Article Synopsis
- Embolic strokes of undetermined source account for 20% of ischemic strokes and have a high recurrence rate; the study compared rivaroxaban, an oral anticoagulant, against aspirin for preventing these recurrences.
- In a trial with 7213 participants, rivaroxaban did not show significant benefits over aspirin in preventing recurrent strokes, with similar rates of recurrence observed in both treatment groups.
- However, patients taking rivaroxaban experienced a substantially higher rate of major bleeding compared to those on aspirin, leading to the conclusion that rivaroxaban is not a better option for preventing recurrent strokes in this patient population.
Video Abstracts
Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin.
Methods: We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding.
Results: A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001).
Conclusions: Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding. (Funded by Bayer and Janssen Research and Development; NAVIGATE ESUS ClinicalTrials.gov number, NCT02313909 .).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1056/NEJMoa1802686 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial.
JAMA
September 2025
Division of Surgery and Interventional Science, UCL, London, United Kingdom.
Importance: Multiparametric magnetic resonance imaging (MRI), with or without prostate biopsy, has become the standard of care for diagnosing clinically significant prostate cancer. Resource capacity limits widespread adoption. Biparametric MRI, which omits the gadolinium contrast sequence, is a shorter and cheaper alternative offering time-saving capacity gains for health systems globally.
View Article and Find Full Text PDFUsing Medication Dispensation Data to Identify Clusters with Similar Prescribing Patterns in Older Adults Living with Dementia.
Drugs Aging
September 2025
Dalla Lana School of Public Health, University of Toronto, V1 06, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.
Background And Objectives: Older adults living with dementia are a heterogeneous group, which can make studying optimal medication management challenging. Unsupervised machine learning is a group of computing methods that rely on unlabeled data-that is, where the algorithm itself is discovering patterns without the need for researchers to label the data with a known outcome. These methods may help us to better understand complex prescribing patterns in this population.
View Article and Find Full Text PDFChatGPT-4o is Not a Reliable Study Source for Orthopaedic Surgery Residents.
JB JS Open Access
September 2025
Department of Orthopaedic Surgery, St. Luke's University Health Network, Bethlehem, Pennsylvania.
Background: The use of artificial intelligence platforms by medical residents as an educational resource is increasing. Within orthopaedic surgery, older Chat Generative Pre-trained Transformer (ChatGPT) models performed worse than resident physicians on practice examinations and rarely answered questions with images correctly. The newer ChatGPT-4o was designed to improve these deficiencies but has not been evaluated.
View Article and Find Full Text PDFBrain network signatures of spatial memory in adolescents at risk for substance use.
Alcohol Clin Exp Res (Hoboken)
September 2025
Neurodevelopmental Laboratory on Addictions and Mental Health, McLean Hospital, Belmont, Massachusetts, USA.
Background: Examining youth before engagement in risky behaviors may help identify neurobiological signatures that prospectively predict susceptibility to initiating and escalating alcohol and other substance use. Given that frontal and medial temporal (e.g.
View Article and Find Full Text PDFLong-term oral glucocorticoid use is associated with complications, healthcare resource utilization, and costs among patients with dermatomyositis or polymyositis.
Clin Rheumatol
September 2025
Immunology Market Access, Johnson & Johnson, Horsham, PA, USA.
Introduction/objective: Oral glucocorticoids (OGC) are conventionally used as first-line treatment for dermatomyositis (DM) and polymyositis (PM). This study evaluated clinical and economic outcomes associated with long-term (LT) OGC use in DM/PM.
Methods: Adults with ≥ 2 medical claims of DM/PM 30‒365 days apart from January 1, 2016, to December 31, 2022, and ≥ 1 diagnosis code of a physician specialty of interest were selected from the MarketScan Commercial and Medicare Supplemental databases.