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.