A new trial suggested patients exhibiting patent foramen ovale (PFO), who received a medical device to close the opening in the heart after a stroke, had better outcomes compared to patients who received only stroke-preventing medications. Results of the trial were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando on March 12.

The trial enrolled 120 patients at two centers in South Korea and all patients participating had recently experienced a cryptogenic stroke and had a “high-risk” PFO. Either the PFO was two millimeters across or larger, or along with the PFO, there was tissue protruding into a heart chamber.

All patients received traditional medications (anticoagulants and antiplatelets) recommended by physicians after a stroke to reduce the formation of blood clots or the potential for another stroke. Each patient’s physician determined the type of medication administered, though no direct oral anticoagulants were used. Half of the patients were randomly assigned to receive a PFO closure device which was implanted in the heart by threading the device through a vein in the patient’s groin.

The researchers followed the patients for two years to analyze outcomes. The trial’s endpoint was a composite of stroke, major bleeding events and death from vascular causes.

There were no negative endpoint outcomes in the patients who received the closure device; however, six of the patients who received medication alone had strokes and one patient had a transient ischemic attack. Researchers determined treating 10 patients with PFOs using a closure device could potentially prevent about one stroke after two years.

"Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure," said lead author Jae Kwan Song, MD, Asan Medical Center in Seoul, South Korea and colleagues. "Our study showed that the potential benefit from closure can be determined on the basis of the size of the PFO and the movement of the heart wall around the PFO."