Conclusions The results of our meta-analysis show a favorable trend towards transcatheter closure of PFO as compared to medical therapy in intention-to-treat analysis and confirm a benefit in per-protocol analysis, despite the fact that many patients who would have truly benefited from device closure may have not been randomized in these trials, but underwent off-label closure.
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Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials.
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Despite ambiguity regarding patient selection, less than optimum patient enrollment, and inadequate follow up, our meta-analyses which combined data from the three RCTs showed a trend towards superiority of PFO closure as compared to medical therapy, and statistically significant benefit of PFO closure in the per protocol population.