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

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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. / NAVIGATE ESUS Investigators; Hart, Robert G.; Veltkamp, Roland C.; Sheridan, Patrick; Sharma, Mukul; Kasner, Scott E.; Bangdiwala, Shrikant I.; Ntaios, George; Shoamanesh, Ashkan; Ameriso, Sebastian F.; Toni, Danilo; Czlonkowska, Anna; Lindgren, Arne; Hankey, Graeme J.; Perera, Kanjana S.; Shuaib, Ashfaq; Coutts, Shelagh B.; Gagliardi, Rubens J.; Berkowitz, Scott D.; Mundl, Hardi; Peters, Gary; Connolly, Stuart J.

In: Journal of Stroke and Cerebrovascular Diseases, 31.05.2019.

Research output: Contribution to journalArticle

Harvard

NAVIGATE ESUS Investigators, Hart, RG, Veltkamp, RC, Sheridan, P, Sharma, M, Kasner, SE, Bangdiwala, SI, Ntaios, G, Shoamanesh, A, Ameriso, SF, Toni, D, Czlonkowska, A, Lindgren, A, Hankey, GJ, Perera, KS, Shuaib, A, Coutts, SB, Gagliardi, RJ, Berkowitz, SD, Mundl, H, Peters, G & Connolly, SJ 2019, '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', Journal of Stroke and Cerebrovascular Diseases. https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.014

APA

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NAVIGATE ESUS Investigators, Hart RG, Veltkamp RC, Sheridan P, Sharma M, Kasner SE, Bangdiwala SI, Ntaios G, Shoamanesh A, Ameriso SF, Toni D, Czlonkowska A, Lindgren A, Hankey GJ, Perera KS, Shuaib A, Coutts SB, Gagliardi RJ, Berkowitz SD, Mundl H, Peters G, Connolly SJ. 2019. 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. Journal of Stroke and Cerebrovascular Diseases. https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.014

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NAVIGATE ESUS Investigators ; Hart, Robert G. ; Veltkamp, Roland C. ; Sheridan, Patrick ; Sharma, Mukul ; Kasner, Scott E. ; Bangdiwala, Shrikant I. ; Ntaios, George ; Shoamanesh, Ashkan ; Ameriso, Sebastian F. ; Toni, Danilo ; Czlonkowska, Anna ; Lindgren, Arne ; Hankey, Graeme J. ; Perera, Kanjana S. ; Shuaib, Ashfaq ; Coutts, Shelagh B. ; Gagliardi, Rubens J. ; Berkowitz, Scott D. ; Mundl, Hardi ; Peters, Gary ; Connolly, Stuart J. / 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. In: Journal of Stroke and Cerebrovascular Diseases. 2019.

RIS

TY - JOUR

T1 - Predictors of Recurrent Ischemic Stroke in Patients with Embolic Strokes of Undetermined Source and Effects of Rivaroxaban Versus Aspirin According to Risk Status

T2 - Journal of Stroke & Cerebrovascular Diseases

AU - NAVIGATE ESUS Investigators

AU - Hart, Robert G.

AU - Veltkamp, Roland C.

AU - Sheridan, Patrick

AU - Sharma, Mukul

AU - Kasner, Scott E.

AU - Bangdiwala, Shrikant I.

AU - Ntaios, George

AU - Shoamanesh, Ashkan

AU - Ameriso, Sebastian F.

AU - Toni, Danilo

AU - Czlonkowska, Anna

AU - Lindgren, Arne

AU - Hankey, Graeme J.

AU - Perera, Kanjana S.

AU - Shuaib, Ashfaq

AU - Coutts, Shelagh B.

AU - Gagliardi, Rubens J.

AU - Berkowitz, Scott D.

AU - Mundl, Hardi

AU - Peters, Gary

AU - Connolly, Stuart J.

PY - 2019/5/31

Y1 - 2019/5/31

N2 - 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.

AB - 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.

KW - Embolic stroke

KW - ESUS

KW - prediction of recurrent stroke

KW - recurrent stroke

KW - rivaroxaban

KW - stroke recurrence

U2 - 10.1016/j.jstrokecerebrovasdis.2019.05.014

DO - 10.1016/j.jstrokecerebrovasdis.2019.05.014

M3 - Article

JO - Journal of Stroke & Cerebrovascular Diseases

JF - Journal of Stroke & Cerebrovascular Diseases

SN - 1532-8511

ER -