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Patients who had had a cryptogenic stroke and had a PFO were randomly assigned to medical therapy or PFO closure. At a median of 5.9 years, the rate of recurrent ischemic strokes was lower in the PFO closure group than in the medical-therapy group.

In a randomized trial involving 664 patients who had had a cryptogenic stroke, closure of a PFO combined with antiplatelet therapy resulted in significantly lower rates of subsequent stroke than antiplatelet therapy alone over a median follow-up of 3.2 years.

In patients with cryptogenic stroke and patent foramen ovale with atrial septal aneurysm or large interatrial shunt, closure of the PFO and administration of antiplatelet medications resulted in a lower rate of recurrent stroke than antiplatelet therapy alone.

In this study, closure of a patent foramen ovale versus medical therapy alone after cryptogenic stroke was not effective in preventing recurrent stroke. Secondary analyses suggested a possible benefit, but the study did not permit a definitive conclusion. It is unknown whether closure of a patent foramen ovale is effective in the prevention of recurrent stroke after a cryptogenic ischemic stroke. Observational studies and meta-analyses have suggested that closure is associated with a benefit; however, a randomized trial, Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale (CLOSURE I), failed to show the superiority of closure over medical therapy alone. 1 – 3 In observational studies, the Amplatzer PFO Occluder has been shown to have advantageous safety features as a closure device. 4 – . . .

In this trial, patients with patent foramen ovale and cryptogenic embolism were assigned to undergo closure with the use of a percutaneous device or to receive medical therapy. There was no significant difference in the rates of recurrent embolic events or death. Paradoxical embolism by means of a patent foramen ovale has been blamed as a cause of stroke and other systemic ischemic events since the 19th century. 1 The actual passage of a venous clot through a patent foramen ovale has been documented in a few cases and resulted in systemic embolic events such as ischemic stroke, transient ischemic attack (TIA), 2 – 6 or myocardial infarction. 7 Catheter-based closure of patent foramen ovale was introduced in 1992. 8 Observational long-term data suggest that closure of patent foramen ovale in patients with a history of ischemic stroke may reduce the risk of recurrent stroke as compared . . .

Patients with a cryptogenic stroke or transient ischemic attack (TIA) who had a patent foramen ovale were randomly assigned to closure with a percutaneous device or to medical therapy. There was no significant between-group difference in the subsequent rate of stroke or TIA. As many as 40% of acute ischemic strokes have no identifiable cause and are classified as cryptogenic. 1 – 3 Some cryptogenic strokes or transient ischemic attacks (TIAs) may be the result of an embolus from the venous system traversing from the right to left atrium and into the systemic circulation through a patent foramen ovale — a phenomenon known as paradoxical embolism. Numerous studies have shown an association between patent foramen ovale and cryptogenic stroke. 4 – 14 The prevalence of patent foramen ovale at autopsy ranges from 20 to 26% in the general population, and it may be as high as 56% . . .

Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22–1·36), and the risk was similar for those without known PFO (1·06; 0·84–1·33; pinteraction=0·18). The risks of major bleeding with rivaroxaban versus aspirin were similar in patients with PFO detected (HR 2·05; 95% CI 0·51–8·18) and in those without PFO detected (HR 2·82; 95% CI 1·69–4·70; pinteraction=0·68). The random-effects meta-analysis combined data from NAVIGATE ESUS with data from two previous trials (PICSS and CLOSE) and yielded a summary odds ratio of 0·48 (95% CI 0·24–0·96; p=0·04) for ischaemic stroke in favour of anticoagulation, without evidence of heterogeneity. Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted. Bayer and Janssen.

