Rivaroxaban versus aspirin for prevention of covert brain
infarcts in patients with embolic stroke of undetermined
source: NAVIGATE ESUS MRI substudy

J 2022

Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy

SHARMA, M., E. E. SMITH, L. A. PEARCE, K. S. PERERA, S. E. KASNER et. al.

Basic information

Original name

Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy

Authors

SHARMA, M. (guarantor), E. E. SMITH, L. A. PEARCE, K. S. PERERA, S. E. KASNER, B. W. YOON, S. F. AMERISO, J. PUIG, D. DAMGAARD, J. B. FIEBACH, K. W. MUIR, R. C. VELTKAMP, D. S. TONI, N. SHAMALOV, R. J. GAGLIARDI, Robert MIKULÍK (203 Czech Republic, belonging to the institution), S. T. ENGELTER, D. BERECZKI, M. J. O DONNELL, F. SAAD, A. SHOAMANESH, S. D. BERKOWITZ, H. MUNDL and R. G. HART

Edition

International Journal of Stroke, Hoboken, Wiley-Blackwell, 2022, 1747-4930

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30210 Clinical neurology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 6.700

RIV identification code

RIV/00216224:14110/22:00125086

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/17474930211058012

UT WoS

000721353100001

Keywords in English

Anticoagulation; cerebral microbleeds; covert stroke; embolic stroke; ESUS; randomized clinical trial; rivaroxaban

Abstract

V originále

Background Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. Aims To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. Methods At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. Results Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). Conclusions Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.

Citovat

SHARMA, M., E. E. SMITH, L. A. PEARCE, K. S. PERERA, S. E. KASNER, B. W. YOON, S. F. AMERISO, J. PUIG, D. DAMGAARD, J. B. FIEBACH, K. W. MUIR, R. C. VELTKAMP, D. S. TONI, N. SHAMALOV, R. J. GAGLIARDI, Robert MIKULÍK, S. T. ENGELTER, D. BERECZKI, M. J. O DONNELL, F. SAAD, A. SHOAMANESH, S. D. BERKOWITZ, H. MUNDL and R. G. HART. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. International Journal of Stroke. Hoboken: Wiley-Blackwell, 2022, vol. 17, No 7, p. 799-805. ISSN 1747-4930. Available from: https://dx.doi.org/10.1177/17474930211058012.

@article{1808659,
   author = {Sharma, M. and Smith, E. E. and Pearce, L. A. and Perera, K. S. and Kasner, S. E. and Yoon, B. W. and Ameriso, S. F. and Puig, J. and Damgaard, D. and Fiebach, J. B. and Muir, K. W. and Veltkamp, R. C. and Toni, D. S. and Shamalov, N. and Gagliardi, R. J. and Mikulík, Robert and Engelter, S. T. and Bereczki, D. and O Donnell, M. J. and Saad, F. and Shoamanesh, A. and Berkowitz, S. D. and Mundl, H. and Hart, R. G.},
   article_location = {Hoboken},
   article_number = {7},
   doi = {http://dx.doi.org/10.1177/17474930211058012},
   keywords = {Anticoagulation; cerebral microbleeds; covert stroke; embolic stroke; ESUS; randomized clinical trial; rivaroxaban},
   language = {eng},
   issn = {1747-4930},
   journal = {International Journal of Stroke},
   title = {Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy},
   url = {https://journals.sagepub.com/doi/10.1177/17474930211058012},
   volume = {17},
   year = {2022}
}

TY  - JOUR
ID  - 1808659
AU  - Sharma, M. - Smith, E. E. - Pearce, L. A. - Perera, K. S. - Kasner, S. E. - Yoon, B. W. - Ameriso, S. F. - Puig, J. - Damgaard, D. - Fiebach, J. B. - Muir, K. W. - Veltkamp, R. C. - Toni, D. S. - Shamalov, N. - Gagliardi, R. J. - Mikulík, Robert - Engelter, S. T. - Bereczki, D. - O Donnell, M. J. - Saad, F. - Shoamanesh, A. - Berkowitz, S. D. - Mundl, H. - Hart, R. G.
PY  - 2022
TI  - Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy
JF  - International Journal of Stroke
VL  - 17
IS  - 7
SP  - 799-805
EP  - 799-805
PB  - Wiley-Blackwell
SN  - 17474930
KW  - Anticoagulation
KW  - cerebral microbleeds
KW  - covert stroke
KW  - embolic stroke
KW  - ESUS
KW  - randomized clinical trial
KW  - rivaroxaban
UR  - https://journals.sagepub.com/doi/10.1177/17474930211058012
N2  - Background Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. Aims To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. Methods At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. Results Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). Conclusions Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.
ER  -

SHARMA, M., E. E. SMITH, L. A. PEARCE, K. S. PERERA, S. E. KASNER, B. W. YOON, S. F. AMERISO, J. PUIG, D. DAMGAARD, J. B. FIEBACH, K. W. MUIR, R. C. VELTKAMP, D. S. TONI, N. SHAMALOV, R. J. GAGLIARDI, Robert MIKULÍK, S. T. ENGELTER, D. BERECZKI, M. J. O DONNELL, F. SAAD, A. SHOAMANESH, S. D. BERKOWITZ, H. MUNDL and R. G. HART. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. \textit{International Journal of Stroke}. Hoboken: Wiley-Blackwell, 2022, vol.~17, No~7, p.~799-805. ISSN~1747-4930. Available from: https://dx.doi.org/10.1177/17474930211058012.

Detailed Information on Publication Record