Apixaban, aspirin comparable for patients with cancer history, cryptogenic stroke
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Key takeaways:
- Apixaban and aspirin offered comparable protection against major ischemic or hemorrhagic event for those with cancer history and cryptogenic stroke.
- More research is needed to determine the optional strategy.
Apixaban and aspirin offered similar protection against major ischemic and hemorrhagic events among people with cancer history and cryptogenic stroke.
However, those who received apixaban (Eliquis, Bristol Myers Squibb) had lower incidence of venous thromboembolism and recurrent stroke.
“I was not surprised by our findings,” Babak B. Navi, MD, MS, associate professor and chief of stroke and hospital neurology at Weill Cornell Medicine, told Healio. “Our analysis confirms that there is equipoise regarding the optimal antithrombotic strategy for patients with history of cancer and cryptogenic stroke, and that phase 3 randomized controlled trials are needed to definitively determine whether these patients should be treated with anticoagulant or antiplatelet therapy.”
Background and methods
An estimated 10% to 15% of individuals with ischemic stroke have a cancer history, and about half of those occur among patients with active cancer, according to study background.
Clinicians are unable to determine the cause of stroke in 50% of that subpopulation.
Both anticoagulants and antiplatelet agents could benefit this group, but anticoagulant therapy also has a 20% annual risk for major bleeding for patients with cancer.
“Cancer-related stroke is a growing subgroup of ischemic stroke, and it is associated with perhaps the highest rate of stroke recurrence and poor outcomes among all stroke subgroups,” Navi told Healio. “Further, there is considerable controversy regarding the best blood-thinning strategy for these patients, with limited high-quality data to guide practice.”
Navi and colleagues conducted a post hoc analysis of the randomized ARCADIA trial to investigate the optimal approach to care.
Trial participants had to be at least 45 years with cryptogenic stroke and biomarker evidence for atrial cardiopathy.
ARCADIA researchers randomly assigned patients 1:1 to apixaban or aspirin. The cohort included 1,015 participants (median age, 68 years; 54.3% women), Including 137 individuals (median age, 74 years; 54.7% women; 86.9% white) with cancer history.
The composite of major ischemic or major hemorrhagic events served as the primary endpoint of the post hoc analysis. Secondary endpoints included incidence of recurrent ischemic stroke, ischemic or hemorrhagic stroke, any major arterial ischemic event, symptomatic venous thromboembolism and any major ischemic event, and safety outcomes.
Navi and colleagues defined major ischemic events as myocardial infarction, recurrent ischemic stroke, symptomatic deep vein thrombosis or pulmonary embolism, or systemic embolism.
They defined major hemorrhagic events as any major extracranial hemorrhage or any symptomatic intracranial hemorrhage per ARCADIA trial criteria.
Results and next steps
After median follow-up of 1.5 years, results showed a significantly higher risk for major ischemic or hemorrhagic events among trial participants with cancer history (HR = 1.73; 95% CI, 1.1-2.71).
In the cancer history subgroup, results showed lower incidence of major ischemic or hemorrhagic events with apixaban (13.1% vs. 21.1%); However, the difference did not reach statistical significance (HR = 0.61; 95% CI, 0.26-1.43).
The apixaban cohort had fewer recurrent strokes (8.2% vs. 11.8%), major ischemic events (11.5% vs. 18.4%) and major hemorrhagic events (1.6% vs. 2.6%).
The apixaban group had a higher all-cause mortality rate at 1 year (3.8% vs. 3.1%).
“I think the nominal nonsignificant benefit with apixaban is encouraging and great pilot data for a definitive trial on this topic,” Navi said.
Researchers acknowledged study limitations, including the small sample size and the lack of data on cancer characteristics, including type, severity and treatments.
“The next steps are a phase 3 trial of apixaban vs. aspirin [for] patients with active cancer and cryptogenic stroke,” Navi said. “Future studies should also look at combined anticoagulant and antiplatelet therapy for these patients, as translational data suggest that both the coagulation cascade and platelets play important roles in the pathogenesis of cancer-related cryptogenic stroke. However, patients with cancer and cryptogenic stroke are also at a very high risk for bleeding, and such a combined approach would likely increase bleeding risk even more, which could offset any potential benefits in reducing the risk for ischemic events.”
For more information:
Babak B. Navi, MD, MS, can be reached at ban9003@med.cornell.edu.
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