Valvular & structural heart disease
Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials
Pooled result · Recurrent strokeResult — go to the resultHazard ratio 0.32 95% CI 0.13–0.82Authors' conclusion
In selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts.
Study context
- Population
- Patients with patent foramen ovale (PFO) and cryptogenic stroke
- Participants
- 3,440 patients5 randomized controlled trials (RCTs)
- Comparison
- PFO closure vs medical therapy
- Device closuren = 1,829
- Medical therapyn = 1,611reference
- Outcome
- Recurrent stroke
Pooled result
As reported in the abstract
Hazard ratio
0.32
95% CI 0.13–0.82
P = 0.018
Device closurevs Medical therapy
HR 0.32 (95% CI 0.13–0.82); P = 0.018
Further pooled results
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Stroke, by shunt size (subgroup)Device closurevs Medical therapyLarge shunt | 0.33 (0.16–0.72) | P = 0.005 | |
| Stroke, by shunt size (subgroup)Device closurevs Medical therapySmall shunt | 0.90 (0.50–1.60) | P = 0.712 | |
| 0.10.31310Hazard ratio (log scale) |
Effect of atrial septal aneurysm on outcomes
- No effect from presence or absence of atrial septal aneurysm
- P = 0.994
Safety
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| New-onset AF (primary safety endpoint)I2 = 27.5% | 4.68 (2.19–10.00) | P < 0.001 | |
| 0.10.31310Relative risk (log scale) |
Original publication
Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials. Eur Heart J. Published 24 March 2018. doi:10.
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