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

Elisa Maria Fiorelli, Tiziana Carandini, Delia Gagliardi, Viviana Bozzano, Mattia Bonzi, Eleonora Tobaldini, Giacomo Pietro Comi, Elio Angelo Scarpini, Nicola Montano, Monica Solbiati

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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.

Original languageEnglish
Pages (from-to)1287-1303
JournalInternal and Emergency Medicine
Volume13
Issue number8
DOIs
Publication statusPublished - 2018

Fingerprint

Patent Foramen Ovale
Secondary Prevention
Meta-Analysis
Stroke
Transient Ischemic Attack
Anticoagulants
Odds Ratio
Recurrence
Mortality
Hemorrhage
Intention to Treat Analysis
Therapeutics
Embolism
Myocardial Infarction
Incidence

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Emergency Medicine

Cite this

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title = "Secondary prevention of cryptogenic stroke in patients with patent foramen ovale: a systematic review and meta-analysis",
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 = "Closure device, Ischemic stroke, Meta-analysis, Patent foramen ovale, Secondary prevention, Systematic reviews",
author = "Fiorelli, {Elisa Maria} and Tiziana Carandini and Delia Gagliardi and Viviana Bozzano and Mattia Bonzi and Eleonora Tobaldini and Comi, {Giacomo Pietro} and Scarpini, {Elio Angelo} and Nicola Montano and Monica Solbiati",
year = "2018",
doi = "10.1007/s11739-018-1909-8",
language = "English",
volume = "13",
pages = "1287--1303",
journal = "Internal and Emergency Medicine",
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TY - JOUR

T1 - Secondary prevention of cryptogenic stroke in patients with patent foramen ovale

T2 - a systematic review and meta-analysis

AU - Fiorelli, Elisa Maria

AU - Carandini, Tiziana

AU - Gagliardi, Delia

AU - Bozzano, Viviana

AU - Bonzi, Mattia

AU - Tobaldini, Eleonora

AU - Comi, Giacomo Pietro

AU - Scarpini, Elio Angelo

AU - Montano, Nicola

AU - Solbiati, Monica

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

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