Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Effects of Semaglutide on Stroke Subtypes in Type 2 Diabetes: Post Hoc Analysis of the Randomized SUSTAIN 6 and PIONEER 6

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Age At Menopause: A Female Risk Factor of Stroke?

    Publikation: Bidrag til tidsskriftLederForskningpeer review

  4. Early Brain Injury and Soluble ST2 After Nontraumatic Subarachnoid Hemorrhage

    Publikation: Bidrag til tidsskriftLetterForskningpeer review

  1. Striving for Perfection in Transcatheter LAA Closure: One Step Closer With Newer-Generation Devices

    Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

  2. Facilitation techniques to cross the interatrial septum with intracardiac echocardiography during left atrial appendage closure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Comparison of Predicted and Confirmed Neo-Left Ventricular Outflow Tract After Transcatheter Mitral Valve Replacement

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Is transcatheter aortic valve implantation safe in patients with left ventricular outflow tract calcification?

    Publikation: Bidrag til tidsskriftLederForskningpeer review

  • Steven R Messé
  • Guray Erus
  • Michel Bilello
  • Christos Davatzikos
  • Grethe Andersen
  • Helle K Iversen
  • Risto O Roine
  • Christina Sjöstrand
  • John F Rhodes
  • Lars Søndergaard
  • Scott E Kasner
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftStroke
Vol/bind52
Udgave nummer11
Sider (fra-til)3419-3426
Antal sider8
ISSN0039-2499
DOI
StatusUdgivet - nov. 2021

ID: 67851118