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Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial

Journal article
Authors N. Martinez-Majander
G. Ntaios
Y. Y. Liu
P. Ylikotila
H. Joensuu
J. Saarinen
K. S. Perera
J. Marti-Fabregas
A. Chamorro
S. Rudilosso
L. Prats-Sanchez
S. D. Berkowitz
H. Mundl
E. Themeles
M. Tiainen
A. Demchuk
S. E. Kasner
R. G. Hart
Turgut Tatlisumak
Published in European Journal of Neurology
Volume 27
Issue 5
Pages 841-848
ISSN 1351-5101
Publication year 2020
Published at Institute of Neuroscience and Physiology, Department of Clinical Neuroscience
Pages 841-848
Language en
Links dx.doi.org/10.1111/ene.14172
Keywords aspirin, cancer, ESUS, ischaemic stroke, NAVIGATE ESUS, rivaroxaban, undetermined source, embolic strokes, Neurosciences & Neurology
Subject categories Neurosciences

Abstract

Background and purpose Cancer is a frequent finding in ischaemic stroke patients. The frequency of cancer amongst participants in the NAVIGATE ESUS randomized trial and the distribution of outcome events during treatment with aspirin and rivaroxaban were investigated. Methods Trial participation required a recent embolic stroke of undetermined source. Patients' history of cancer was recorded at the time of study entry. During a mean follow-up of 11 months, the effects of aspirin and rivaroxaban treatment on recurrent ischaemic stroke, major bleeding and all-cause mortality were compared between patients with cancer and patients without cancer. Results Amongst 7213 randomized patients, 543 (7.5%) had cancer. Of all patients, 3609 were randomized to rivaroxaban [254 (7.0%) with cancer] and 3604 patients to aspirin [289 (8.0%) with cancer]. The annual rate of recurrent ischaemic stroke was 4.5% in non-cancer patients in the rivaroxaban arm and 4.6% in the aspirin arm [hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.78-1.24]. In cancer patients, the rate of recurrent ischaemic stroke was 7.7% in the rivaroxaban arm and 5.4% in the aspirin arm (HR 1.43, 95% CI 0.71-2.87). Amongst cancer patients, the annual rate of major bleeds was non-significantly higher for rivaroxaban than aspirin (2.9% vs. 1.1%; HR 2.57, 95% CI 0.67-9.96; P for interaction 0.95). All-cause mortality was similar in both groups. Conclusions Our exploratory analyses show that patients with embolic stroke of undetermined source and a history of cancer had similar rates of recurrent ischaemic strokes and all-cause mortality during aspirin and rivaroxaban treatments and that aspirin appeared safer than rivaroxaban in cancer patients regarding major bleeds. (NCT02313909).

Page Manager: Webmaster|Last update: 9/11/2012
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