(HealthDay News) – Closure of a patent foramen ovale does not reduce the risk of recurrent stroke compared with antiplatelet treatment alone in patients who present with a cryptogenic stroke or transient ischemic attack (TIA).
Anthony J. Furlan, MD, from University Hospitals Case Medical Center in Cleveland, and colleagues randomized 909 patients (18–60 years old) with cryptogenic stroke or TIA and a patent foramen ovale to closure with a percutaneous device plus antiplatelet treatment or antiplatelet treatment alone. The primary end point was a composite of stroke or TIA during two years of follow-up, any-cause death during the first 30 days, or neurologic-cause death between 31 days and two years.
The researchers found that, compared with the medical therapy group, the closure group had a nonsignificant reduction in the risk for the primary end point (5.5 and 6.8%, respectively; P=0.37). The corresponding rates for stroke were 2.9 and 3.1%, respectively (P=0.79), and the corresponding rates for TIA were 3.1 and 4.1%, respectively (P=0.44). There were no deaths from neurologic causes during this period, and paradoxical embolism was usually not the cause of recurrent neurologic events. There were no deaths by 30 days in either group.
“In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA,” Furlan and colleagues conclude.
The study was funded by NMT Medical, the manufacturer of the STARFlex device used in the study; several authors disclosed financial relationships with pharmaceutical and medical device companies, including NMT.