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.).
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.).
Authors: Scott E Wenderfer; Joyce C Chang; Amy Goodwin Davies; Ingrid Y Luna; Rebecca Scobell; Cora Sears; Bliss Magella; Mark Mitsnefes; Brian R Stotter; Vikas R Dharnidharka; Katherine D Nowicki; Bradley P Dixon; Megan Kelton; Joseph T Flynn; Caroline Gluck; Mahmoud Kallash; William E Smoyer; Andrea Knight; Sangeeta Sule; Hanieh Razzaghi; L Charles Bailey; Susan L Furth; Christopher B Forrest; Michelle R Denburg; Meredith A Atkinson Journal: Clin J Am Soc Nephrol Date: 2021-11-03 Impact factor: 8.237
Authors: Muhammad Shariq Usman; Harriette G C Van Spall; Stephen J Greene; Ambarish Pandey; Darren K McGuire; Ziad A Ali; Robert J Mentz; Gregg C Fonarow; John A Spertus; Stefan D Anker; Javed Butler; Stefan K James; Muhammad Shahzeb Khan Journal: Nat Rev Cardiol Date: 2022-05-17 Impact factor: 49.421
Authors: Mikhail N Kosiborod; James L Januzzi; John A Spertus; Mary C Birmingham; Michael Nassif; C V Damaraju; Antonio Abbate; Javed Butler; David E Lanfear; Ildiko Lingvay Journal: Nat Med Date: 2022-02-28 Impact factor: 87.241
Authors: Charlie Harper; Marion Mafham; William Herrington; Natalie Staplin; William Stevens; Karl Wallendszus; Richard Haynes; Martin J Landray; Sarah Parish; Louise Bowman; Jane Armitage Journal: JAMA Netw Open Date: 2021-12-01
Authors: Kyungmann Kim; Charles H Hennekens; Lisa Martinez; J Michael Gaziano; Marc A Pfeffer; Bianca Biglione; Alexander Gitin; Jeanne Bell McCabe; Thomas D Cook; David L DeMets; Sarah K Wood Journal: Fam Med Community Health Date: 2021-12