CLOSURE I trial - Summary & Results
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CLOSURE I trial - Summary & Results

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http://www.theheart.org/web_slides/1171833.do ...

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)

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CLOSURE I trial - Summary & Results CLOSURE I trial - Summary & Results Presentation Transcript

  • CLOSURE I
  • CLOSURE IA 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
  • 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 armsEfficacy 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 <0.001AF=atrial fibrillation
  • CLOSURE I: Commentary*"Ultimately I think CLOSURE I, if the other ongoing trials show similar results, willobviously 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, andwe cannot now consider closing PFO in all patients who have stroke of unknowncause. The term cryptogenic strokes is probably unnecessarily cryptic to manyphysicians 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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