Abstract

Background: Hypercoagulability due to thrombophilia may increase the risk of paradoxic embolism. However, previous randomized controlled trials that evaluated the efficacy of PFO closure or medical therapy on the risk of recurrent stroke and/or transient ischemic attack (TIA) events, have excluded these potentially high-risk thrombophilia patients. In this study, we want to investigate the effect of PFO management on the risks of recurrent stroke and/or TIA among patients with thrombophilia. Methods: Patients with a PFO attributable ischemic stroke or TIA are prospectively recruited. Hypercoagulable tests for protein C, protein S, antithrombin III, homocysteine levels, IgG and IgM anticardiolipin antibodies, factor V Leiden and prothrombin gene variant were obtained. The primary outcome was occurrence of stroke and/or TIA after index event. Results: Thrombophilia is diagnosed in 120 PFO stroke patients who subsequently underwent PFO closure (n= 76) vs medical therapy (n= 44) ( Table 1 ). The mean duration of follow-up was 45 months in the closure group and 40 months in the medical-therapy group. The primary end point occurred in 5 patients (6.6%) in the closure group and in 14 (31.8%) in the medical therapy group (hazard ratio for medical therapy vs. closure, 5.797; 95% confidence interval [CI], 2.094 to 16.051; P = 0.001) ( Figure 1 ) with recurrent rate of 18.2% vs. 5.3% for TIA (P = 0.023) and 13.6% vs. 1.3% for stroke (P = 0.018) respectively. Conclusions: PFO stroke patients with hypercoagulable state had higher rate of recurrent stroke than those patients in clinical trials. Among patients who had cryptogenic embolism with thrombophilia, closure of a PFO was associated with a lower rate of recurrent stroke and/or TIA than medical therapy.

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