Patent Foramen Ovale Closure for Cryptogenic Stroke: Two More Studies

Results were negative in one study and ambiguous in another.

In the CLOSURE I trial, published in 2012 (JW Neurol Mar 14 2012), percutaneous closure of patent foramen ovale (PFO) with the STARFlex device did not prevent recurrent stroke in patients with cryptogenic stroke and PFO. Now, in two more industry-sponsored randomized trials — the RESPECT and PC trials, adults (age, ≤60) with cryptogenic ischemic stroke and PFO received either the percutaneously deployed Amplatzer PFO Occluder or antithrombotic medical therapy alone.

In the PC trial (414 patients; mean follow-up, 4 years), the incidence of the primary outcome (stroke, transient ischemic attack, peripheral embolism, or death) was similar in the PFO-closure and medical-therapy groups (3.4% vs. 5.2%; P=0.34).

In intent-to-treat analysis in the RE…

Reviewing Author

Allan S. Brett, MD

Disclosures

Nothing to disclose

Allan S. Brett, MD

Disclosures

Nothing to disclose

Patent Foramen Ovale Closure for Cryptogenic Stroke: Two More Studies

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Reviewing Author