PHILADELPHIA — The results of two long-awaited clinical trials, testing a closure device versus medication to prevent stroke recurrence in young stroke survivors who have an opening in the atrial wall, have not provided enough evidence to conclude who, if anyone, is likely to benefit from the interventional procedure, according to an accompanying editorial in the New England Journal of Medicine co-authored by a Perelman School of Medicine researcher at the University of Pennsylvania.
Young survivors of stroke are more likely to have a patent foramen ovale (PFO), an opening in the wall between upper chambers of the heart that is found in about one quarter of the population. This opening can allow a small clot to pass through the heart, which can result in a stroke. Neither of the two studies published in the New England Journal definitively showed that using a device to close the PFO was more effective at preventing a secondary stroke than medications to prevent clots.
In the editorial, co-authored by Steven Messe, MD, assistant professor of Neurology at the Perelman School of Medicine, the authors note that, "given the prevalence of patent foramen ovale in the general population, the enormous potential for overuse of percutaneous closure of a patent foramen ovale, and the relatively low risk of stroke in patients who are treated medically, the routine use of this therapy seems unwise without a clearer view of who, if anyone, is likely to benefit."
David Kent, MD, from Tufts University, co-authored the editorial with Dr. Messe. The editorial is online at the New England Journal of Medicine, as are the results from the two clinical trials, RESPECT and PC Trial.
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