Patent foramen ovale closure versus medical therapy in cases with cryptogenic stroke, meta-analysis of randomized controlled trials

J Neurol. 2018 Mar;265(3):578-585. doi: 10.1007/s00415-018-8750-x. Epub 2018 Jan 22.


Background: PFO is more common in cases with cryptogenic stroke compared to cases with no stroke or stroke of identified etiology. Several randomized controlled trials (RCTs) comparing PFO closure with medical therapy have been published with controversial findings.

Methods: PubMed, Embase and Cochrane library databases were searched for RCT comparing PFO closure with medical therapy including antiplatelet therapy (aspirin or clopidogrel or combination) or anticoagulation. We identified 5 trials, including 3627 cases. The mean duration of follow-up was 4 years. Relative risk (RR) and 95% confidence intervals (CI) were calculated using fixed and random-effects models.

Results: There was a significant reduction in the incidence of stroke among the PFO closure group compared to medical therapy group, 2.0 versus 4.2%, RR 0.48; 95% CI (0.3, 0.7), p < 0.001. The incidence of AF was higher in the PFO closure group compared to medical therapy group, 4.2 versus 0.7%, respectively, RR 5.9, 95% CI (3, 11), p < 0.001. After exclusion of oral anticoagulants cases (19%), analysis showed a lower incidence of stroke in the PFO closure group (2%) compared to antiplatelet therapy (5.2%), RR 0.4; 95% CI (0.3, 0.6), p < 0.001. There was no significant difference between both groups in the incidence of transient ischemic attacks or all-cause deaths.

Conclusion: PFO closure results in a significant reduction in the recurrence of ischemic stroke compared to medical therapy alone, primarily antiplatelet, among cases with PFO and cryptogenic stroke.

Keywords: Anticoagulation; Antiplatelet therapy; Cryptogenic stroke; Patent foramen ovale; Stroke.

Publication types

  • Comparative Study
  • Meta-Analysis

MeSH terms

  • Brain Ischemia / complications
  • Brain Ischemia / therapy
  • Foramen Ovale, Patent / complications*
  • Foramen Ovale, Patent / therapy*
  • Humans
  • Randomized Controlled Trials as Topic
  • Stroke / complications*
  • Stroke / therapy