TY - JOUR
T1 - Comparative effectiveness of aspirin dosing in cardiovascular disease
AU - Jones, W. Schuyler
AU - Mulder, Hillary
AU - Wruck, Lisa M.
AU - Pencina, Michael J.
AU - Kripalani, Sunil
AU - Muñoz, Daniel
AU - Crenshaw, David L.
AU - Effron, Mark B.
AU - Re, Richard N.
AU - Gupta, Kamal
AU - David Anderson, R.
AU - Pepine, Carl J.
AU - Handberg, Eileen M.
AU - Manning, Brittney R.
AU - Jain, Sandeep K.
AU - Girotra, Saket
AU - Riley, Danielle
AU - DeWalt, Darren A.
AU - Whittle, Jeff
AU - Goldberg, Ythan H.
AU - Roger, Veronique L.
AU - Hess, Rachel
AU - Benziger, Catherine P.
AU - Farrehi, Peter
AU - Zhou, Li
AU - Ford, Daniel E.
AU - Haynes, Kevin
AU - VanWormer, Jeffrey J.
AU - Knowlton, Kirk U.
AU - Kraschnewski, Jennifer L.
AU - Polonsky, Tamar S.
AU - Fintel, Dan J.
AU - Ahmad, Faraz S.
AU - McClay, James C.
AU - Campbell, James R.
AU - Bell, Douglas S.
AU - Fonarow, Gregg C.
AU - Bradley, Steven M.
AU - Paranjape, Anuradha
AU - Roe, Matthew T.
AU - Robertson, Holly R.
AU - Curtis, Lesley H.
AU - Sharlow, Amber G.
AU - Berdan, Lisa G.
AU - Hammill, Bradley G.
AU - Harris, Debra F.
AU - Qualls, Laura G.
AU - Marquis-Gravel, Guillaume
AU - Modrow, Madelaine F.
AU - Marcus, Gregory M.
AU - Carton, Thomas W.
AU - Nauman, Elizabeth
AU - Waitman, Lemuel R.
AU - Kho, Abel N.
AU - Shenkman, Elizabeth A.
AU - McTigue, Kathleen M.
AU - Kaushal, Rainu
AU - Masoudi, Frederick A.
AU - Antman, Elliott M.
AU - Davidson, Desiree R.
AU - Edgley, Kevin
AU - Merritt, James G.
AU - Brown, Linda S.
AU - Zemon, Doris N.
AU - McCormick, Thomas E.
AU - Alikhaani, Jacqueline D.
AU - Gregoire, Kenneth C.
AU - Rothman, Russell L.
AU - Harrington, Robert A.
AU - Hernandez, Adrian F.
AU - Sandu, Oana A.
N1 - Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/5/27
Y1 - 2021/5/27
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJMoa2102137
DO - 10.1056/NEJMoa2102137
M3 - Article
C2 - 33999548
AN - SCOPUS:85106488259
SN - 0028-4793
VL - 384
SP - 1981
EP - 1990
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 21
ER -