Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

doi:10.1056/NEJMoa2102137

Randomized Controlled Trial

. 2021 May 27;384(21):1981-1990.

doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

W Schuyler Jones¹, Hillary Mulder¹, Lisa M Wruck¹, Michael J Pencina¹, Sunil Kripalani¹, Daniel Muñoz¹, David L Crenshaw¹, Mark B Effron¹, Richard N Re¹, Kamal Gupta¹, R David Anderson¹, Carl J Pepine¹, Eileen M Handberg¹, Brittney R Manning¹, Sandeep K Jain¹, Saket Girotra¹, Danielle Riley¹, Darren A DeWalt¹, Jeff Whittle¹, Ythan H Goldberg¹, Veronique L Roger¹, Rachel Hess¹, Catherine P Benziger¹, Peter Farrehi¹, Li Zhou¹, Daniel E Ford¹, Kevin Haynes¹, Jeffrey J VanWormer¹, Kirk U Knowlton¹, Jennifer L Kraschnewski¹, Tamar S Polonsky¹, Dan J Fintel¹, Faraz S Ahmad¹, James C McClay¹, James R Campbell¹, Douglas S Bell¹, Gregg C Fonarow¹, Steven M Bradley¹, Anuradha Paranjape¹, Matthew T Roe¹, Holly R Robertson¹, Lesley H Curtis¹, Amber G Sharlow¹, Lisa G Berdan¹, Bradley G Hammill¹, Debra F Harris¹, Laura G Qualls¹, Guillaume Marquis-Gravel¹, Madelaine F Modrow¹, Gregory M Marcus¹, Thomas W Carton¹, Elizabeth Nauman¹, Lemuel R Waitman¹, Abel N Kho¹, Elizabeth A Shenkman¹, Kathleen M McTigue¹, Rainu Kaushal¹, Frederick A Masoudi¹, Elliott M Antman¹, Desiree R Davidson¹, Kevin Edgley¹, James G Merritt¹, Linda S Brown¹, Doris N Zemon¹, Thomas E McCormick 3rd¹, Jacqueline D Alikhaani¹, Kenneth C Gregoire¹, Russell L Rothman¹, Robert A Harrington¹, Adrian F Hernandez¹; ADAPTABLE Team

Collaborators, Affiliations

Collaborators

ADAPTABLE Team:
Robert A Harrington, Russell Rothman, Adrian F Hernandez, W Schuyler Jones, Lesley H Curtis, Greg Marcus, Henry Cruz, Patient Partner, Jacqueline Alikhaani, Matthew Roe, Lisa Berdan, Holly Robertson, Amber Sharlow, Brad Hammill, Debra Harris, Laura Qualls, Hillary Mulder, Lisa Wruck, Michael Pencina, Guillaume Marquis-Gravel, Clyde Yancy, Dave Demets, Judith Hochman, Bernard Gersh, Alice Jacobs, Debbe McCall, Hugo Campos, Desiree Davidson, Kevin Edgley, Greg Merritt, Linda Brown, Henry Cruz, Nadine Zemon, Tom McCormick, Ken Gregoire, Abel Kho, Russ Waitman, Veronique Roger, Rainu Kaushal, Elizabeth Shenkman, Kathleen McTigue, Douglas Bell, Thomas Carton, A Kho, M Nodal, D Fintel, F Ahmad, A Williams, R C Shah, A Flores, M Jansen, T Polonsky, D Hood, J French, P Dexter, D Riley, N Smith, S Girotra, R Waitman, S Chandaka, T McMahon, K Greening, Y Murr, K Munshi, H Sandoval, K Gupta, L Verhagen, T Foss, J VanWormer, K Osinski, A Schwarz, S Cornell, M Berendt, J Whittle, A Mosa, V Mandhadi, L Lawrence, A Kumar, D Mehr, J McClay, P Guda, A Wolfe, C Geary, K Ostlund, L Larson, R Harper, J Campbell, L Manuel, O Suarez, J Polanco, A Tirado-Ramos, S Tsai, J Cai, M Bell, P Reeder, T Bosler, K Wilkinson, S Antony, S Das, K Hanson, C Rodgers, E Ebere, S Bradley, M Miedema, R Thiel, B Lemke, I Haller, C Benziger, S Rea, D Ward, H Maestas, N Garbe, L Evans, P Haug, K Knowlton, V Roger, E Koepsell, S Brue, J Bauman, B Bucknell, H Jouni, M Jindra, J Harper, M Bright, B Lampert, S Fernandez, J Ryan, S Brougher, M Harris, A Fishstom, L Ferguson, D Braswell, K Shah, B Nallamothu, C Friedman, D Williams, P Farrehi, W S Jones, J Curtis, J Hamill, B O'Brien, M B Summers, X Idriss, W Pohlman, K Thompson, D Dewalt, R Bradford, T Barber, D Crenshaw, K Goggins, W Hucke, S Kripalani, S McCrate, J Moore, D Muñoz, C O'Donnell, C Pritchett, C Roumie, R Servis, K Worley, J Borgman, L Doomy, K Blinson, G Rosenthal, L Zhou, O A Sandu, Y Goldberg, E Fass, D McKee, J Lin, C Pulgarin, S Blecker, R Kaushal, A Cohen, N Goldberg, S Chaudhary, A LaMar, T Haque, K LaScalea, R Kim, T Campion, B Shenkman, B Roth, D Bright, J Hensley, T Chou, J-A Norton, C Garrett, C Pepine, D Anderson, E Handberg, B Johnson, T Robinson, D Allen, M Warrington, H Seifein, H Noel, V K Kasi, D Gumas, H Lehmann, M Gauvey-Kern, D Ford, T Metkus, J McCullough, K Confer, C Chuang, J Kraschnewski, M Weiner, J Turella, A Paranjape, K McTigue, N Cappella, P Kant, A Arita, E Klawson, S Jain, A Huffman, C Moynier, T Greimes, B Steinberg, R Hess, M Zachariah, D Bell, G Fonarow, T Carton, B Nauman, L Rudov, L Hall, L Clariday, R Baker, P McCullough, C Parke, D Rachal, R Jenkins, S Cohen, G Liu, M Effron, R Re, A Irimpen, M Pletcher, M Faulkner, M Cziraky, Q Shi, A Marshall, E R Kennedy, K Haynes, V Nair

