Efficacy and safety of percutaneous patent foramen ovale closure devices for recurrent stroke: A systemic review and network metaanalysis

Abstract

Background: Randomized controlled trials (RCTs) that directly compare the efficacy and safety of percutaneous patent foramen ovale (PFO) closure devices have not been conducted. Thus, we performed a network meta-analysis to identify the efficacy and safety of occluder devices. Methods: From 1st January, 2000 to 1st May, 2018, we searched Embase, PubMed, and Cochrane Library for RCTs about percutaneous closure devices (such as STARFlex, GORE, and Amplatzer) and medical therapy for cryptogenic cerebral ischemic patients with PFO. The occurrence rate of recurrent stroke, atrial fibrillation (AF), major vascular complication (MVC), headache, transient ischemic attack, and bleeding were compared with the frequentist and Bayesian methods using R statistics. Results: We included 3747 patients from six RCTs. The GORE and Amplatzer occluders were found to be significantly associated with a decreased risk of recurrent stroke [relative risk (RR): 0.37 and 0.49; 95% confidence interval (CI): 0.17–0.81, 0.29–0.83, respectively]. Moreover, STARFlex was correlated to an increased risk of postoperative AF and MVCs (RR: 11.66 and 7.63; 95% CI: 4.87–21.91, 2.34–24.88). Conclusions: Among the three devices, the GORE and Amplatzer occluders are found to be the most effective in preventing secondary stroke in patients with PFO. Meanwhile, STARFlex is the least recommended device because it cannot decrease the risk of recurrent stroke and is the most likely to cause adverse events.