Patent foramen ovale closure or medical therapy for secondary prevention of cryptogenic stroke: An update meta-analysis of randomized controlled trials

BACKGROUND: It was under debate whether cryptogenic stroke patients benefited from patent foramen ovale (PFO) closure. We sought to determine secondary prevention strategy in these patients. METHODS: Scientific databases were searched for randomized controlled trials enrolling cryptogenic stroke patients with PFO who underwent PFO closure or medical therapy. The random-effect model was used to analyze the outcomes. RESULTS: We identified 6 trials enrolling 3630 participants in this meta-analysis. When compared with medical therapy, PFO closure reduced risks of recurrent stroke (risk ratio [RR] 0.52, 95% confidence interval [CI] 0.29–0.93) and composite of stroke and transient ischemic attack (TIA) (RR 0.60, 95% CI 0.46–0.80). And no differences in all-cause death (RR 0.80, 95% CI 0.37–1.72) and cardiovascular death (RR 1.47, 95% CI 0.36–5.94) between 2 groups were observed. The risks of major bleeding (RR 0.96, 95% CI 0.47–1.96) and any serious adverse event (RR 1.03, 95% CI 0.92–1.16) did not differ between 2 groups. Yet, PFO closure increased risk of atrial fibrillation (RR 4.25, 95% CI 2.10–8.60). CONCLUSION: PFO closure, as compared with medical therapy, was associated with decreased risk of recurrent stroke and increased risk of atrial fibrillation in cryptogenic stroke patients with PFO.