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Initial trials of patent foramen ovale (PFO) closure devices for cryptogenic stroke failed to consistently demonstrate clear superiority to medical management, but two recent clinical trials have challenged this notion (NEJM JW Neurol Nov 2017 and N Engl J Med 2017; 377:1011 and 1033). Two systematic reviews and meta-analyses have now synthesized this new evidence together with data from previously reported trials. The search strategy for both reviews ultimately identified the same four clinical trials totaling 2892 patients for the final analysis: PC-Trial, RESPECT, REDUCE, and CLOSE. Both reviews excluded the CLOSURE-I study because the device used in that study is no longer available due to high complication rates.
Shah and colleagues rep…