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BIBTEX RIS

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

2018; Elsevier BV; Volume: 27; Issue: 6 Linguagem: Inglês

10.1016/j.jstrokecerebrovasdis.2018.01.027

1532-8511

Scott E. Kasner, Pablo M. Lavados, Mukul Sharma, Yongjun Wang, Yilong Wang, Antoni Dávalos, N. А. Shamalov, Luís Cunha, Cecilia M. Lindgren, Robert Mikulík, Antonio Araúz, Wilfried Lang, Anna Członkowska, Jens Eckstein, Rubens José Gagliardi, Pierre Amarenco, Sebastián F. Ameriso, Turgut Tatlisumak, Roland Veltkamp, Graeme J. Hankey, Danilo Toni, Dániel Bereczki, Shinichiro Uchiyama, George Ntaios, Byung‐Woo Yoon, Raf Brouns, M.M. DeVries Basson, Matthias Endres, Keith W. Muir, Natan M. Bornstein, Şerefnur Öztürk, Martin O’Donnell, Hardi Mundl, C. Pater, Jeffrey I. Weitz, W. Frank Peacock, Balakumar Swaminathan, Bodo Kirsch, Scott D. Berkowitz, Gary Peters, Guillaume Paré, Ellison Themeles, Ashkan Shoamanesh, Stuart J. Connolly, Robert G. Hart,

Venous Thromboembolism Diagnosis and Management

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. 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. We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. 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. 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. 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.