Antithrombotic therapy versus patent foramen ovale closure for PFO-associated stroke

Four randomized clinical trials have affirmed the superiority of percutaneous PFO closure over medical therapy for secondary prevention of PFO-associated stroke [2–5]. [...]authors of the REDUCE trial recently published 5-year outcomes data, with the number needed to treat to prevent one stroke in 5 years being as low as 25 patients, regardless of PFO/shunt size or presence/absence of an atrial septal aneurysm [6]. [...]a therapeutic efficacy has yet to be observed even with the strongest available anticoagulant, not to mention an annual bleeding risk of 2–4 % with anticoagulation that increases with age. [...]six randomized trials have shown an excellent safety profile with percutaneous PFO closure; all trials showed no difference in incidence of serious adverse events, including incidence of deaths, vascular complications or major bleeding, when device closure was compared to medical therapy [9]. [...]a randomized clinical trial is performed that directly compares the efficacy and safety of oral anticoagulation versus percutaneous device closure for PFO-associated stroke, PFO closure should be considered the safest and most effective treatment to lower risk of recurrent stroke, in accordance with evidence-based randomized data [2–6,19–21].