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Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial

Kasner, Scott E. ; Lavados, Pablo ; Sharma, Mukul ; Wang, Yongjun ; Wang, Yilong ; Dávalos, Antoni ; Shamalov, Nikolay ; Cunha, Luis ; Lindgren, Arne LU and Mikulik, Robert , et al. (2018) In Journal of Stroke and Cerebrovascular Diseases 27(6). p.1673-1682
Abstract

Background: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. Aims: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. Methods: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. Results: Mean age was 66.9 ± 9.8 years; 24% were... (More)

Background: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. Aims: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. Methods: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. Results: Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. Conclusions: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Aspirin, Cerebral embolism, Cryptogenic stroke, Embolic Stroke of Undetermined Source (ESUS), Randomized trial, Rivaroxaban, Stroke, Stroke prevention
in
Journal of Stroke and Cerebrovascular Diseases
volume
27
issue
6
pages
1673 - 1682
publisher
Elsevier
external identifiers
  • pmid:29525076
  • scopus:85042946778
ISSN
1052-3057
DOI
10.1016/j.jstrokecerebrovasdis.2018.01.027
language
English
LU publication?
yes
id
71d903dd-cf03-45d1-9aa4-2c0e6eecfe0e
date added to LUP
2018-03-23 11:58:33
date last changed
2025-04-15 15:03:02
@article{71d903dd-cf03-45d1-9aa4-2c0e6eecfe0e,
  abstract     = {{<p>Background: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. Aims: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. Methods: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. Results: Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. Conclusions: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.</p>}},
  author       = {{Kasner, Scott E. and Lavados, Pablo and Sharma, Mukul and Wang, Yongjun and Wang, Yilong and Dávalos, Antoni and Shamalov, Nikolay and Cunha, Luis and Lindgren, Arne and Mikulik, Robert and Arauz, Antonio and Lang, Wilfried and Czlonkowska, Anna and Eckstein, Jens and Gagliardi, Rubens and Amarenco, Pierre and Ameriso, Sebastián F. and Tatlisumak, Turgut and Veltkamp, Roland and Hankey, Graeme J. and Toni, Danilo S. and Bereczki, Daniel and Uchiyama, Shinichiro and Ntaios, George and Yoon, Byung Woo and Brouns, Raf and DeVries Basson, M. M. and Endres, Matthias and Muir, Keith and Bornstein, Natan and Ozturk, Serefnur and O'Donnell, Martin and Mundl, Hardi and Pater, Calin and Weitz, Jeffrey and Peacock, W. Frank and Swaminathan, Balakumar and Kirsch, Bodo and Berkowitz, Scott D. and Peters, Gary and Pare, Guillaume and Themeles, Ellison and Shoamanesh, Ashkan and Connolly, Stuart J. and Hart, Robert G.}},
  issn         = {{1052-3057}},
  keywords     = {{Aspirin; Cerebral embolism; Cryptogenic stroke; Embolic Stroke of Undetermined Source (ESUS); Randomized trial; Rivaroxaban; Stroke; Stroke prevention}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{1673--1682}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Stroke and Cerebrovascular Diseases}},
  title        = {{Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial}},
  url          = {{http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2018.01.027}},
  doi          = {{10.1016/j.jstrokecerebrovasdis.2018.01.027}},
  volume       = {{27}},
  year         = {{2018}},
}