Key result
High-dose aspirin fails to reduce major cardiovascular events versus 81 mg in PAD.
Why the study?
The effects of aspirin dose on clinical outcomes in patients with PAD and their participation patterns in a pragmatic randomized controlled trial were not well understood.
Does aspirin 325 mg reduce cardiovascular events compared to aspirin 81 mg in patients with peripheral artery disease?
RCT (n=14,662)
Open-label
Randomized
Yes
Does aspirin 325 mg reduce cardiovascular events compared to aspirin 81 mg in patients with peripheral artery disease?
Hazard Ratio: 1.05 (95% CI 0.88–1.25)
Absolute Event Rate: 13.84% vs 13.68%
In patients with peripheral artery disease, aspirin 325 mg did not reduce cardiovascular events compared to aspirin 81 mg, reinforcing the lack of benefit for higher-dose aspirin in this population.
No benefit from 325 mg over 81 mg aspirin in PAD; confirms ADAPTABLE results and supports low-dose preference.
Background: We aimed to understand the effects of aspirin dose on outcomes in patients with peripheral artery disease (PAD) as well as their participation in a pragmatic randomized controlled trial. Methods: In a subanalysis of the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study, we compared aspirin doses (81 vs 325 mg) among participants with PAD and study participation metrics in patients with and without PAD. The primary outcome composite was all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. Results: Among 14,662 participants enrolled in ADAPTABLE with PAD status available, 3493 (23.8%) had PAD. Participants with PAD were more likely to experience the primary composite (13.76% vs 5.31%, p < 0.001), all-cause mortality (7.55% vs 3.01%, p < 0.001), myocardial infarction (5.71% vs 2.09%, p < 0.001), stroke (2.45% vs 0.86%, p < 0.001), and major bleeding (1.19% vs 0.44%, p < 0.001). A higher aspirin dose did not reduce the primary outcome in patients with PAD (13.68% vs 13.84% in 81 mg and 325 mg groups; OR 1.05, 95% CI 0.88–1.25). Participants with PAD were less likely to enroll via email (33.0% vs 41.9%, p < 0.0001), less likely to choose internet follow-up (79.2% vs 89.5%, p < 0.0001), and were more likely to change their aspirin doses (39.7% vs 30.7%, p < 0.0001). Conclusions: ADAPTABLE participants with PAD did not benefit from a higher dose of aspirin and participated in the study differently from those without PAD. These results reinforce the need for additional PAD-specific research and suggest that different trial strategies may be needed for optimal engagement of patients with PAD. (ClinicalTrials.gov Identifier: NCT02697916)
No takes yet. Share an insight, caveat, or question.
Weissler et al. (2023) conducted an RCT in Peripheral artery disease and established atherosclerotic cardiovascular disease (n=14,662). Aspirin vs. 81 mg was evaluated on Composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke (HR 1.05, 95% CI 0.88-1.25). A higher dose of aspirin (325 mg) did not reduce the primary composite outcome of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke compared to 81 mg in patients with peripheral artery disease (HR 1.05).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: