Key result
Transcatheter patent foramen ovale closure reduced the risk of recurrent ischemic stroke compared to medical therapy (OR 0.22) but increased the risk of new-onset atrial fibrillation.
Why the study?
To compare devices for patent foramen ovale closure, evaluate the safety and efficacy of transcatheter closure in preventing neurological events versus medical therapy in stroke patients, and assess atrial fibrillation risk.
Does transcatheter PFO closure reduce recurrences of ischemic stroke compared to medical therapy in patients with cryptogenic stroke and PFO?
Population
3560 patients across six randomized controlled trials
Comparison
Transcatheter PFO closure devices vs medical therapy
Design
Bayesian network meta-analysis of randomized controlled trials
Authors
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Supports PFO closure for cryptogenic stroke with PFO; confirms stroke reduction despite AF increase in updated meta-analysis.
Meta-Analysis (n=3,560)
Open-label
RCTs
Yes
Does transcatheter PFO closure reduce recurrences of ischemic stroke compared to medical therapy in patients with cryptogenic stroke and PFO?
Odds Ratio: 0.22 (95% CI 0.05–0.7)
Number Needed to Treat: 28
Transcatheter PFO closure in patients with cryptogenic stroke reduces recurrent stroke risk compared to medical therapy but significantly increases the risk of new-onset atrial fibrillation, though the likelihood of being helped outweighs the harm when considering only serious AF.
Varotto et al. (2020) conducted a meta-analysis in Cryptogenic stroke and patent foramen ovale (n=3,560). Transcatheter patent foramen ovale closure vs. Medical therapy was evaluated on Recurrences of ischemic stroke (OR 0.22, 95% CI 0.05-0.70). Transcatheter patent foramen ovale closure reduced the risk of recurrent ischemic stroke compared to medical therapy (OR 0.22) but increased the risk of new-onset atrial fibrillation.
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