Previous studies have examined the impact of antithrombotic agents on Patent Foramen Ovale (PFO) in relation to migraine. However, differences in effectiveness of different antithrombotic agents and traditional migraine medications are not known. This study is an investigator-initiated, randomized, multicenter, single-masked (outcomes assessor), and active-controlled parallel-group trial (ClinicalTrials.gov Identifier: NCT05546320), with the objective of evaluating the prevention efficacy of antithrombotic agents compared to first-line migraine medication in PFO patients. The trial involves 1,000 migraine patients with a right-to-left shunt at the atrial level, randomized in a 1:1:1:1 fashion to receive either aspirin 300 mg QD, clopidogrel 75 mg QD, rivaroxaban 20 mg QD, or the active-control metoprolol 25 mg BID. The primary efficacy end point is the response rate, defined as a 50% or greater reduction in the average migraine attack days per month or in the average number of migraine attacks per month at 12-week visit compared to baseline. The COMPETE trial aims to provide valuable insights into the comparative effectiveness of antithrombotic agents and standard migraine therapies in patients with PFO. This study holds the promise of advancing treatment approaches for individuals having migraines associated with PFO, thus addressing an important gap in current migraine management strategies.

Medical treatment for stroke prevention in cryptogenic stroke (CS) patients with patent foramen ovale (PFO) remains inconclusive. We compared the efficacy and safety of dabigatran with aspirin on stroke prevention for patients with recent CS and PFO. In this prospective cohort study, we randomly assigned patients with PFO who had a cryptogenic stroke, in a 1:1 ratio, to dabigatran or aspirin group. Patients were followed for 2 years and the primary efficacy outcome was the recurrence of stroke or systemic embolism. The primary safety outcome was occurrence of bleeding complications. A total of 375 patients were enrolled in the study, 188 assigned to the dabigatran group and 187 to the aspirin group. During the 2-year follow-up, the primary efficacy outcomes occurred in 4 patients in the dabigatran group (annualized rate, 2.0%) and 11 patients in the aspirin group (annualized rate, 5.1%) (hazard ratio, 0.74; 95% confidence interval, 0.51–0.98; P = 0.049). TIA/acute ischemic stroke occurred in 3 patients in the dabigatran group and 8 patients in the aspirin group (hazard ratio, 0.72; 95% confidence interval, 0.52–0.95; P = 0.039). Bleeding complications occurred in 8 patients in the dabigatran group (annualized rate, 3.9%) and in 7 patients in the aspirin group (annualized rate, 3.5%) (hazard ratio, 1.24; 95% confidence interval, 1.01–1.52; P = 0.886). For cryptogenic stroke with PFO, dabigatran was superior to aspirin for stroke prevention. There is no increased risk of bleeding complication with dabigatran. •Dabigatran better lowered the reoccurrence of TIA/stroke and systemic embolism for patients with cryptogenic stroke and patent foramen ovale.•There no differences on the cardiovascular events between dabigatran group and aspirin group.•As compared to aspirin, dabigatran did not increase the risk of bleeding complications in the population.

ObjectiveThis study aimed to investigate the effectiveness of risk scoring for predicting stroke recurrence after percutaneous patent foramen ovale (PFO) closure or medication therapy in patients with PFO and a history of cryptogenic stroke.MethodsThis study included 559 patients with PFO and cryptogenic stroke who were treated in our hospital from January 2013 to January 2018 and were followed up for 15–72 months. After calculating the risk scores for stroke recurrence, we randomly divided the patients into two groups (ratio, 1:1): Patients in one group underwent PFO closure and those in the other received drug therapy.ResultsPatients in the PFO closure group had a lower risk of recurrent stroke than those in the drug therapy group (1.1% vs. 4.2%). Moreover, serious bleeding was less frequent in the PFO closure group than in the drug therapy group (0% vs. 3.2%), although the incidence of atrial fibrillation or flutter did not significantly differ between the groups (p = 0.67). Interestingly, a subgroup analysis revealed no inter-treatment group difference in the rate of cryptogenic stroke recurrence among patients with risk scores of 0–1. By contrast, PFO closure yielded superior outcomes among patients with risk scores of ≥2.ConclusionCompared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.