Transcatheter Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: A Meta-Analysis of Randomized Controlled Trials

Cerebrovasc Dis. 2018;45(3-4):162-169. doi: 10.1159/000487959. Epub 2018 Mar 29.


Background: Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy.

Method: A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items "PFO or patent foramen ovale", "paradoxical embolism", "PFO closure" and "stroke". Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes.

Result: Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I2 heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20-0.91, p = 0.03).

Conclusion: Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy.

Keywords: Cryptogenic stroke; Medical therapy; Patent foramen ovale; Patent foramen ovale closure.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Adult
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiovascular Agents / adverse effects
  • Cardiovascular Agents / therapeutic use*
  • Embolism, Paradoxical / diagnosis
  • Embolism, Paradoxical / etiology
  • Embolism, Paradoxical / physiopathology
  • Embolism, Paradoxical / therapy*
  • Female
  • Foramen Ovale, Patent / complications
  • Foramen Ovale, Patent / diagnosis
  • Foramen Ovale, Patent / physiopathology
  • Foramen Ovale, Patent / therapy*
  • Humans
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Recurrence
  • Risk Factors
  • Secondary Prevention / instrumentation
  • Secondary Prevention / methods*
  • Stroke / diagnosis
  • Stroke / etiology
  • Stroke / physiopathology
  • Stroke / prevention & control*
  • Treatment Outcome


  • Cardiovascular Agents