ObjectiveWe aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial.IntroductionThe clinical benefit of closing a PFO has been an open question, so it is necessary to review the current state of published medical data in regards to this subject.MethodsMEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were used to search for randomized controlled trials (RCTs) that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Six studies fulfilled our eligibility criteria and included 3560 patients (1889 for PFO closure and 1671 for medical therapy.ResultsThe risk ration (RR) for stroke in the “closure” group compared with the “medical therapy” showed a statistically significant difference between the groups, favouring the “closure” group (RR 0.366; 95%CI 0.171–0.782, P=0.010). There was no statistically significant difference between the groups regarding the safety outcomes, death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the “closure” group (RR 4.131; 95%CI 2.293–7.443, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke.ConclusionThis meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of hypertension, atrial septal aneurysm and effective closure. The publication of a new trial did not change the scenario in the medical literature.