The effectiveness of patent foramen ovale closure and antiplatelet or anticoagulant therapies for cryptogenic ischemic stroke
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Patent foramen ovale (PFO) occurs in approximately 50% cryptogenic strokes cases. One of the most clinically important consequences of PFO is paradoxical embolization of venous thrombus resulting in recurrent stroke. The aim of this meta-analysis is to compare the efficacy and safety of PFO closure and antiplatelet or anticoagulant therapy alone (medical therapy, MT) in the secondary stroke prevention. Eligible studies for meta-analysis published from May 2008 to May 2018 were identified through a search of PubMed database and two clinical trial registries websites: ClinicalTrials.gov and EU Clinical Trials Register. A meta-analysis was conducted with the use of Statistica software version 13.1. Three studies comprising 2’307 patients were included. The main outcomes were: recurrent stroke occurrence during follow-up period, the frequency of serious adverse events (SAE) and the mortality rate. Statistical significance was found in the assessment of recurrent stroke occurrence when the comparison referred to PFO closure and antiplatelet therapy (RR 0,30, p < 0,05, 95% CI 0,11 – 0,85). There were no significant differences between PFO closure and MT in the frequency of SAE occurrence (RR 1,03, p = 0,73) and mortality rates (RR 0,69, p = 0,39). Current clinical data indicate that PFO closure devices applied to the carefully selected group of young and middle-aged patients with cryptogenic ischemic stroke may be as or more effective than antiplatelet therapy.
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