Apixaban vs aspirin in patients with cancer and cryptogenic stroke: a post hoc analysis of the ARCADIA randomized clinical trial Journal Article


Authors: Navi, B. B.; Zhang, C.; Miller, B.; Cushman, M.; Kasner, S. E.; Elkind, M. S. V.; Tirschwell, D. L.; Longstreth, W. T.; Kronmal, R. A.; Beyeler, M.; Elm, J.; Zweifler, R. M.; Tarsia, J.; Cereda, C. W.; Bianco, G.; Costamagna, G.; Michel, P.; Broderick, J. P.; Gladstone, D. J.; Kamel, H.; Streib, C.
Article Title: Apixaban vs aspirin in patients with cancer and cryptogenic stroke: a post hoc analysis of the ARCADIA randomized clinical trial
Abstract: Importance: Approximately 10% to 15% of ischemic strokes are associated with cancer; cancer-associated stroke, particularly when cryptogenic, is associated with high rates of recurrent stroke and major bleeding. Limited data exist on the safety and efficacy of different antithrombotic strategies in patients with cancer and cryptogenic stroke. Objective: To compare apixaban vs aspirin for the prevention of adverse clinical outcomes in patients with history of cancer and cryptogenic stroke. Design, Setting, and Participants: Post hoc analysis of data from 1015 patients with a recent cryptogenic stroke and biomarker evidence of atrial cardiopathy in the Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA) trial, a multicenter, randomized, double-blind clinical trial conducted from 2018 to 2023 at 185 stroke centers in North America. Data analysis was performed from October 15, 2023, to May 23, 2024. Exposures: Oral apixaban, 5 mg (or 2.5 mg if criteria met), twice daily vs oral aspirin, 81 mg, once daily. Subgroups of patients with and without cancer at baseline were examined. Main Outcomes and Measures: The primary outcome for this post hoc analysis was a composite of major ischemic or major hemorrhagic events. Major ischemic events were recurrent ischemic stroke, myocardial infarction, systemic embolism, and symptomatic deep vein thrombosis or pulmonary embolism. Major hemorrhagic events included symptomatic intracranial hemorrhage and any major extracranial hemorrhage. Results: Among 1015 participants (median [IQR] age, 68 [60-76] years; 551 [54.3%] female), 137 (13.5%) had a history of cancer. The median (IQR) follow-up was 1.5 (0.6-2.5) years for patients with history of cancer and 1.5 (0.6-3.0) years for those without history of cancer. Participants with history of cancer, compared with those without history of cancer, had a higher risk of major ischemic or major hemorrhagic events (hazard ratio [HR], 1.73; 95% CI, 1.10-2.71). Among those with history of cancer, 8 of 61 participants (13.1%) randomized to apixaban and 16 of 76 participants (21.1%) randomized to aspirin had a major ischemic or major hemorrhagic event; however, the risk was not significantly different between groups (HR, 0.61; 95% CI, 0.26-1.43). Comparing participants randomized to apixaban vs aspirin among those with cancer, events included recurrent stroke (5 [8.2%] vs 9 [11.8%]), major ischemic events (7 [11.5%] vs 14 [18.4%]), and major hemorrhagic events (1 [1.6%] vs 2 [2.6%]). Conclusions and Relevance: Among participants in the ARCADIA trial with history of cancer, the risk of major ischemic and hemorrhagic events did not differ significantly with apixaban compared with aspirin. Trial Registration: ClinicalTrials.gov Identifier: NCT03192215. © 2024 American Medical Association. All rights reserved.
Keywords: adult; controlled study; aged; middle aged; major clinical study; clinical trial; drug efficacy; cancer patient; comparative study; follow up; neoplasm; neoplasms; bleeding; heart disease; randomized controlled trial; deep vein thrombosis; pyridones; lung embolism; confidence interval; acetylsalicylic acid; pyrazole derivative; heart infarction; multicenter study; stroke; pyrazoles; data analysis; recurrent disease; disease duration; hazard ratio; age distribution; embolism; epidemiology; drug therapy; gender; double blind procedure; double-blind method; brain hemorrhage; secondary prevention; north america; fibrinolytic agent; cerebrovascular accident; fibrinolytic agents; prevention and control; apixaban; etiology; post hoc analysis; medical history; complication; clinical outcome; hemorrhage; aspirin; blood clotting factor 10a inhibitor; ischemic stroke; humans; human; male; female; article; malignant neoplasm; knowledge gap; factor xa inhibitors; dipyrone
Journal Title: JAMA Neurology
Volume: 81
Issue: 9
ISSN: 2168-6149
Publisher: American Medical Association  
Date Published: 2024-09-01
Start Page: 958
End Page: 965
Language: English
DOI: 10.1001/jamaneurol.2024.2404
PUBMED: 39133474
PROVIDER: scopus
PMCID: PMC11320331
DOI/URL:
Notes: Source: Scopus
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  1. Babak Navi
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