TY - JOUR
T1 - Outcomes among patients with peripheral artery disease in the Aspirin Dosing
T2 - A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study
AU - Weissler, E. Hope
AU - Stebbins, Amanda
AU - Wruck, Lisa
AU - Muñoz, Daniel
AU - Gupta, Kamal
AU - Girotra, Saket
AU - Whittle, Jeff
AU - Benziger, Catherine P.
AU - Polonsky, Tamar S.
AU - Bradley, Steven M.
AU - Hammill, Bradley G.
AU - Merritt, James G.
AU - Zemon, Doris N.
AU - Hernandez, Adrian F.
AU - Jones, W. Schuyler
N1 - Publisher Copyright:
© The Author(s) 2023.
PY - 2023/4
Y1 - 2023/4
N2 - 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
AB - 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
KW - antiplatelet therapy
KW - clinical trial methodology
KW - evidence-based medicine
KW - peripheral artery disease (PAD)
KW - pragmatic trials
UR - http://www.scopus.com/inward/record.url?scp=85151814793&partnerID=8YFLogxK
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U2 - 10.1177/1358863X231154951
DO - 10.1177/1358863X231154951
M3 - Article
C2 - 37025023
AN - SCOPUS:85151814793
SN - 1358-863X
VL - 28
SP - 122
EP - 130
JO - Vascular Medicine (United Kingdom)
JF - Vascular Medicine (United Kingdom)
IS - 2
ER -