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

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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. / Messé, 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.

In: Stroke, Vol. 52, No. 11, 2021, p. 3419-3426.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Messé, SR, Erus, G, Bilello, M, Davatzikos, C, Andersen, G, Iversen, HK, Roine, RO, Sjöstrand, C, Rhodes, JF, Søndergaard, L & Kasner, SE 2021, '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', Stroke, vol. 52, no. 11, pp. 3419-3426. https://doi.org/10.1161/STROKEAHA.121.034451

APA

Messé, S. R., Erus, G., Bilello, M., Davatzikos, C., Andersen, G., Iversen, H. K., Roine, R. O., Sjöstrand, C., Rhodes, J. F., Søndergaard, L., & Kasner, S. E. (2021). 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. Stroke, 52(11), 3419-3426. https://doi.org/10.1161/STROKEAHA.121.034451

Vancouver

Messé SR, Erus G, Bilello M, Davatzikos C, Andersen G, Iversen HK et al. 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. Stroke. 2021;52(11):3419-3426. https://doi.org/10.1161/STROKEAHA.121.034451

Author

Messé, 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. / 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. In: Stroke. 2021 ; Vol. 52, No. 11. pp. 3419-3426.

Bibtex

@article{6ee4bfbb639b42338ab10f70831b1822,
title = "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",
abstract = "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.",
author = "Mess{\'e}, {Steven R.} and Guray Erus and Michel Bilello and Christos Davatzikos and Grethe Andersen and Iversen, {Helle K.} and Roine, {Risto O.} and Christina Sj{\"o}strand and Rhodes, {John F.} and Lars S{\o}ndergaard and Kasner, {Scott E.}",
note = "Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",
year = "2021",
doi = "10.1161/STROKEAHA.121.034451",
language = "English",
volume = "52",
pages = "3419--3426",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams & Wilkins",
number = "11",

}

RIS

TY - JOUR

T1 - Patent Foramen Ovale Closure Decreases the Incidence but Not the Size of New Brain Infarction on Magnetic Resonance Imaging

T2 - An Analysis of the REDUCE Trial

AU - Messé, Steven R.

AU - Erus, Guray

AU - Bilello, Michel

AU - Davatzikos, Christos

AU - Andersen, Grethe

AU - Iversen, Helle K.

AU - Roine, Risto O.

AU - Sjöstrand, Christina

AU - Rhodes, John F.

AU - Søndergaard, Lars

AU - Kasner, Scott E.

N1 - Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85118857457&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.121.034451

DO - 10.1161/STROKEAHA.121.034451

M3 - Journal article

C2 - 34455822

AN - SCOPUS:85118857457

VL - 52

SP - 3419

EP - 3426

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 11

ER -

ID: 305118182