http://www.theheart.org/web_slides/1171833.do A prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system vs best medical therapy in patients with a stroke and/or transient ischemic attack (TIA) due to presumed paradoxical embolism through a patent foramen ovale (PFO)

1. CLOSURE I

2. CLOSURE I
A Furlan (University Hospitals Case Medical Center, Cleveland, OH)
American Heart Association 2010 Scientific Sessions
• A prospective, multicenter, randomized controlled trial to evaluate the safety and
efficacy of the STARFlex septal closure system vs best medical therapy in
patients with a stroke and/or transient ischemic attack (TIA) due to presumed
paradoxical embolism through a patent foramen ovale (PFO)
• Population and treatment:
909 patients randomized equally to PFO closure as well as six months of
aspirin and clopidogrel (and an additional 18 months of aspirin) or to best
medical therapy—aspirin or warfarin or a combination
• Primary outcome:
Composite of stroke or TIA at two years, all-cause mortality at 30 days, and
neurological mortality between 31 days and two years

3. CLOSURE I: Results
• There was no difference between the two groups in the incidence of the composite
primary end point, as well as rates of stroke or TIA alone
• Major vascular complications and AF, mostly periprocedural, were significantly
more common in the intervention group, but other safety end points were no
different between study arms
Efficacy and safety
End point Device (%) Medical therapy (%) p
Composite end point 5.9 7.7 0.30
Stroke 3.1 3.4 0.77
TIA 3.3 4.6 0.39
Major vascular complications 3.2 0.0 <0.001
AF 5.7 0.7 <0.001
AF=atrial fibrillation

4. CLOSURE I: Commentary*
"Ultimately I think CLOSURE I, if the other ongoing trials show similar results, will
obviously ratchet down the number of endovascular PFO closures [performed]."
- Dr Anthony Furlan
"It is now clear that the selection of patients for PFO closure should be refined, and
we cannot now consider closing PFO in all patients who have stroke of unknown
cause. The term cryptogenic strokes is probably unnecessarily cryptic to many
physicians and patients . . . too vague."
- Dr Pierre Amarenco
*All comments from CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure
(http://www.theheart.org/article/1149945.do)

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