Apixaban, Aspirin Similar for Patients With Cancer History, Cryptogenic Stroke

Among patients with recent cryptogenic stroke and history of cancer taking apixaban vs aspirin, the risk for major ischemic and hemorrhagic events is not significantly different, according to study results published in JAMA Neurology.

To compare the 2 medications, researchers conducted a post-hoc subgroup analysis of the Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA; ClinicalTrials.gov Identifier: NCT03192215) randomized clinical trial. The double-blind trial was conducted from 2018 to 2023, with a primary outcome of major ischemic or major hemorrhagic events.

The cohort consisted 1015 participants (median age, 69; women, 54.3%) who had biomarkers for atrial cardiopathy, history of cancer, and prior cryptogenic stroke. Patients were excluded for the presence of atrial fibrillation, clear indication for antiplatelet or anticoagulant therapy, history of spontaneous intracranial hemorrhage, serum creatinine of 2.5mg/dL or higher, clinically significant bleeding, platelet count less than 100 x 10³/μL, or a modified Rankin Scale score of 5.

Participants were randomized in a 1:1 ratio to receive active apixaban and placebo aspirin or active aspirin and placebo apixaban. Apixaban was given in a dose of 5 mg orally twice daily or 2.5 mg orally twice daily based on standard dosing for each patient. Aspirin was given in a dose of 81 mg orally once daily. Of the 137 patients (median age, 74; women, 54.7%; White, 86.9%) with cancer included, 76 were randomized to receive aspirin and 61 were randomized to receive apixaban. Median follow-up time was 1.5 (0.6-2.5) years.

Among participants with cancer, the incidence rate for major ischemic or hemorrhagic events was 10.6 (95% CI, 7.1-15.8) per 100 person-years compared to 5.9 (95% CI, 4.8-7.3) per 100 person-years in 878 ARCADIA participants without cancer.

Major ischemic or hemorrhagic events were experienced by 8 of the 61 participants (13.1%) receiving apixaban (incidence rate, 7.8 [95% CI, 3.9-15.7] per 100 person-years) and 16 of the 76 participants (21.1%) receiving aspirin (incidence rate, 12.8 [95% CI, 7.8-20.9] per 100 person-years). No significant difference was found between the groups (HR, 0.61; 95% CI, 0.26-1.43; P =.26).

The events recorded in the apixaban group vs the aspirin group consisted of recurrent stroke (8.2% vs 11.8%, respectively), major ischemic events (11.5% vs 18.4%, respectively), and major hemorrhagic events (1.6% vs 2.6%, respectively).

Study limitations included the lack of data on cancer type, stage, treatment, and diagnosis date, an underpowered subgroup analysis, the presence of additional patient biomarker evidence for atrial cardiopathy which could modify treatment effects, and potential lack generalizability to other anticoagulant doses than the doses utilized.

“The results should be considered hypothesis generating and do not answer the question about whether anticoagulant therapy benefits patients with cryptogenic stroke and history of cancer,” the researchers wrote.

Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.