February 1, 2014EuroIntervention
Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies
Why the study?
Does patent foramen ovale closure reduce recurrent stroke in patients with cryptogenic stroke compared to medical therapy?
Population
4,534 patients with cryptogenic stroke (2,303 from 3 RCTs and 2,231 from 11 observational studies)
Comparison
Patent foramen ovale (PFO) closure vs Medical therapy
Design
Meta-analysis
Authors
Discussion
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Member takes
Implication
PFO closure lacks overall superiority for recurrent stroke; extends device-specific evidence for AMPLATZER while cautioning against routine use.
Structured PICO
Does patent foramen ovale closure reduce recurrent stroke in patients with cryptogenic stroke compared to medical therapy?
P
Population
4,534 patients with cryptogenic stroke (2,303 from 3 RCTs and 2,231 from 11 observational studies)
I
Intervention
Patent foramen ovale (PFO) closure
C
Comparator
Medical therapy
O
Outcome
Recurrent strokehard clinical
While overall RCT data did not show a statistically significant reduction in recurrent stroke with PFO closure compared to medical therapy, pooling data for the AMPLATZER device demonstrated a significant benefit.
Limitations
- High potential for baseline confounders in observational studies
Cite This Study
Capodanno et al. (2014) studied this question.