Key result
PFO closure shows no net clinical benefit over medical therapy as increased AFib offsets fewer strokes.
Why the study?
The ideal treatment for patent foramen ovale in patients with cryptogenic stroke remains controversial.
Does PFO closure improve net clinical benefit compared to medical treatment in patients with cryptogenic stroke?
Comparison
PFO closure vs medical treatment
Design
Systematic review and meta-analysis of RCTs
Authors
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PFO closure yields no net clinical benefit versus medical therapy; challenges routine use and supports individualized selection in trials.
Meta-Analysis (n=3,750)
Does PFO closure improve net clinical benefit compared to medical treatment in patients with cryptogenic stroke?
PFO closure does not provide a superior overall net clinical benefit compared to medical therapy in cryptogenic stroke patients, as the reduction in stroke is offset by an increase in atrial fibrillation/flutter, highlighting the need for individualized patient selection.
Kolokathis et al. (2022) conducted a meta-analysis in Cryptogenic stroke with patent foramen ovale (n=3,750). PFO closure vs. Medical treatment was evaluated on Net clinical benefit (NCB-1), defined as the cumulative incidence of stroke, major bleeding, atrial fibrillation/flutter, and serious procedural or device complications. PFO closure versus medical treatment showed no significant difference in net clinical benefit, despite a 44% relative decrease in stroke (95% CI, 21-60%) and increased atrial fibrillation.
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