Impact of aspirin dose according to race in secondary prevention of atherosclerotic cardiovascular disease: a secondary analysis of the ADAPTABLE randomised controlled trial. BMJ Open 2024 Aug 07;14(8):e078197
Date
08/09/2024Pubmed ID
39117415Pubmed Central ID
PMC11407226DOI
10.1136/bmjopen-2023-078197Scopus ID
2-s2.0-85201041104 (requires institutional sign-in at Scopus site)Abstract
OBJECTIVES: To evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD).
DESIGN: A secondary analysis of the randomised controlled trial ADAPTABLE was performed.
SETTING: The study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA.
PARTICIPANTS: Among 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%).
INTERVENTIONS: Participants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months.
PRIMARY AND SECONDARY OUTCOMES MEASURES: The primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion.
RESULTS: Estimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints.
CONCLUSION: Race is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race.
TRIAL REGISTRATION NUMBER: NCT02697916.
Author List
Marquis-Gravel G, Mulder H, Wruck LM, Benziger CP, Effron MB, Farrehi PM, Girotra S, Gupta K, Kripalani S, Muñoz D, Polonsky TS, Whittle J, Harrington R, Rothman R, Hernandez AF, Jones WSAuthor
Jeffrey Whittle MD Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedAspirin
Atherosclerosis
Cardiovascular Diseases
Dose-Response Relationship, Drug
Female
Hemorrhage
Hospitalization
Humans
Male
Middle Aged
Myocardial Infarction
Platelet Aggregation Inhibitors
Secondary Prevention
Stroke
Treatment Outcome
United States