Comparative effectiveness of aspirin dosing in cardiovascular disease

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.

From New England Journal of Medicine, , Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease, 384, 1981-1990. Copyright © 2021 Massachusetts Medical Society. Reprinted with permission.


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Work Title Comparative effectiveness of aspirin dosing in cardiovascular disease
Open Access
  1. W. Schuyler Jones
  2. Hillary Mulder
  3. Lisa M. Wruck
  4. Michael J. Pencina
  5. Sunil Kripalani
  6. Daniel Muñoz
  7. David L. Crenshaw
  8. Mark B. Effron
  9. Richard N. Re
  10. Kamal Gupta
  11. R. David Anderson
  12. Carl J. Pepine
  13. Eileen M. Handberg
  14. Brittney R. Manning
  15. Sandeep K. Jain
  16. Saket Girotra
  17. Danielle Riley
  18. Darren A. DeWalt
  19. Jeff Whittle
  20. Ythan H. Goldberg
  21. Veronique L. Roger
  22. Rachel Hess
  23. Catherine P. Benziger
  24. Peter Farrehi
  25. Li Zhou
  26. Daniel E. Ford
  27. Kevin Haynes
  28. Jeffrey J. VanWormer
  29. Kirk U. Knowlton
  30. Jennifer L. Kraschnewski
  31. Tamar S. Polonsky
  32. Dan J. Fintel
  33. Faraz S. Ahmad
  34. James C. McClay
  35. James R. Campbell
  36. Douglas S. Bell
  37. Gregg C. Fonarow
  38. Steven M. Bradley
  39. Anuradha Paranjape
  40. Matthew T. Roe
  41. Holly R. Robertson
  42. Lesley H. Curtis
  43. Amber G. Sharlow
  44. Lisa G. Berdan
  45. Bradley G. Hammill
  46. Debra F. Harris
  47. Laura G. Qualls
  48. Guillaume Marquis-Gravel
  49. Madelaine F. Modrow
  50. Gregory M. Marcus
  51. Thomas W. Carton
  52. Elizabeth Nauman
  53. Lemuel R. Waitman
  54. Abel N. Kho
  55. Elizabeth A. Shenkman
  56. Kathleen M. McTigue
  57. Rainu Kaushal
  58. Frederick A. Masoudi
  59. Elliott M. Antman
  60. Desiree R. Davidson
  61. Kevin Edgley
  62. James G. Merritt
  63. Linda S. Brown
  64. Doris N. Zemon
  65. Thomas E. McCormick
  66. Jacqueline D. Alikhaani
  67. Kenneth C. Gregoire
  68. Russell L. Rothman
  69. Robert A. Harrington
  70. Adrian F. Hernandez
  71. Oana A. Sandu
License In Copyright (Rights Reserved)
Work Type Article
  1. New England Journal of Medicine
Publication Date May 27, 2021
Publisher Identifier (DOI)
Deposited February 17, 2023




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Work History

Version 1

  • Created
  • Added nejmoa2102137.pdf
  • Added Creator W. Schuyler Jones
  • Added Creator Hillary Mulder
  • Added Creator Lisa M. Wruck
  • Added Creator Michael J. Pencina
  • Added Creator Sunil Kripalani
  • Added Creator Daniel Muñoz
  • Added Creator David L. Crenshaw
  • Added Creator Mark B. Effron
  • Added Creator Richard N. Re
  • Added Creator Kamal Gupta
  • Added Creator R. David Anderson
  • Added Creator Carl J. Pepine
  • Added Creator Eileen M. Handberg
  • Added Creator Brittney R. Manning
  • Added Creator Sandeep K. Jain
  • Added Creator Saket Girotra
  • Added Creator Danielle Riley
  • Added Creator Darren A. DeWalt
  • Added Creator Jeff Whittle
  • Added Creator Ythan H. Goldberg
  • Added Creator Veronique L. Roger
  • Added Creator Rachel Hess
  • Added Creator Catherine P. Benziger
  • Added Creator Peter Farrehi
  • Added Creator Li Zhou
  • Added Creator Daniel E. Ford
  • Added Creator Kevin Haynes
  • Added Creator Jeffrey J. VanWormer
  • Added Creator Kirk U. Knowlton
  • Added Creator Jennifer L. Kraschnewski
  • Added Creator Tamar S. Polonsky
  • Added Creator Dan J. Fintel
  • Added Creator Faraz S. Ahmad
  • Added Creator James C. McClay
  • Added Creator James R. Campbell
  • Added Creator Douglas S. Bell
  • Added Creator Gregg C. Fonarow
  • Added Creator Steven M. Bradley
  • Added Creator Anuradha Paranjape
  • Added Creator Matthew T. Roe
  • Added Creator Holly R. Robertson
  • Added Creator Lesley H. Curtis
  • Added Creator Amber G. Sharlow
  • Added Creator Lisa G. Berdan
  • Added Creator Bradley G. Hammill
  • Added Creator Debra F. Harris
  • Added Creator Laura G. Qualls
  • Added Creator Guillaume Marquis-Gravel
  • Added Creator Madelaine F. Modrow
  • Added Creator Gregory M. Marcus
  • Added Creator Thomas W. Carton
  • Added Creator Elizabeth Nauman
  • Added Creator Lemuel R. Waitman
  • Added Creator Abel N. Kho
  • Added Creator Elizabeth A. Shenkman
  • Added Creator Kathleen M. McTigue
  • Added Creator Rainu Kaushal
  • Added Creator Frederick A. Masoudi
  • Added Creator Elliott M. Antman
  • Added Creator Desiree R. Davidson
  • Added Creator Kevin Edgley
  • Added Creator James G. Merritt
  • Added Creator Linda S. Brown
  • Added Creator Doris N. Zemon
  • Added Creator Thomas E. McCormick
  • Added Creator Jacqueline D. Alikhaani
  • Added Creator Kenneth C. Gregoire
  • Added Creator Russell L. Rothman
  • Added Creator Robert A. Harrington
  • Added Creator Adrian F. Hernandez
  • Added Creator Oana A. Sandu
  • Published