Device closure in addition to medical therapy prevented secondary stroke events following cryptogenic stroke in patients with high-risk patent foramen ovale (PFO), according to results of the DEFENSE-PFO trial presented by Jae-Kwan Song, MD, PhD, on Monday, March 12 in a Late-Breaking Clinical Trial session at ACC.18 in Orlando, FL., and simultaneously published in the Journal of the American College of Cardiology.

In the open label DEFENSE-PFO trial, 120 patients with PFO were randomized to receive transcatheter PFO device closure plus medical therapy (n=60) or medical therapy alone (n = 60). High-risk PFO was defined as PFO with atrial septal aneurysm, hypermobility or PFO size ≥2 mm. Medical therapy included anticoagulants or antiplatelet drugs as determined by the patients’ physicians. No direct oral anticoagulants were used in the study. The primary endpoint was a composite of stroke, vascular death or TIMI-defined major bleeding during the two-year follow-up.

Enrollment in the trial was stopped early due to evidence from recent trials of the benefits of PFO device closure for preventing stroke. PFO closure was successful in all 60 patients in the device closure group.

No primary endpoint events occurred in the device closure group during follow-up, compared with six events (2-year event rate, 13.0 percent; standard error, 5.0) in the medical therapy alone group (log-rank p = 0.013). Transient ischemic attack was reported in one patient receiving medical therapy alone. Procedural complications in the device closure group included atrial fibrillation (n=2), pericardial effusion (n=1) and puncture site reaction (n=1).

“We believe that PFO closure should be done in selected patients with cryptogenic stroke and PFO,” Song said. “With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”

According to the investigators, the results suggest that treating 10 PFO patients with device closure would be expected to prevent, on average, about one stroke after two years. Because trials of PFO device closure have been inconsistent in selection of stroke prevention medications, they concluded that additional studies are needed to clarify the potential benefits of different medications when used after stroke in patients with PFO.

Keywords: ACC18, ACC Annual Scientific Session, Heart Defects, Congenital, Ischemic Attack, Transient, Foramen Ovale, Patent, Atrial Fibrillation, Secondary Prevention, Pericardial Effusion, Stroke, Septal Occluder Device, Hemorrhage, Echocardiography, Punctures, Aneurysm

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