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

Abstract

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.

• Authors: Scott E Kasner, Pablo Lavados, Mukul Sharma, Yongjun Wang, Yilong Wang, Antoni Dávalos, Nikolay Shamalov, Luis Cunha, Arne Lindgren, Robert Mikulik, Antonio Arauz, Wilfried Lang, Anna Czlonkowska, Jens Eckstein, Rubens Gagliardi, Pierre Amarenco, Sebastián F Ameriso, Turgut Tatlisumak, Roland Veltkamp, Graeme J Hankey, Danilo S Toni, Daniel Bereczki, Shinichiro Uchiyama, George Ntaios, Byung-Woo Yoon, Raf Brouns, M M DeVries Basson, Matthias Endres, Keith Muir, Natan Bornstein, Serefnur Ozturk, Martin O'Donnell, Hardi Mundl, Calin Pater, Jeffrey Weitz, W Frank Peacock, Balakumar Swaminathan, Bodo Kirsch, Scott D Berkowitz, Gary Peters, Guillaume Pare, Ellison Themeles, Ashkan Shoamanesh, Stuart J Connolly, Robert G Hart, NAVIGATE ESUS Steering Committee and Investigators
• Journal: Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association (J Stroke Cerebrovasc Dis) Vol. 27 Issue 6 Pg. 1673-1682 (Jun 2018) ISSN: 1532-8511 [Electronic] United States
• PMID: 29525076 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Chemical References

• Factor Xa Inhibitors
• Fibrinolytic Agents
• Platelet Aggregation Inhibitors
• Rivaroxaban
• Aspirin

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Aspirin (therapeutic use)
• Comorbidity
• Double-Blind Method
• Factor Xa Inhibitors (therapeutic use)
• Female
• Fibrinolytic Agents (therapeutic use)
• Humans
• Intracranial Embolism (diagnosis, drug therapy, epidemiology)
• Ischemic Attack, Transient (diagnosis, drug therapy, epidemiology)
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (therapeutic use)
• Racial Groups
• Risk Factors
• Rivaroxaban (therapeutic use)
• Sex Factors
• Stroke (diagnosis, drug therapy, epidemiology)
• Treatment Outcome