Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials

Abstract

Background: Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis.

Methods: Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).

Results: Five trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19-0.90; p = 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36-0.80; p = 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51-1.14; p = 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09-10.70; p < 0.00001). Mortality (OR 0.80, CI 0.39-1.67), major bleeding (OR 0.96, CI 0.48-1.92), and VTE (OR 2.45, CI 0.75-7.99) remained neutral. Trials with superior patient selection for PFO-C showed advantageous results compared to MT.

Conclusions: PFO-C after cryptogenic ischemic stroke is safe and effective to reduce the risk of recurrent stroke and recurrent stroke + TIA, albeit with an increased risk for NOAF.

Keywords: Closure; Cryptogenic stroke; Occluder; PFO; Patent foramen ovale.