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Oral Concurrent Session 4 - Hypertension

Oral Concurrent Sessions

(41) ASpirin in Placental and maternal Endothelial cell Regulation IN pre-eclampsia (ASPERIN Trial): Primary Outcome

Wednesday, February 14, 2024
10:00 AM - 10:15 AM  
Location: Potomac Ballroom AB, Ballroom Level
Objective:

Recent findings suggest biophysical differences in uterine artery Doppler profile can be identified with exposure to low dose aspirin. Dose effects however have not been adequately investigated. We hypothesized variations in uterine artery pulsatility index (UtA PI) may be identified based on dose.

Study Design:

Between April 2019 and July 2022, a phase II open-label, randomized trial was performed to compare UtA PI in three subpopulations: high-risk randomly assigned to 81 mg aspirin daily, high-risk randomly assigned 162 mg of aspirin daily, and a convenience control group (no risk factor) (NCT03893630). Singletons with or without a major criterion risk factor defined by the USPSTF were enrolled and randomized by a scheme stratified by BMI. Patients initiated treatment after first trimester measurement of UtA PI. Serial UtA PI assessments were performed at 18-22 weeks and 28-32 weeks.  Repeated measures using a mixed model analysis was performed to assess the effect of dose over time.  

Results:

The ASPERIN trial enrolled 209 subjects (69 treated with 81 mg, 75 to 162 mg, and 65 controls). Demographics differed between groups (Table). Analysis of change in UtA PI over time which incorporated aspirin exposure, BMI, and trimester revealed a significant interaction between exposure in the three groups, P=.02. However, excluding controls, a significant difference was not observed in UtA PI based on dose, P=0.416. In a post hoc analysis limited to the obese subpopulation, BMI ≥30, the UtA PI did not identify differences between the high-risk subgroups at 28-32 weeks, 1.0 ± 0.09 SE vs 1.14 ± .08 SE, P=.24; and at 18-22 weeks 1.16 ± .097 SE vs 1.13 ± 0.085, P=0.78. The aspirin-exposed high-risk groups had a cumulative non-significant increase in perinatal mortality, p=0.327, but a dose effect on mortality was not present. 

Conclusion:

A change in UtA PI over time was observed as expected; however, in a trial population enrolled by risk factors, dose of aspirin did not demonstrate a significant treatment effect on UtA PI in a phase II study.