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

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...

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Bibliographic Details
Published in:Clinical research in cardiology 2018-09, Vol.107 (9), p.745-755
Main Authors: Schulze, Volker, Lin, Yingfeng, Karathanos, Athanasios, Brockmeyer, Maximilian, Zeus, Tobias, Polzin, Amin, Perings, Stefan, Kelm, Malte, Wolff, Georg
Format: Article
Language:English
Subjects:
Bleeding
Cardiology
Clinical trials
Confidence intervals
Data processing
Fibrillation
Flutter
Health risk assessment
Health risks
Ischemia
Medicine
Medicine & Public Health
Meta-analysis
Mortality
Original Paper
Prevention
Randomization
Stroke
Therapy
Thromboembolism
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Summary: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  
ISSN:1861-0684
1861-0692
DOI:10.1007/s00392-018-1224-4