Abstract
BACKGROUND: The optimal duration of antithrombotic therapy (ATT) after patent foramen ovale (PFO) closure remains under debate. This study sought to compare the clinical outcome of patients receiving antithrombotic agents for a short (6 months) versus extended (>6 months) period after the procedure. METHODS: This was a retrospective cohort study using a propensity score matching analysis on 259 consecutive patients (131 males, 43 ± 10 years) undergoing PFO closure due to cryptogenic stroke, with complete follow-up (median duration of 10 [4-13] years). The outcome was compared between patients receiving short-term (Group short, N = 88) versus extended ATT (Group long, N = 171). RESULTS: The PFO closure device was successfully implanted in all cases, with 3% of minor complications. After propensity score matching, there were no differences between Groups short and long in the rate of stroke (0.3 vs. 0.4% patient-year, p=1.00), bleeding (2 vs. 2% patient-year, p=0.17), and device thrombosis (0.3 vs. 0.1% patient-year; p=0.60). Univariate analysis showed that short-term ATT was not associated with an increased risk of recurrent stroke (HR: 1.271 [95% CI: 0.247-6.551], p=0.775) or prosthesis thrombus (HR: 0.50 [95% CI: 0.070-3.548], p=0.72). Kaplan-Meier analysis revealed similar overall survival in Group short and long (100 vs. 99 ± 1%, respectively; p=0.25). CONCLUSIONS: Short-term (6 months) ATT after PFO closure did not impair the clinical outcome, with a preserved low rate of recurrent stroke (0.3% patient-year) and device thrombosis (0.2% patient-year) at 10-year follow-up.