ARCADIA (post-hoc analysis)
Trial question
What is the role of apixaban in patients with a history of cancer and cryptogenic stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 137
137 patients (75 female, 62 male).
Inclusion criteria: patients with a history of cancer and cryptogenic stroke.
Key exclusion criteria: AF; clear indication for anticoagulant therapy; clear indication for antiplatelet therapy; history of spontaneous ICH; clinically significant bleeding diathesis; clinically significant gastrointestinal bleeding within 1 year; mRS score of 5.
Interventions
N=61 apixaban (oral dose of 5 mg, or 2.5 mg if criteria met, BID).
N=76 aspirin (oral dose of 81 mg once daily).
Primary outcome
Major ischemic or major hemorrhagic event
13.1%
21.1%
21.1 %
15.8 %
10.6 %
5.3 %
0.0 %
Apixaban
Aspirin
No significant
difference ↔
No significant difference in major ischemic or major hemorrhagic event (13.1% vs. 21.1%; HR 0.61, 95% CI 0.26 to 1.43).
Secondary outcomes
No significant difference in recurrent ischemic stroke (8.2% vs. 9.2%; HR 0.87, 95% CI 0.28 to 2.76).
No significant difference in ischemic or hemorrhagic stroke (8.2% vs. 11.8%; HR 0.68, 95% CI 0.23 to 2.03).
No significant difference in major ischemic event (11.5% vs. 18.4%; HR 0.59, 95% CI 0.24 to 1.47).
Safety outcomes
No significant difference in major hemorrhagic event or death.
Conclusion
In patients with a history of cancer and cryptogenic stroke, apixaban was not superior to aspirin with respect to major ischemic or major hemorrhagic event.
Reference
Babak B Navi, Cenai Zhang, Benjamin Miller et al. Apixaban vs Aspirin in Patients With Cancer and Cryptogenic Stroke: A Post Hoc Analysis of the ARCADIA Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):958-965.
Open reference URL