N Martinez-Majander1, G Ntaios2, Y Y Liu3, P Ylikotila4, H Joensuu5, J Saarinen6, K S Perera3, J Marti-Fabregas7, A Chamorro8, S Rudilosso8, L Prats-Sanchez7, S D Berkowitz9, H Mundl10, E Themeles3, M Tiainen1, A Demchuk11, S E Kasner12, R G Hart3, T Tatlisumak13,14. 1. Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland. 2. Department of Internal Medicine, University of Thessaly, Larissa, Greece. 3. Population Health Research Institute, McMaster University, Hamilton, ON, Canada. 4. Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland. 5. Department of Oncology, Helsinki University Hospital, Helsinki, Finland. 6. Department of Neurology, Vaasa Central Hospital, Vaasa, Finland. 7. Department of Neurology, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute, IIB-Sant Pau, Barcelona, Spain. 8. Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic, University of Barcelona, Spain. 9. Bayer U.S., LLC, Whippany, NJ, USA. 10. Bayer Pharma AG, Wuppertal, Germany. 11. Calgary Stroke Program, Departments of Clinical Neuroscience and Radiology and Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. 12. Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. 13. Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden. 14. Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
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. www.clinicaltrials.gov (NCT02313909).
RCT Entities:
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-cancerpatients 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 cancerpatients, 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 cancerpatients, 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 cancerpatients regarding major bleeds. www.clinicaltrials.gov (NCT02313909).
Authors: Hans-Christoph Diener; J Donald Easton; Robert G Hart; Scott Kasner; Hooman Kamel; George Ntaios Journal: Nat Rev Neurol Date: 2022-05-10 Impact factor: 44.711
Authors: Babak B Navi; Scott E Kasner; Mitchell S V Elkind; Mary Cushman; Oh Young Bang; Lisa M DeAngelis Journal: Stroke Date: 2021-01-28 Impact factor: 7.914