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Internal and Emergency Medicine

, Volume 13, Issue 8, pp 1287–1303 | Cite as

Secondary prevention of cryptogenic stroke in patients with patent foramen ovale: a systematic review and meta-analysis

  • Elisa Maria Fiorelli
  • Tiziana CarandiniEmail author
  • Delia Gagliardi
  • Viviana Bozzano
  • Mattia Bonzi
  • Eleonora Tobaldini
  • Giacomo Pietro Comi
  • Elio Angelo Scarpini
  • Nicola Montano
  • Monica Solbiati
CE - SYSTEMATIC REVIEW

Abstract

The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. We conducted a systematic review and meta-analysis with trial sequential analysis (TSA) of randomized trials. Primary outcomes are stroke or transient ischemic attack (TIA) and all-cause mortality. Secondary outcomes are peripheral embolism, bleeding, serious adverse events, myocardial infarction and atrial dysrhythmias. We performed an intention to treat meta-analysis with a random-effects model. We include six trials (3677 patients, mean age 47.3 years, 55.8% men). PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.38–0.81; I2 = 40%]. The TSA confirms this result. No difference is found in mortality (RR 0.74, 95% CI 0.35–1.60; I2 = 0%), while PFO closure is associated with a higher incidence of atrial dysrhythmias (RR 4.55, 95% CI 2.16–9.60; I2 = 25%). The rate of the other outcomes is not different among the two groups. The comparison between anticoagulant and antiplatelet therapy shows no difference in terms of stroke recurrence, mortality and bleeding. There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.

Keywords

Ischemic stroke Patent foramen ovale Closure device Secondary prevention Systematic reviews Meta-analysis 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Statement of human and animal rights

This article does not contain any studies with human and animals performed by any of the authors.

Informed consent

None.

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Copyright information

© Società Italiana di Medicina Interna 2018

Authors and Affiliations

  • Elisa Maria Fiorelli
    • 1
  • Tiziana Carandini
    • 2
    Email author
  • Delia Gagliardi
    • 3
  • Viviana Bozzano
    • 1
  • Mattia Bonzi
    • 1
  • Eleonora Tobaldini
    • 1
  • Giacomo Pietro Comi
    • 3
  • Elio Angelo Scarpini
    • 2
  • Nicola Montano
    • 1
  • Monica Solbiati
    • 1
  1. 1.Department of Internal MedicineIRCCS Foundation Ca’ Granda, Ospedale Maggiore Policlinico, University of MilanMilanItaly
  2. 2.Neurodegenerative Disease Unit, University of Milan, Dino Ferrari CentreIRCCS Foundation Ca’ Granda, Ospedale Maggiore PoliclinicoMilanItaly
  3. 3.Dino Ferrari Centre, Neuroscience Section, Department of Pathophysiology and Transplantation (DEPT), University of Milan, Neurology UnitIRCCS Foundation Ca’ Granda, Ospedale Maggiore PoliclinicoMilanItaly

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