title: Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials.
abstract: BACKGROUND
  There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke.
  
  
  METHODS
  A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs).
  
  
  RESULTS
  A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n = 1150) and medical therapy (n = 1153). Mean follow-up was 2.5 years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01; p = 0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98; p = 0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96; p = 0.038).
  
  
  CONCLUSIONS
  In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.
authors: Irbaz Bin
authors: IB
authors: Riaz
authors: Abhijeet
authors: A
authors: Dhoble
authors: Ahmad
authors: A
authors: Mizyed
authors: Chiu-Hsieh
authors: CH
authors: Hsu
authors: Muhammad
authors: M
authors: Husnain
authors: Justin Z
authors: JZ
authors: Lee
authors: Kapildeo
authors: K
authors: Lotun
authors: Department of Cardiovascular Diseases, University of Arizona, 3950 S Country Club Road, Suite 200, Tucson, AZ 85714, USA. klee@shc.arizona.edu.
authors: Kwan S
authors: KS
authors: Lee
mesh_terms: D006328:Cardiac Catheterization / Q000379:methods*; D015331:Cohort Studies; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D006344:Heart Septal Defects, Atrial; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D016896:Treatment Outcome