Studies have finally confirmed that closure of the patent foramen ovale can prevent recurrent strokes, but the procedure may also have the added benefit of alleviating migraines in certain patients.
“Everybody in the field has been impressed with the fact that about half of patients with stroke and PFO have migraines and that when we close the PFO to prevent another stroke, a large majority of patients tell us that their migraines are better and occur less frequently,” Jonathan M. Tobis, MD, MSCAI, professor of medicine and interventional cardiology at the UCLA David Geffen School of Medicine, told Cardiology Today’s Intervention.
The PREMIUM trial conducted by Tobis and colleagues, which was published in the Journal of the American College of Cardiology in 2017, was a double-blind study investigating migraine characteristics during 1 year in patients randomly assigned PFO closure with the Amplatzer PFO Occluder or medical therapy plus a sham procedure.
The results were somewhat disappointing in that there was no difference between the intervention and control arms in responder rate, defined as a 50% reduction in migraine attacks and adverse events. However, patients in the PFO closure group experienced a significant reduction in headache days compared with the control group and complete migraine remission occurred in 8.5% of the intervention group vs. 1% of the control group (P = .01).
“There is anecdotal evidence that PFO closure reduces, and occasionally eliminates, the burden of migraine, but it’s been very challenging to identify who would respond to this and who would not,” John D. Carroll, MD, professor of medicine and director of interventional cardiology at the University of Colorado School of Medicine, said. “This is an area that’s very ripe for a well-designed clinical trial learning from the past trials that have not delivered the kind of definitive information we really need.”
- Tobis JM, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2017.09.1105.
Disclosure: This study was funded by St. Jude Medical. Carroll reports he has served on the steering committee of the RESPECT trial and he has received compensation for services related to that role from the study sponsors (AGA Medical, St. Jude Medical and Abbott Vascular). Tobis reports he serves on the PREMIUM steering committee and he is a proctor for Abbott Vascular and W.L. Gore and Associates. Please see the study for all other authors’ relevant financial disclosures.
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