TY - JOUR
T1 - Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial
AU - NAVIGATE ESUS Steering Committee and Investigators
AU - Kasner, Scott E.
AU - Lavados, Pablo
AU - Sharma, Mukul
AU - Wang, Yongjun
AU - Wang, Yilong
AU - Dávalos, Antoni
AU - Shamalov, Nikolay
AU - Cunha, Luis
AU - Lindgren, Arne
AU - Mikulik, Robert
AU - Arauz, Antonio
AU - Lang, Wilfried
AU - Czlonkowska, Anna
AU - Eckstein, Jens
AU - Gagliardi, Rubens
AU - Amarenco, Pierre
AU - Ameriso, Sebastián F.
AU - Tatlisumak, Turgut
AU - Veltkamp, Roland
AU - Hankey, Graeme J.
AU - Toni, Danilo S.
AU - Bereczki, Daniel
AU - Uchiyama, Shinichiro
AU - Ntaios, George
AU - Yoon, Byung Woo
AU - Brouns, Raf
AU - DeVries Basson, M. M.
AU - Endres, Matthias
AU - Muir, Keith
AU - Bornstein, Natan
AU - Ozturk, Serefnur
AU - O'Donnell, Martin
AU - Mundl, Hardi
AU - Pater, Calin
AU - Weitz, Jeffrey
AU - Peacock, W. Frank
AU - Swaminathan, Balakumar
AU - Kirsch, Bodo
AU - Berkowitz, Scott D.
AU - Peters, Gary
AU - Pare, Guillaume
AU - Themeles, Ellison
AU - Shoamanesh, Ashkan
AU - Connolly, Stuart J.
AU - Hart, Robert G.
N1 - Publisher Copyright:
© 2018 National Stroke Association
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
KW - Embolic Stroke of Undetermined Source (ESUS)
KW - Stroke
KW - aspirin
KW - cerebral embolism
KW - cryptogenic stroke
KW - randomized trial
KW - rivaroxaban
KW - stroke prevention
UR - http://www.scopus.com/inward/record.url?scp=85042946778&partnerID=8YFLogxK
U2 - 10.1016/j.jstrokecerebrovasdis.2018.01.027
DO - 10.1016/j.jstrokecerebrovasdis.2018.01.027
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AN - SCOPUS:85042946778
SN - 1052-3057
VL - 27
SP - 1673
EP - 1682
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
IS - 6
ER -