Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease
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Published on: February 28, 2012
Guillaume Marquis-Gravel1,2, Amanda Stebbins1, Lisa M Wruck1
1Duke Clinical Research Institute Durham NC.
Insights
Aspirin dosage (81 mg vs. 325 mg daily) did not significantly alter clinical outcomes in atherosclerotic cardiovascular disease patients. Age did not modify the effectiveness or safety of aspirin dosing in secondary prevention.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Increasing age is linked to higher risks of ischemic and bleeding events in atherosclerotic cardiovascular disease (ASCVD).
- Optimal aspirin dosage for secondary prevention in ASCVD patients, considering age, remains an area of investigation.
Purpose of the Study:
- To determine the impact of different daily aspirin doses (81 mg vs. 325 mg) on clinical outcomes in patients with atherosclerotic cardiovascular disease.
- To assess whether age modifies the effect of aspirin dose on effectiveness and safety endpoints.
Main Methods:
- The ADAPTABLE trial randomized 15,076 ASCVD patients to daily aspirin doses of 81 mg or 325 mg.
- Primary effectiveness endpoint: all-cause death, myocardial infarction, or stroke hospitalization.
- Primary safety endpoint: bleeding requiring transfusion hospitalization.
Main Results:
- In patients <65 years, the primary endpoint occurred in 7.54% (81 mg) vs. 6.80% (325 mg).
- In patients ≥65 years, the primary endpoint occurred in 7.12% (81 mg) vs. 7.96% (325 mg).
- No significant interaction was found between age and aspirin dose for effectiveness or safety endpoints.
Conclusions:
- Aspirin dosage (81 mg or 325 mg daily) does not significantly alter clinical outcomes in the secondary prevention of atherosclerotic cardiovascular disease.
- Age does not modify the impact of aspirin dosing on clinical endpoints in this patient population.
Background:
In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease.
Methods And Results:
In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant (P=0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points (P>0.05 for all).
Conclusions:
Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.
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