Open AccessRecurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials
Author(s) -
Aakash Garg,
Mohammed Thawabi,
Amit Rout,
Christoph Sossou,
Marc Cohen,
John B. Kostis
Publication year - 2019
Publication title -
cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 63
eISSN - 1421-9751
pISSN - 0008-6312
DOI - 10.1159/000500501
Subject(s) - medicine , patent foramen ovale , randomized controlled trial , meta analysis , stroke (engine) , relative risk , atrial fibrillation , surgery , closure (psychology) , confidence interval , cardiology , migraine , economics , mechanical engineering , engineering , market economy
Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20–0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32–12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16–0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29–1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.