A1 Refereed original research article in a scientific journal
Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial
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, T. Tatlisumak; on behalf of the NAVIGATE ESUS investigators
Publisher: WILEY
Publication year: 2020
Journal: European Journal of Neurology
Journal name in source: EUROPEAN JOURNAL OF NEUROLOGY
Journal acronym: EUR J NEUROL
Volume: 27
Issue: 5
First page : 841
Last page: 848
Number of pages: 8
ISSN: 1351-5101
eISSN: 1468-1331
DOI: https://doi.org/10.1111/ene.14172
Self-archived copy’s web address: https://helda.helsinki.fi/bitstream/10138/326415/1/Martinez_Majander_et_al_2020_European_Journal_of_Neurology.pdf
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).
