Efficacy of interventional closure versus drug therapy for patent foramen ovale with cryptogenic stroke

Objective To compare the efficacy of interventional closure versus drug therapy in treatment of patent foramen ovale (PFO) complicated with cryptogenic stroke (CS). Methods Clinical data of 167 patients with cerebral infarction or transient ischemic attack (TIA) complicated with PFO admitted in the Department of Neurology, General Hospital of Ningxia Medical University from January 2015 to August 2019 were collected and analyzed retrospectively. Among them, 80 (the surgery group) underwent PFO interventional closure and antithrombotic drug administration, and the other 87 (the drug group) only received drug therapy (oral antiplatelet aggregation or anticoagulant drugs). All the patients were followed up for an average of 31.6 (12~67) months. According to occurrence of endpoint events (recurrent cerebral infarction, recurrent TIA and death), the patients were divided into endpoint event group (n=24) and non-endpoint event group (n=143). Univariate analysis was used to compare the general data between the 2 groups of patients, and multivariate analysis was used to screen independent risk factors for the recurrence of the endpoint events. Receiver operating characteristic (ROC) curve analysis was combined to evaluate the predictive values of obtained risk factors. Results The recurrence rate of the endpoint events was significantly lower in the surgery group than the drug group (Chi-square=10.959, P=0.001), and the patients with moderate and large shunts of PFO benefited more (Chi-square=10.26, P=0.001). Univariate analysis showed that the treatment method, follow-up time and history of obstructive sleep apnea (OSA) had statistical significances in the occurrence of endpoint events (P < 0.05); Multivariate logistic regression analysis showed that the independent risk factors affecting the prognosis of patients were drug therapy (OR=8.958, P=0.001, 95%CI: 2.475~32.422), follow-up time (OR=1.041, P=0.013, 95%CI: 1.009~1.075) and a history of OSA (OR=8.117, P=0.001, 95%CI: 2.247~29.324). ROC curve analysis showed that the area under the curve was 0.813 (95%CI: 0.737 to 0.889, P < 0.001) for the model with drug therapy, follow-up time, and OSA history as variables. The area under the curve was 0.767 (95%CI: 0.677~0.856, P < 0.001) for the model with drug therapy and OSA history as variables, and 0.764 (95%CI: 0.674~0.853, P < 0.001) for the model with drug therapy and follow-up time as variables. Conclusion For patients with PFO complicated with CS, interventional closure can reduce the risk of recurrence of the end point events, and the patients with moderate or large number of shunts of PFO benefit more. Active OSA intervention have a certain preventive effect on the recurrence of the endpoint events.