Secondary prevention after cryptogenic cerebrovascular events in patients with patent foramen ovale

Patients with patent foramen ovale and cryptogenic stroke are at risk of recurrence, but there are few data on strategies to prevent this.

We studied 280 consecutive patients with cryptogenic cerebrovascular events and a patent foramen ovale examined by multiplane transesophageal echocardiography. Patients received platelet inhibitors (n = 66) or anticoagulation (n = 47) or underwent device closure (n = 167). During the mean follow-up of 2.6 years, we compared the frequency of recurrent events, death and severe treatment complications.

A total of 33 (12%) patients had a recurrent cerebrovascular event. The annual recurrence rates were 13% in patients treated with platelet inhibitors, 5.6% in those on oral anticoagulation, and 0.6% in those after device closure. Independent predictors of recurrent cerebrovascular events were a patent foramen ovale larger than 4 mm (hazard ratio 3.8, 95% CI 1.2-11.2; p = 0.017) or previous strokes (hazard ratio 4.3, 95% CI 2.0-9.2; p < 0.001). Interventional closure of the patent foramen ovale decreased the risk of a recurrent event compared with oral anticoagulation (hazard ratio 0.06, 95% CI 0.12-0.29; p < 0.001), whereas antiplatelet therapy showed a trend to an increased risk (hazard ratio 2.3; 95% CI 0.9-5.5; p = 0.055). Major side effects occurred in 7 anticoagulated patients and in 13 patients after device closure. There were two non-vascular deaths and one fatal hemorrhagic stroke.

Patients with a large patent foramen ovale and a cryptogenic cerebrovascular event had a substantial risk of recurrence even with medical treatment. Risk of recurrence was lower after device closure of the patent foramen ovale.