Volker Schulze1, Yingfeng Lin1, Athanasios Karathanos1, Maximilian Brockmeyer1, Tobias Zeus1, Amin Polzin1, Stefan Perings1, Malte Kelm1,2, Georg Wolff3. 1. Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany. 2. Cardiovascular Research Institute Düsseldorf (CARID), Düsseldorf, Germany. 3. Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Moorenstr. 5, 40225, Düsseldorf, Germany. georg.wolff@med.uni-duesseldorf.de.
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.
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.
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