Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease
| Autor: | Russell L. Rothman, Douglas S. Bell, Sunil Kripalani, Sandeep Jain, Kenneth C. Gregoire, Madelaine Faulkner Modrow, W. Schuyler Jones, Matthew T. Roe, James G. Merritt, Richard N. Re, Thomas E. McCormick, Rachel Hess, Eileen M. Handberg, Ythan H. Goldberg, Daniel Muñoz, Abel N. Kho, Michael J. Pencina, Anuradha Paranjape, Gregory M. Marcus, Daniel E. Ford, David L. Crenshaw, Desiree R. Davidson, Li Zhou, Guillaume Marquis-Gravel, Lisa M. Wruck, Faraz S. Ahmad, James C. McClay, Catherine P. Benziger, Jeffrey J. VanWormer, Rainu Kaushal, Elizabeth Shenkman, Jeff Whittle, Lesley H. Curtis, Oana A. Sandu, Laura G. Qualls, Lemuel R. Waitman, Thomas W Carton, Tamar S. Polonsky, Kirk U. Knowlton, Darren A. DeWalt, Elliott M. Antman, James R. Campbell, Linda S. Brown, Véronique L. Roger, Jennifer L. Kraschnewski, R. David Anderson, Doris N. Zemon, Debra F. Harris, Holly Robertson, Kevin Haynes, Elizabeth Nauman, Kevin Edgley, Adrian F. Hernandez, Gregg C. Fonarow, Saket Girotra, Carl J. Pepine, Frederick A. Masoudi, Robert A. Harrington, Steven M. Bradley, Brittney R. Manning, Dan J. Fintel, Kamal Gupta, Jacqueline D. Alikhaani, Amber G. Sharlow, Kathleen M. McTigue, Lisa G. Berdan, Peter Farrehi, Danielle Riley, Mark B. Effron, Bradley G. Hammill, Hillary Mulder |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Comparative Effectiveness Research Myocardial Infarction Disease 030204 cardiovascular system & hematology Cardiovascular Medical and Health Sciences law.invention Coronary artery disease 0302 clinical medicine Cardiologists Randomized controlled trial law Secondary Prevention 030212 general & internal medicine Myocardial infarction Stroke Aspirin General Medicine Middle Aged Hospitalization Heart Disease Cardiovascular Diseases 6.1 Pharmaceuticals Cardiology Female Patient Safety medicine.drug medicine.medical_specialty ADAPTABLE Team Clinical Trials and Supportive Activities Hemorrhage Article Medication Adherence 03 medical and health sciences Geriatric cardiology Clinical Research Internal medicine General & Internal Medicine medicine Humans cardiovascular diseases Dosing Heart Disease - Coronary Heart Disease Aged business.industry Evaluation of treatments and therapeutic interventions medicine.disease Atherosclerosis Good Health and Well Being business Platelet Aggregation Inhibitors |
| Zdroj: | N Engl J Med The New England journal of medicine, vol 384, iss 21 |
| ISSN: | 1533-4406 |
| Popis: | 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.). |
| Databáze: | OpenAIRE |
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