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

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