastname: Ferigo
authors.forename: Rosa
authors.initials: R
authors.lastname: Musolino
authors.forename: Anna
authors.initials: A
authors.lastname: Bersano
authors.forename: Isabella
authors.initials: I
authors.lastname: Ghione
authors.forename: Simona
authors.initials: S
authors.lastname: Sacco
authors.forename: Antonio
authors.initials: A
authors.lastname: Carolei
authors.forename: Antonio
authors.initials: A
authors.lastname: Baldi
authors.forename: Walter
authors.initials: W
authors.lastname: Ageno
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D016009:Chi-Square Distribution; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D054092:Foramen Ovale, Patent / Q000150:complications / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D007558:Italy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial
chemical_list: D005343:Fibrinolytic Agents