CLOSURE I
Trial question
What is the role of closure of a patent foramen ovale among patients with cryptogenic stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 909
909 patients (438 female, 471 male).
Inclusion criteria: patients between 18 and 60 years of age who presented with a cryptogenic stroke or TIA and had a patent foramen ovale.
Key exclusion criteria: any identified potential cause of ischemic stroke or TIA other than the patent foramen ovale, such as clinically significant carotid artery stenosis, complex aortic arch atheroma, clinically significant LV dysfunction or LV aneurysm, or AF.
Interventions
N=447 percutaneous closure (with a percutaneous STARFlex device plus antiplatelet therapy with clopidogrel 75 mg daily for 6 months and aspirin 81 or 325 mg daily for 2 years).
N=462 medical therapy alone (with warfarin (INR target 2.0-3.0), aspirin 325 mg daily, or both).
Primary outcome
Rate of stroke or transient ischemic attack during 2 years of follow-up
5.5%
6.8%
6.8 %
5.1 %
3.4 %
1.7 %
0.0 %
Percutaneous
closure
Medical therapy
alone
No significant
difference ↔
No significant difference in the rate of stroke or TIA during 2 years of follow-up (5.5% vs. 6.8%).
Secondary outcomes
No significant difference in stroke (2.9% vs. 3.1%).
No significant difference in TIA (3.1% vs. 4.1%).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in AF (5.7% vs. 0.7%).
Conclusion
In patients between 18 and 60 years of age who presented with a cryptogenic stroke or TIA and had a patent foramen ovale, percutaneous closure was not superior to medical therapy alone with respect to the rate of stroke or TIA during 2 years of follow-up.
Reference
Furlan AJ, Reisman M, Massaro J et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012 Mar 15;366(11):991-9.
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