ARES (aspirin BID vs. aspirin OD)
Trial question
What is the role of higher daily dose of aspirin in patients with high-risk essential thrombocythemia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 165
165 patients (89 female, 76 male)
Inclusion criteria: patients with essential thrombocythemia who are chronically on once-daily low-dose aspirin
Key exclusion criteria: platelet count > 1,000,000/µL before enrollment; diabetes; creatinine level > 1.5× the ULN; liver disease; active gastrointestinal disease; history of major bleeding
Interventions
N=79 high-dose aspirin (at a dose of 100 mg BID)
N=86 low-dose aspirin (at a dose of 100 mg once daily)
Primary outcome
Serum thromboxane B2 after 2 weeks
4
19.3
19.3 ng/mL
14.5 ng/mL
9.7 ng/mL
4.8 ng/mL
0.0 ng/mL
High-dose aspirin
Low-dose aspirin
Significant decrease ▼
Significant decrease in serum thromboxane B2 after 2 weeks (4 ng/mL vs. 19.3 ng/mL; AD -15.3 ng/mL, 95% CI -24.38 to -6.22)
Secondary outcomes
No significant difference in urinary prostacyclin metabolite excretion after 2 weeks (87 pg/mg creatinine vs. 89 pg/mg creatinine; AD -2 pg/mg creatinine, 95% CI -11.72 to 7.72)
Significant decrease in urinary thromboxane metabolite after 2 weeks (367 pg/mg creatinine vs. 457 pg/mg creatinine; AD -90 pg/mg creatinine, 95% CI -143.4 to -36.6)
Conclusion
In patients with essential thrombocythemia who are chronically on once-daily low-dose aspirin, high-dose aspirin was superior to low-dose aspirin with respect to serum thromboxane B2 after 2 weeks.
Reference
Bianca Rocca, Alberto Tosetto, Silvia Betti et al. A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia. Blood. 2020 Jul 9;136(2):171-182.
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