A Meta-analysis Of The Efficacy And Safety Of Closure And Medcial Therapy In Patent Foramen Ovale With Cryptogenic Stroke

Background and objective: Compared with stroke with definite cause,patent foramen ovale is more common in patients with cryptogenic stroke(unknown cause stroke).The treatment of cryptogenic stroke is still a difficult problem today,and it has been controversial that taking closure of patent foramen ovale or medical therapy alone.The purpose of this study was to systematically evaluate the efficacy and safety of closure and medical therapy in patients having patent foramen ovale with cryptogenic stroke.Methods: Clinical trials on the efficacy of foramen ovale occlusion and medical therapy in the treatment of cryptogenic stroke were included.In this study,the outcome events of these experiments were defined as all-cause death,transient ischemic attack,ischemic stroke,peripheral vascular embolism and pulmonary embolism,and the main adverse events were defined as atrial fibrillation and/or atrial flutter and bleeding events.Results: A total of 6 articles were included,with a total of 3750 patients,1889 were treated with patent foramen ovale clousre and 1861 were treated with medical threapy(anti-platelet aggregation and/or anticoagulation therapy).The median follow-up time ranged from 2.0-5.9 years.In terms of the outcomes events,patients who received patent foramen ovale closure had a lower risk of recurrent ischemic stroke(RR 0.49,95% CI 0.35-0.67).In terms of the adverse events,patients who received patent foramen ovale closure a higher risk of atrial fibrillation and / or atrial flutter(RR 5.07,95% CI 2.49-10.30).The risk of allcause death(RR 0.81,95% CI 0.39-1.6),transient ischemic attacks(RR 0.79,95%CI,0.54-1.16),peripheral vascular embolism or pulmonary embolism(RR 1.72,95% CI,0.44-6.7),bleeding events(RR 0.78,95%CI 0.48-1.26)are comparable between two treatments.Subgroup analysis suggested that compared with medical therapy,PFO closure reduce the risk of recurrent ischemic stroke in men(RR 0.48,95% CI 0.28-0.80,P<0.01),those age ≤ 45 years(RR 0.37,95% CI 0.18-0.78,P<0.01),patients with large shunt patent foramen ovale(RR 0.21,95% CI 0.07-0.61,P<;0.01)more significantly.Conclusion: In the treatment of patent foramen ovale related cryptogenic stroke,compared with medical therapy,patent foramen ovale closure can reduce the incidence of ischemic stroke,but also increase the risk of atrial fibrillation and/or atrial flutter.As a treatment of patent foramen ovale with cryptogenic stroke,closure can be added to the clinical decision-making of related diseases.