A1 Refereed original research article in a scientific journal
Patent Foramen Ovale Closure Decreases the Incidence but Not the Size of New Brain Infarction on Magnetic Resonance Imaging An Analysis of the REDUCE Trial
Authors: Messe Steven R, Erus Guray, Bilello Michel, Davatzikos Christos, Andersen Grethe, Iversen Helle K, Roine Risto O, Sjöstrand Christina, Rhodes John F, Søndergaard Lars, Kasner Scott E; on behalf of the Gore REDUCE Study Investigators
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Publication year: 2021
Journal: Stroke
Journal name in source: STROKE
Journal acronym: STROKE
Volume: 52
Issue: 11
First page : 3419
Last page: 3426
Number of pages: 8
ISSN: 0039-2499
eISSN: 0039-2499
DOI: https://doi.org/10.1161/STROKEAHA.121.034451
Web address : https://www.ahajournals.org/doi/10.1161/STROKEAHA.121.034451
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/68086761
Background and Purpose:
Randomized patent foramen ovale closure trials have used open-label end point ascertainment which increases the risk of bias and undermines confidence in the conclusions. The Gore REDUCE trial prospectively performed baseline and follow-up magnetic resonance imaging (MRIs) for all subjects providing an objective measure of the effectiveness of closure.
Methods:
We performed blinded evaluations of the presence, location, and volume of new infarct on diffusion-weighted imaging of recurrent clinical stroke or new infarct (>3 mm) on T2/fluid attenuated inversion recovery from baseline to follow-up MRI at 2 years, comparing closure to medical therapy alone. We also examined the effect of shunt size and the development of atrial fibrillation on infarct burden at follow-up.
Results:
At follow-up, new clinical stroke or silent MRI infarct occurred in 18/383 (4.7%) patients who underwent closure and 19/177 (10.7%) medication-only patients (relative risk, 0.44 [95% CI, 0.24-0.81], P=0.02). Clinical strokes were less common in closure patients compared with medically treated patients, 5 (1.3%) versus 12 (6.8%), P=0.001, while silent MRI infarcts were similar, 13 (3.4%) versus 7 (4.0%), P=0.81. There were no differences in number, volumes, and distribution of new infarct comparing closure patients to those treated with medication alone. There were also no differences of number, volumes, and distribution comparing silent infarcts to clinical strokes. Infarct burden was also similar for patients who developed atrial fibrillation and for those with large shunts.Conclusions: The REDUCE trial demonstrates that patent foramen ovale closure prevents recurrent brain infarction based on the objective outcome of new infarcts on MRI. Only clinical strokes were reduced by closure while silent infarctions were similar between study arms, and there were no differences in infarct volume or location comparing silent infarcts to clinical strokes.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00738894.
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