ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.