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The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. We conducted a systematic review and meta-analysis with trial sequential analysis (TSA) of randomized trials. Primary outcomes are stroke or transient ischemic attack (TIA) and all-cause mortality. Secondary outcomes are peripheral embolism, bleeding, serious adverse events, myocardial infarction and atrial dysrhythmias. We performed an intention to treat meta-analysis with a random-effects model. We include six trials (3677 patients, mean age 47.3 years, 55.8% men). PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.38-0.81; I 2  = 40%]. The TSA confirms this result. No difference is found in mortality (RR 0.74, 95% CI 0.35-1.60; I 2  = 0%), while PFO closure is associated with a higher incidence of atrial dysrhythmias (RR 4.55, 95% CI 2.16-9.60; I 2  = 25%). The rate of the other outcomes is not different among the two groups. The comparison between anticoagulant and antiplatelet therapy shows no difference in terms of stroke recurrence, mortality and bleeding. There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.

Syncope is the common clinical manifestation of different diseases, and this makes it difficult to define what outcomes should be considered in prognostic studies. The aim of this study is to critically analyze the outcomes considered in syncope studies through systematic review and expert consensus. We performed a systematic review of the literature to identify prospective studies enrolling consecutive patients presenting to the Emergency Department with syncope, with data on the characteristics and incidence of short-term outcomes. Then, the strengths and weaknesses of each outcome were discussed by international syncope experts to provide practical advice to improve future selection and assessment. 31 studies met our inclusion criteria. There is a high heterogeneity in both outcome choice and incidence between the included studies. The most commonly considered 7-day outcomes are mortality, dysrhythmias, myocardial infarction, stroke, and rehospitalisation. The most commonly considered 30-day outcomes are mortality, haemorrhage requiring blood transfusion, dysrhythmias, myocardial infarction, pacemaker or implantable defibrillator implantation, stroke, pulmonary embolism, and syncope relapse. We present a critical analysis of the pros and cons of the commonly considered outcomes, and provide possible solutions to improve their choice in ED syncope studies. We also support global initiatives to promote the standardization of patient management and data collection.

The optimal target of blood pressure (BP) in the acute phase of intracranial haemorrhage (ICH) is still controversial. Our aim was to evaluate safety and efficacy of intensive BP lowering compared to standard BP treatment in ICH. We conducted a systematic review and meta-analysis of all available randomized controlled trials recruiting patients with elevated BP in acute spontaneous ICH to intensive or standard BP-lowering treatment. Our primary outcomes were 3-month mortality, disability (modified Rankin Scale 3-5) and combined death or disability. Secondary outcomes were early neurological deterioration at 24 h, substantial haematoma enlargement within 24-72 h and 3-month non-fatal serious adverse events. We included six studies for a total of 4385 patients (mean age 62 years, 62.3% men). No differences were detected between the two treatment groups in 3-month mortality (RR = 0.99, 95% CI 0.83-1.17), disability (RR = 0.96, 95% CI 0.89-1.03) and combined death and disability (RR = 0.97, 95% CI 0.90-1.03). The rate of patients with early neurological deterioration, substantial haematoma enlargement and non-fatal serious adverse events was similar in the two treatment groups (RR = 1.03, 95% CI 0.88-1.19, RR = 0.85, 95% CI 0.70-1.03, RR = 1.07, 95% CI 0.90-1.28, respectively). An intensive BP control in the acute phase of ICH is not beneficial and should not be recommended. Therefore, the systolic BP target of less than 140 mmHg that is now suggested by guidelines needs to be reconsidered.