Percutaneous closure of patent foramen ovale vs. medical treatment for patients with history of cryptogenic stroke: A systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Patients with history of cryptogenic stroke are more likely to have a patent foramen ovale (PFO) and should be managed with antithrombotic agents, while the alternative option is percutaneous closure of PFOs. Our aim was to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous closure vs. medical treatment for patients with PFO and prior cryptogenic stroke.

Methods: Medline, Scopus and Cochrane databases were reviewed. A random-effect model meta-analysis was used and I-square was utilized to assess the heterogeneity. New ischemic stroke was defined as the primary endpoint. A sensitivity analysis was performed for Amplatzer device. Subgroup analyses were performed for different patient and PFO characteristics for the composite endpoints as defined by the included RCTs.

Results: In total of 3440 patients were included in this meta-analysis. Closure devices were superior to medical therapy for prevention of recurrent ischemic strokes (HR = 0.29; CI: 0.02-0.56), but were associated with increased risk of new onset of atrial fibrillation (AF) and atrial flutter (RR = 4.67; CI: 2.22-9.81). However, in the sensitivity analysis for Amplatzer device, there was no difference between the two groups in new onset of atrial arrhythmias. Closure devices were superior across all different subgroups when compared to medical treatment with the exception of patients with a small shunt.

Conclusion: This meta-analysis shows that closure devices for patients with PFO and history of cryptogenic stroke can significantly decrease the risk of a new ischemic stroke. The use of Amplatzer device was not associated with increased risk of newly diagnosed atrial arrhythmias.