Patent foramen ovale (PFO) closure in patients with prior cryptogenic stroke, TIA or systemic arterial
embolism results in Increased risk of incident atrial arrhythmias. PFO closure has not been shown to
significantly reduce the risk of recurrent stroke/TIA (RR 0.73, P=0.10); however, an increased risk of incident
atrial arrhythmias has been detected (RR 3.67, P<0.0001).
Patent foramen ovale closure versus medical therapy for stroke prevention: meta analysis of randomized
trials and review of heterogeneity in meta analyses
Canadian Journal of Cardiology, 06/02/2014 Evidence Based Medicine Review Article Clinical Article
Udell JA, et al. – The authors sought to determine the efficacy and safety of transcatheter patent foramen
ovale (PFO) closure compared with antithrombotic therapy for secondary prevention of cerebrovascular
events among patients with cryptogenic stroke. Meta–analysis of RCTs assessing transcatheter PFO
closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not
demonstrate benefit compared with antithrombotic therapy, and suggests potential risks.
They performed a systematic review and meta–analysis of Medline and Embase (inception – March 2013)
for randomized clinical trials (RCTs) comparing transcatheter PFO closure to medical therapy in subjects
with cryptogenic stroke.
Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety
events from published manuscripts and appendices.
Risk ratios (RR) and 95% CIs for the composite of stroke or TIA, and adverse cardiovascular events
including atrial fibrillation/flutter were constructed.
Three RCTs of 2,303 subjects with prior stroke, TIA, or systemic arterial embolism (mean age 45.7 years,
47.3% women, mean follow–up 2.6 years) were included.
PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs. 5.2%; RR 0.73, 95% CI,
0.50–1.07; P=0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs.
1.0%; RR 3.67, 95% CI, 1.95–6.89; P<0.0001).
No significant heterogeneity was detected for any endpoint among subgroups of patients stratified by age,
sex, index cardiovascular event, device type, inter–atrial shunt size, and presence of an atrial septal
aneurysm (all P–interactions ≥0.09).