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.

“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.

To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.

Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.

The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.

The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).

SOURCE: Song J. ACC 2018.

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