Key result
Enteric-coated aspirin shows no benefit over plain aspirin for reducing non-responsiveness in ischemic stroke.
Why the study?
Uncertainty remains regarding the impact of enteric-coated aspirin compared to plain aspirin on secondary prevention of ischemic stroke.
Does enteric-coated aspirin improve aspirin responsiveness compared to plain aspirin in patients with suspected or newly diagnosed ischemic stroke?
Cohort (n=42)
Does enteric-coated aspirin improve aspirin responsiveness compared to plain aspirin in patients with suspected or newly diagnosed ischemic stroke?
Effect estimate: OR 0.78 (95% CI 0.20-3.11)
Absolute Event Rate: 23.8% vs 28.6%
p-value: p=0.726
In patients with suspected or newly diagnosed ischemic stroke, enteric-coated aspirin did not significantly alter the rate of aspirin non-responsiveness compared to plain aspirin, though diabetic patients with HbA1c > 6.5% had a significantly higher risk of non-response.
Enteric-coated aspirin should not supplant plain aspirin for responsiveness in acute ischemic stroke; this Level 3 cohort finding leaves open the need for randomized trials.
BACKGROUND AND PURPOSE: Uncertainty remains regarding the impact of enteric-coated aspirin (EC-ASA) on secondary prevention of ischemic stroke compared to plain aspirin (P-ASA). Hence, this study was designed to investigate the effect of EC formulation on ASA response via evaluating thromboxane B2 (TXB2) levels in patients with suspected or newly diagnosed stroke. METHODS: A prospective cohort study on suspected or newly diagnosed ischemic stroke patients who are aspirin-naive was conducted. Patients were received either EC aspirin or plain aspirin for at least 3 days. The primary outcome was the proportion of aspirin non-responsiveness between two groups (level of residual serum TXB2 associated with elevated thrombotic risk (< 99.0% inhibition or TXB2 > 3.1 ng/ml) within 72 h after three daily aspirin doses, while secondary outcomes were the incidence of early gastrointestinal tract (GIT) bleeding with the various aspirin preparations. (Trial registration: Clinicaltrials.gov NCT04330872 registered on 02 April 2020). RESULTS: Of 42 patients, ischemic strokes were confirmed in both P-ASA (81%) and EC-ASA (67%) arms. ASA non-responsiveness showed no significant difference between the two formulations (P-ASA vs. EC-ASA; 28.6% vs 23.8%; P = 0.726). Univariate and multivariate logistic regression analysis showed that patients treated with EC-ASA were more likely to have a lower rate of non-responders compared to P-ASA (unadjusted OR 0.78; 95% CI 0.20, 3.11); with the risk highest in type 2 diabetic patients with HBA1c > 6.5% (adjusted OR 6; 95% CI 1.02, 35.27; P = 0.047). No incidence of GIT bleeding observed throughout the study. CONCLUSION: A significant proportion of ASA non-responsiveness was recorded regardless of ASA formulation administered. The increased risk of ASA non-responsiveness in diabetic patients needs further exploration by larger prospective studies.
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Elshafei et al. (2022) conducted a cohort in Suspected or newly diagnosed ischemic stroke (n=42). Enteric-coated aspirin (EC-ASA) vs. Plain aspirin (P-ASA) was evaluated on Proportion of aspirin non-responsiveness (residual serum TXB2 < 99.0% inhibition or TXB2 > 3.1 ng/ml) (OR 0.78, 95% CI 0.20-3.11, p=0.726). Enteric-coated aspirin did not significantly differ from plain aspirin in the rate of aspirin non-responsiveness among patients with suspected or newly diagnosed ischemic stroke (23.8% vs 28.6%; P=0.726).
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