Browsing by Author "Yoon, Byung-Woo"

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    Intracranial and systemic atherosclerosis in the NAVIGATE ESUS trial: Recurrent stroke risk and response to antithrombotic therapy
    (2020) Ameriso, Sebastian F.; Amarenco, Pierre; Pearce, Lesly A; Perera, Kanjana S; Ntaios, George; Lang, Wilfried; Bereczki, Daniel; Uchiyama, Shinichiro; Kasner, Scott E; Yoon, Byung-Woo; Lavados, Pablo; Firstenfeld, Alfredo; Mikulik, Robert; Povedano, Guillermo Pablo; Ferrari, Jorge; Mundl, Hardi; Berkowitz, Scott D.; Connolly, Stuart J.; Hart, Robert G
    Non-stenotic intracranial and systemic atherosclerosis are associated with ischemic stroke. We report frequency and response to anticoagulant vs. antiplatelet prophylaxis of patients with embolic stroke of undetermined source (ESUS) who have non-stenotic intracranial atherosclerosis and/or systemic atherosclerosis. Methods: Exploratory analysis of the international NAVIGATE ESUS randomized trial comparing rivaroxaban 15mg daily with aspirin 100mg daily in 7213 patients with recent ESUS. Among participants with results of intracranial arterial imaging with either computed tomographic angiography (CTA) or magnetic resonance angiography (MRA), the frequency and predictors of non-stenotic intracranial and systemic atherosclerosis and responses to antithrombotic therapy were assessed. Results: Among 4723 participants with available intracranial CTA or MRA results (65% of the trial cohort), the prevalence of intracranial atherosclerosis was 16% (n=739). Patient features independently associated with intracranial atherosclerosis included East Asian region (odds ratio 2.7, 95%CI 2.2,3.3) and cervical carotid plaque (odds ratio 2.3, 95%CI 1.9,2.7), among others. The rate of recurrent ischemic stroke averaged 4.8%/year among those with intracranial atherosclerosis vs. 5.0.%/year for those without (HR 0.95, 95%CI 0.65, 1.4). Among those with intracranial atherosclerosis, the recurrent ischemic stroke rate was higher if assigned to rivaroxaban (5.8%/year) vs. aspirin (3.7%/year), but the difference was not statistically significant (HR 1.6, 95%CI 0.78, 3.3). There was trend for the effect of antithrombotic treatments to be different according to the presence or absence of intracranial atherosclerosis (pinteraction=0.09). Among participants with evidence of systemic atherosclerosis by either history or imaging (n=3820), recurrent ischemic stroke rates were similar among those assigned to rivaroxaban (5.5%/year) vs. aspirin (4.9%/year)(HR 1.1, 95%CI 0.84, 1.5). Conclusions: East Asia region was the strongest factor associated with intracranial atherosclerosis. There were no statistically significant differences between rivaroxaban and aspirin prophylaxis for recurrent ischemic stroke in patien
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    Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial
    (Sage Publications, 2016) Hart, Robert; Sharma, Mukul; Mundl, Hardi; Shoamanesh, Ashkan; Kasner, Scott; Berkowitz, Scott; Pare, Guillaume; Kirsch, Bodo; Pogue, Janice; Pater, Calin; Peters, Gary; Davalos, Antoni; Lang, Wilfried; Wang, Yongjun; Wang, Yilong; Cunha, Luis; Eckstein, Jens; Tatlisumak, Turgut; Shamalov, Nikolay; Mikulik, Robert; Lavados, Pablo; Hankey, Graeme; Czlonkowska, Anna; Toni, Danilo; Ameriso, Sebastian; Gagliardi, Rubens; Amarenco, Pierre; Bereczki, Daniel; Uchiyama, Shinichiro; Lindgren, Arne; Endres, Matthias; Brouns, Raf; Yoon, Byung-Woo; Ntaios, George; Veltkamp, Roland; Muir, Keith; Ozturk, Serefnur; Arauz, Antonio; Bornstein, Natan; Bryer, Alan; O’Donnell, Martin; Weitz, Jeffrey; Peacock, Frank; Themeles, Ellison; Connolly, Stuart
    Background: Embolic strokes of undetermined source comprise up to 20% of ischemic strokes. The stroke recurrence rate is substantial with aspirin, widely used for secondary prevention. The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source international trial will compare the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, versus aspirin for secondary prevention in patients with recent embolic strokes of undetermined source. Main hypothesis: In patients with recent embolic strokes of undetermined source, rivaroxaban 15 mg once daily will reduce the risk of recurrent stroke (both ischemic and hemorrhagic) and systemic embolism (primary efficacy outcome) compared with aspirin 100 mg once daily. Design: Double-blind, randomized trial in patients with embolic strokes of undetermined source, defined as nonlacunar cryptogenic ischemic stroke, enrolled between seven days and six months from the qualifying stroke. The planned sample size of 7000 participants will be recruited from approximately 480 sites in 31 countries between 2014 and 2017 and followed for a mean of about two years until at least 450 primary efficacy outcome events have occurred. The primary safety outcome is major bleeding. Two substudies assess (1) the relative effect of treatments on MRIdetermined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. Summary: The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source trial is evaluating the benefits and risks of rivaroxaban for secondary stroke prevention in embolic strokes of undetermined source patients. Main results are anticipated in 2018.

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