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Positive Long-Term Data Plug Doubts Over PFO-Closure Stroke Benefits

 
• By Reed Miller

Data from the REDUCE, CLOSE, and RESPECT trials, published in the New England Journal of Medicine, showed that closing a patent foramen ovale with a percutaneous closure device can reduce the risk of ischemic stroke in patients who have already had a cryptogenic stroke. Observers believe these trials showed a benefit of PFO closure in this population after previous trials failed to show a benefit largely because they did a better job of only selecting patients most likely to benefit.

Results of three clinical trials, published in the New England Journal of Medicine, support percutaneous closure of patent foramen ovale (PFO) to prevent recurrent stroke after a cryptogenic stroke, which could lead to a change in the professional guidelines on the treatment of these patients and help the companies trying to market PFO-closure devices.

On Sept. 14, The New England Journal of Medicine published long-term results of three clinical trials comparing PFO-closure with a transcatheter device and medical therapy to medical therapy alone:

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