Patent foramen ovale closure reduces risk of stroke in three trials
Key clinical point: Closure of patent foramen ovale in patients who have experienced a prior stroke of unknown cause lowers the risk of recurrent stroke, compared with medical therapy alone.
Major finding: Patent foramen ovale closure was associated with a 45%-97% reduction in the incidence of recurrent ischemic stroke, compared with treatment with antiplatelets or anticoagulants alone.
Data source: The CLOSE, REDUCE, and RESPECT randomized, controlled trials in patients with patent foramen ovale who had experienced a cryptogenic ischemic stroke.
Disclosures: The CLOSE trial was supported by the French Ministry of Health. Fourteen authors reported funding, grants, consultancies and other support from the pharmaceutical industry. The REDUCE trial was supported by W.L. Gore and Associates, and 11 authors declared grants or fees from W.L. Gore and Associates. The RESPECT trial was supported by St. Jude Medical. Eight authors declared grants, fees, or nonfinancial support from St. Jude Medical. One also declared grants and fees from the pharmaceutical industry.
The evidence for causation of embolic stroke in any given person is, of course, circumstantial (for example, atrial fibrillation or carotid stenosis), and it seems reasonable that the presence of a PFO and a sizable interatrial shunt should similarly no longer result in the categorization of a stroke as cryptogenic.
One conclusion from previous trials of closure of patent foramen ovale is that the potential benefit from closure is determined on the basis of the positive characteristics of the PFO rather than on the basis of exclusionary factors that make a stroke cryptogenic. Restricting PFO closure entirely to patients with high-risk characteristics of the PFO may perhaps be too conservative, but the boundaries of the features that support the procedure are becoming clearer.
Dr. Allan H. Ropper is deputy editor of the New England Journal of Medicine. These comments are taken from an accompanying editorial (). He had no conflicts of interest to declare.
Publish date: October 26, 2015
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