Predictors of Recurrent Ischemic Stroke in Patients with Embolic Strokes of Undetermined Source and Effects of Rivaroxaban Versus Aspirin According to Risk Status : The NAVIGATE ESUS Trial
(2019) In Journal of Stroke and Cerebrovascular Diseases 28(8). p.2273-2279- Abstract
Background: Embolic stroke of undetermined source (ESUS) identifies patients with cryptogenic ischemic stroke presumed due to embolism from several unidentified sources. Among patients with recent ESUS, we sought to determine independent predictors of recurrent ischemic stroke during treatment with aspirin or rivaroxaban and to assess the relative effects of these treatments according to risk. Methods: Exploratory analyses of 7213 participants in the NAVIGATE ESUS international trial who were randomized to aspirin 100 mg/day or rivaroxaban 15 mg/day and followed for a median of 11 months, during which time there were 309 first recurrent ischemic strokes (4.6% per year). Baseline features were correlated with recurrent stroke by... (More)
Background: Embolic stroke of undetermined source (ESUS) identifies patients with cryptogenic ischemic stroke presumed due to embolism from several unidentified sources. Among patients with recent ESUS, we sought to determine independent predictors of recurrent ischemic stroke during treatment with aspirin or rivaroxaban and to assess the relative effects of these treatments according to risk. Methods: Exploratory analyses of 7213 participants in the NAVIGATE ESUS international trial who were randomized to aspirin 100 mg/day or rivaroxaban 15 mg/day and followed for a median of 11 months, during which time there were 309 first recurrent ischemic strokes (4.6% per year). Baseline features were correlated with recurrent stroke by multivariate analysis. Results: The 7 independent predictors of recurrent stroke were stroke or transient ischemic attack (TIA) prior to the qualifying stroke (hazard ratio [HR] 2.03 95% confidence internal [CI] 1.58-2.60), current tobacco user (HR 1.62, 95% CI 1.24-2.12), age (HR 1.02 per year increase, 95%CI 1.01-1.03), diabetes (HR 1.28, 95% CI 1.01-1.64), multiple acute infarcts on neuroimaging (HR 1.49, 95% CI 1.09-2.02), aspirin use prior to qualifying stroke (HR 1.34, 95% CI 1.02-1.70), and time from qualifying stroke to randomization (HR .98, 95% CI .97-.99). The rate of recurrent stroke rate was 2.6% per year for participants without any of these risk factors, and increased by an average of 45% for each independent predictor (P < .001). There were no significant interactions between treatment effects and independent stroke predictors or stroke risk status. Conclusions: In this large cohort of ESUS patients, several features including prior stroke or TIA, advanced age, current tobacco user, multiple acute infarcts on neuroimaging, and diabetes independently identified those with an increased risk of ischemic stroke recurrence. The relative effects of rivaroxaban and aspirin were similar across the spectrum of independent stroke predictors and recurrent stroke risk status.
(Less)
- author
- author collaboration
- organization
- publishing date
- 2019-05-31
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Embolic stroke, ESUS, prediction of recurrent stroke, recurrent stroke, rivaroxaban, stroke recurrence
- in
- Journal of Stroke and Cerebrovascular Diseases
- volume
- 28
- issue
- 8
- pages
- 2273 - 2279
- publisher
- Elsevier
- external identifiers
-
- pmid:31160218
- scopus:85066339482
- ISSN
- 1052-3057
- DOI
- 10.1016/j.jstrokecerebrovasdis.2019.05.014
- language
- English
- LU publication?
- yes
- id
- e5eedff4-8ad5-45c0-b00e-34760b6e3dcf
- date added to LUP
- 2019-06-18 08:02:23
- date last changed
- 2024-03-03 13:54:45
@article{e5eedff4-8ad5-45c0-b00e-34760b6e3dcf,
abstract = {{<p>Background: Embolic stroke of undetermined source (ESUS) identifies patients with cryptogenic ischemic stroke presumed due to embolism from several unidentified sources. Among patients with recent ESUS, we sought to determine independent predictors of recurrent ischemic stroke during treatment with aspirin or rivaroxaban and to assess the relative effects of these treatments according to risk. Methods: Exploratory analyses of 7213 participants in the NAVIGATE ESUS international trial who were randomized to aspirin 100 mg/day or rivaroxaban 15 mg/day and followed for a median of 11 months, during which time there were 309 first recurrent ischemic strokes (4.6% per year). Baseline features were correlated with recurrent stroke by multivariate analysis. Results: The 7 independent predictors of recurrent stroke were stroke or transient ischemic attack (TIA) prior to the qualifying stroke (hazard ratio [HR] 2.03 95% confidence internal [CI] 1.58-2.60), current tobacco user (HR 1.62, 95% CI 1.24-2.12), age (HR 1.02 per year increase, 95%CI 1.01-1.03), diabetes (HR 1.28, 95% CI 1.01-1.64), multiple acute infarcts on neuroimaging (HR 1.49, 95% CI 1.09-2.02), aspirin use prior to qualifying stroke (HR 1.34, 95% CI 1.02-1.70), and time from qualifying stroke to randomization (HR .98, 95% CI .97-.99). The rate of recurrent stroke rate was 2.6% per year for participants without any of these risk factors, and increased by an average of 45% for each independent predictor (P < .001). There were no significant interactions between treatment effects and independent stroke predictors or stroke risk status. Conclusions: In this large cohort of ESUS patients, several features including prior stroke or TIA, advanced age, current tobacco user, multiple acute infarcts on neuroimaging, and diabetes independently identified those with an increased risk of ischemic stroke recurrence. The relative effects of rivaroxaban and aspirin were similar across the spectrum of independent stroke predictors and recurrent stroke risk status.</p>}},
author = {{Hart, Robert G. and Veltkamp, Roland C. and Sheridan, Patrick and Sharma, Mukul and Kasner, Scott E. and Bangdiwala, Shrikant I. and Ntaios, George and Shoamanesh, Ashkan and Ameriso, Sebastian F. and Toni, Danilo and Czlonkowska, Anna and Lindgren, Arne and Hankey, Graeme J. and Perera, Kanjana S. and Shuaib, Ashfaq and Coutts, Shelagh B. and Gagliardi, Rubens J. and Berkowitz, Scott D. and Mundl, Hardi and Peters, Gary and Connolly, Stuart J.}},
issn = {{1052-3057}},
keywords = {{Embolic stroke; ESUS; prediction of recurrent stroke; recurrent stroke; rivaroxaban; stroke recurrence}},
language = {{eng}},
month = {{05}},
number = {{8}},
pages = {{2273--2279}},
publisher = {{Elsevier}},
series = {{Journal of Stroke and Cerebrovascular Diseases}},
title = {{Predictors of Recurrent Ischemic Stroke in Patients with Embolic Strokes of Undetermined Source and Effects of Rivaroxaban Versus Aspirin According to Risk Status : The NAVIGATE ESUS Trial}},
url = {{http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.014}},
doi = {{10.1016/j.jstrokecerebrovasdis.2019.05.014}},
volume = {{28}},
year = {{2019}},
}