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J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.

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

Author information

1
Department of Neurology, University of Pennsylvania, Philadelphia, United States. Electronic address: kasner@pennmedicine.upenn.edu.
2
Clinica Alemana de Santiago, Universidad del Desarrollo, Universidad de Chile, Santiago, Chile.
3
Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
4
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
5
Departament of Neuroscencies, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
6
Pirogov Russian National Research Medical University, Moscow, Russia.
7
Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
8
Department of Clinical Sciences (Neurology), Department of Neurology and Rehabilitation Medicine, Skane University Hospital, Lund University, Lund, Sweden.
9
International Clinical Research Center and Neurology Department, St. Anne's University Hospital, Brno, Czech Republic.
10
Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico.
11
Hospital St. John of God, Medical Faculty, Sigmund Freud University, Vienna, Austria.
12
2(nd) Department of Neurology, Institute of Psychiatry and Neurology, Medical University of Warsaw, Warsaw, Poland.
13
Department of Innere Medizin, Universitätsspital Basel, Basel, Switzerland.
14
Irmandade da Santa Casa de Misericórdia de São Paulo, Sao Paulo, Brazil.
15
Department of Neurology, Bichat Hospital, Paris, France.
16
Institute for Neurological Research, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, Argentina.
17
Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
18
Imperial College London, London, United Kingdom.
19
School of Medicine and Pharmacology, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia.
20
Department of Neurology and Psychiatry, "Sapienza" University of Rome, Rome, Italy.
21
Department of Neurology, Semmelweis University, Budapest, Hungary.
22
Sanno Hospital and Sanno Medical Center, Tokyo, Japan.
23
Department of Medicine, University of Thessaly, Larissa, Greece.
24
Department of Neurology, Seoul National University Hospital, Seoul, Korea.
25
Universitair Ziekenhuis Brussel, Brussels, Belgium.
26
Tiervlei Trial Centre, Cape Town, South Africa.
27
Klinik und Hochschulambulanz für Neurologie, Center for Stroke Research Berlin, Charité-Universitätsmedizin, Berlin, Germany.
28
Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom.
29
Shaare-Zedek Medical Center, Jerusalem, Israel.
30
Department of Neurology, Selcuk University, Konya, Turkey.
31
National University of Ireland, Galway, Ireland.
32
Bayer Pharma AG, Wuppertal, Germany.
33
Bayer Vital, Leverkusen, Germany.
34
Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada.
35
Baylor College of Medicine, Houston, USA.
36
Population Health Research Institute, Hamilton, Canada.
37
Bayer Pharma AG, Berlin, Germany.
38
Bayer Healthcare Pharmaceuticals, Parsipanny, New Jersey, USA.
39
Janssen Research and Development, LLC, Spring House, United States.
40
Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
41
Department of Medicine (Cardiology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
42
Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.

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.

KEYWORDS:

Embolic Stroke of Undetermined Source (ESUS); Stroke; aspirin; cerebral embolism; cryptogenic stroke; randomized trial; rivaroxaban; stroke prevention

[Indexed for MEDLINE]

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