Rivaroxaban versus aspirin on functional and cognitive outcomes
after embolic stroke of undetermined source: NAVIGATE ESUS
trial

J 2022

Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial

BOSCH, J., L. A. PEARCE, M. SHARMA, M. CANAVAN, W. N. WHITELEY et. al.

Basic information

Original name

Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial

Authors

BOSCH, J. (guarantor), L. A. PEARCE, M. SHARMA, M. CANAVAN, W. N. WHITELEY, Robert MIKULÍK (203 Czech Republic, belonging to the institution), H. MUNDL, S. YUSUF, R. G. HART and M. J. DONNELL

Edition

JOURNAL OF STROKE & CEREBROVASCULAR DISEASES, AMSTERDAM, ELSEVIER SCIENCE BV, 2022, 1052-3057

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30210 Clinical neurology

Country of publisher

Netherlands

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.500

RIV identification code

RIV/00216224:14110/22:00126259

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2022.106404

UT WoS

000795940300027

Keywords in English

Functional; Embolic; ESUS

Abstract

V originále

Background: The effect of interventions on functional impairment is an important outcome in stroke prevention trials and should be considered as an adjunct to counting discrete events. In the NAVIGATE-ESUS trial, 7213 patients with recent embolic strokes of undetermined source were randomized to rivaroxaban (15 mg once daily) or aspirin (100 mg daily). After 11 months there was no effect on the prevention of recurrent stroke. Aims: To determine the effect of rivaroxaban compared to aspirin on functional and cognitive outcomes. Methods: Function and cognition were measured at baseline, 1 year, and study end using the Standard Assessment of Global Everyday Activities (SAGEA), a 15-item scale assessing cognitive, instrumental, and basic activities of daily living as well as mobility, and the Montreal Cognitive Assessment (MoCA). Changes in scores were calculated by subtracting either study end or 1-year scores from baseline, and differences in distributions were compared using the Mann-Whitney U test. SAGEA and MoCA scores were also correlated with recurrent stroke. Results: Follow-up SAGEA scores were available in 6378 (88%) participants. There was no difference in change in function for those allocated to rivaroxaban compared to aspirin (Mann-Whitney U test, p = 0.8), with both distributions having a median (25p,75p) change of 0 (-2,1). Overall, more of those who experienced a recurrent stroke (n=247; mostly minor ischemic), reported functional difficulty at study end versus entry, compared with those who did not (51% versus 30%, chi-square test, p< 0.001), and this was consistent across global regions. There was no difference in the change in cognition by treatment group, nor were recurrent strokes associated with a change in cognition. Conclusions: Rivaroxaban, compared to aspirin, was not associated with changes in functional or cognitive status in patients with recent ESUS. The SAGEA scale detected changes in functional status associated with recurrent strokes in an international stroke population. (c) 2022 Elsevier Inc. All rights reserved.

Citovat

BOSCH, J., L. A. PEARCE, M. SHARMA, M. CANAVAN, W. N. WHITELEY, Robert MIKULÍK, H. MUNDL, S. YUSUF, R. G. HART and M. J. DONNELL. Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial. JOURNAL OF STROKE & CEREBROVASCULAR DISEASES. AMSTERDAM: ELSEVIER SCIENCE BV, 2022, vol. 31, No 5, p. 1-10. ISSN 1052-3057. Available from: https://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2022.106404.

@article{1874643,
   author = {Bosch, J. and Pearce, L. A. and Sharma, M. and Canavan, M. and Whiteley, W. N. and Mikulík, Robert and Mundl, H. and Yusuf, S. and Hart, R. G. and Donnell, M. J.},
   article_location = {AMSTERDAM},
   article_number = {5},
   doi = {http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2022.106404},
   keywords = {Functional; Embolic; ESUS},
   language = {eng},
   issn = {1052-3057},
   journal = {JOURNAL OF STROKE & CEREBROVASCULAR DISEASES},
   title = {Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial},
   url = {https://www.sciencedirect.com/science/article/pii/S105230572200101X?via%3Dihub},
   volume = {31},
   year = {2022}
}

TY  - JOUR
ID  - 1874643
AU  - Bosch, J. - Pearce, L. A. - Sharma, M. - Canavan, M. - Whiteley, W. N. - Mikulík, Robert - Mundl, H. - Yusuf, S. - Hart, R. G. - Donnell, M. J.
PY  - 2022
TI  - Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial
JF  - JOURNAL OF STROKE & CEREBROVASCULAR DISEASES
VL  - 31
IS  - 5
SP  - 1-10
EP  - 1-10
PB  - ELSEVIER SCIENCE BV
SN  - 10523057
KW  - Functional
KW  - Embolic
KW  - ESUS
UR  - https://www.sciencedirect.com/science/article/pii/S105230572200101X?via%3Dihub
N2  - Background: The effect of interventions on functional impairment is an important outcome in stroke prevention trials and should be considered as an adjunct to counting discrete events. In the NAVIGATE-ESUS trial, 7213 patients with recent embolic strokes of undetermined source were randomized to rivaroxaban (15 mg once daily) or aspirin (100 mg daily). After 11 months there was no effect on the prevention of recurrent stroke. Aims: To determine the effect of rivaroxaban compared to aspirin on functional and cognitive outcomes. Methods: Function and cognition were measured at baseline, 1 year, and study end using the Standard Assessment of Global Everyday Activities (SAGEA), a 15-item scale assessing cognitive, instrumental, and basic activities of daily living as well as mobility, and the Montreal Cognitive Assessment (MoCA). Changes in scores were calculated by subtracting either study end or 1-year scores from baseline, and differences in distributions were compared using the Mann-Whitney U test. SAGEA and MoCA scores were also correlated with recurrent stroke. Results: Follow-up SAGEA scores were available in 6378 (88%) participants. There was no difference in change in function for those allocated to rivaroxaban compared to aspirin (Mann-Whitney U test, p = 0.8), with both distributions having a median (25p,75p) change of 0 (-2,1). Overall, more of those who experienced a recurrent stroke (n=247; mostly minor ischemic), reported functional difficulty at study end versus entry, compared with those who did not (51% versus 30%, chi-square test, p< 0.001), and this was consistent across global regions. There was no difference in the change in cognition by treatment group, nor were recurrent strokes associated with a change in cognition. Conclusions: Rivaroxaban, compared to aspirin, was not associated with changes in functional or cognitive status in patients with recent ESUS. The SAGEA scale detected changes in functional status associated with recurrent strokes in an international stroke population. (c) 2022 Elsevier Inc. All rights reserved.
ER  -

BOSCH, J., L. A. PEARCE, M. SHARMA, M. CANAVAN, W. N. WHITELEY, Robert MIKULÍK, H. MUNDL, S. YUSUF, R. G. HART and M. J. DONNELL. Rivaroxaban versus aspirin on functional and cognitive outcomes after embolic stroke of undetermined source: NAVIGATE ESUS trial. \textit{JOURNAL OF STROKE \&{} CEREBROVASCULAR DISEASES}. AMSTERDAM: ELSEVIER SCIENCE BV, 2022, vol.~31, No~5, p.~1-10. ISSN~1052-3057. Available from: https://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2022.106404.

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