Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease
- PMID: 33999548
- PMCID: PMC9908069
- DOI: 10.1056/NEJMoa2102137
Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease
Abstract
Background: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.
Methods: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.
Results: A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).
Conclusions: In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).
Copyright © 2021 Massachusetts Medical Society.
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Comment in
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Pragmatic Trials - Need for ADAPTABLE Design.N Engl J Med. 2021 May 27;384(21):2065-2066. doi: 10.1056/NEJMe2106430. Epub 2021 May 15. N Engl J Med. 2021. PMID: 33999542 No abstract available.
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Aspirin dosing for secondary prevention in ASCVD.Nat Rev Cardiol. 2021 Aug;18(8):544. doi: 10.1038/s41569-021-00576-7. Nat Rev Cardiol. 2021. PMID: 34040183 No abstract available.
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Are US cardiologists ADAPTABLE to considering low-dose aspirin for secondary prevention?Eur Heart J. 2021 Jul 8;42(26):2525-2526. doi: 10.1093/eurheartj/ehab357. Eur Heart J. 2021. PMID: 34172997 No abstract available.
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Aspirin Dosing in Cardiovascular Disease.N Engl J Med. 2021 Aug 19;385(8):764. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407351 No abstract available.
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Aspirin Dosing in Cardiovascular Disease.N Engl J Med. 2021 Aug 19;385(8):764. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407352 No abstract available.
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Aspirin Dosing in Cardiovascular Disease.N Engl J Med. 2021 Aug 19;385(8):764-765. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407353 No abstract available.
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In ASCVD, 81 mg and 325 mg of aspirin did not differ for CV or bleeding events.Ann Intern Med. 2021 Oct;174(10):JC118. doi: 10.7326/ACPJ202110190-118. Epub 2021 Oct 5. Ann Intern Med. 2021. PMID: 34606309
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