No benefit for percutaneous closure of patent foramen ovale, compared with medical therapy, in cryptogenic embolism


The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale.
Researchers have investigated whether closure is superior to medical therapy.

Investigator performed a multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and Australia in which the assessors of end points were unaware of the study-group assignments.
Patients with a patent foramen ovale and ischemic stroke, transient ischemic attack ( TIA ), or a peripheral thromboembolic event were randomly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy.

The primary end point was a composite of death, non-fatal stroke, TIA, or peripheral embolism.

The analysis was performed on data for the intention-to-treat population.

The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group.

The primary end point occurred in 7 of the 204 patients ( 3.4% ) in the closure group and in 11 of the 210 patients ( 5.2% ) in the medical-therapy group ( hazard ratio for closure vs medical therapy, HR=0.63; P=0.34 ).

Non-fatal stroke occurred in 1 patient ( 0.5% ) in the closure group and 5 patients ( 2.4% ) in the medical-therapy group ( HR=0.20; P=0.14 ), and TIA occurred in 5 patients ( 2.5% ) and 7 patients ( 3.3% ), respectively ( HR=0.71; P=0.56 ).

In conclusion, closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy. ( Xagena )

Meier B et al, N Engl J Med 2013; 368:1083-1091

XagenaMedicine_2013



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