Affiliation

¹ From Duke Clinical Research Institute, Duke University, Durham (W.S.J., H.M., L.M.W., M.J.P., M.T.R., H.R.R., L.H.C., A.G.S., L.G.B., B.G.H., D.F.H., L.G.Q., G.M.-G., A.F.H.), University of North Carolina at Chapel Hill, Chapel Hill (D.A.D.), and Wake Forest University School of Medicine, Winston-Salem (L.Z.) - all in North Carolina; Vanderbilt University Medical Center, Nashville (S.K., D.M., D.L.C., R.L.R.); Ochsner Health (M.B.E., R.N.R.) and Louisiana Public Health Institute (T.W.C., E.N.) - both in New Orleans; University of Kansas Medical Center, Kansas City (K.G.); University of Florida, Gainesville (R.D.A., C.J.P., E.M.H., B.R.M., E.A.S.); University of Pittsburgh Medical Center, Pittsburgh (S.K.J., K.M.M.), Penn State College of Medicine, Hershey (J.L.K.), and Temple University, Philadelphia (A.P.) - all in Pennsylvania; University of Iowa, Iowa City (S.G., D.R.); Medical College of Wisconsin, Milwaukee (J.W.), and Marshfield Clinic Research Institute, Marshfield (J.J.V.) - both in Wisconsin; Albert Einstein College of Medicine, Bronx (Y.H.G.), and Weill Cornell Medicine and New York-Presbyterian Hospital, New York (R.K.) - both in New York; Mayo Clinic, Rochester (V.L.R.), Essentia Health Heart and Vascular Center, Duluth (C.P.B.), and Allina Health and Minneapolis Heart Institute, Minneapolis (S.M.B.) - all in Minnesota; University of Utah School of Medicine (R.H.) and Intermountain Medical Center Heart Institute (K.U.K.) - both in Salt Lake City; University of Michigan, Ann Arbor (P.F.); Johns Hopkins University School of Medicine, Baltimore (D.E.F.); HealthCore, Wilmington, DE (K.H.); University of Chicago Medicine (T.S.P.) and Northwestern University Feinberg School of Medicine (D.J.F., F.S.A., A.M.K.) - both in Chicago; University of Nebraska Medical Center, Omaha (J.C.M., J.R.C.); University of California, Los Angeles, Los Angeles (D.S.B., G.C.F.), University of California, San Francisco, San Francisco (M.F.M., G.M.M.), and Stanford University School of Medicine, Stanford (R.A.H.) - all in California; University of Missouri School of Medicine, Columbia (L.R.W.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (F.A.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.M.A.); Chicago (D.R.D.); St. Joseph, MO (K.E.); Brighton, MI (J.G.M.); Columbia, TN (L.S.B.); Alachua, FL (D.N.Z.); Columbia, MD (T.E.M.); North Hills, CA (J.D.A.); and Metairie, LA (K.C.G.).

PMID: 33999548
PMCID: PMC9908069
DOI: 10.1056/NEJMoa2102137

Randomized Controlled Trial

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

W Schuyler Jones et al. N Engl J Med. 2021.

. 2021 May 27;384(21):1981-1990.

doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.

Authors

Collaborators

ADAPTABLE Team:
Robert A Harrington, Russell Rothman, Adrian F Hernandez, W Schuyler Jones, Lesley H Curtis, Greg Marcus, Henry Cruz, Patient Partner, Jacqueline Alikhaani, Matthew Roe, Lisa Berdan, Holly Robertson, Amber Sharlow, Brad Hammill, Debra Harris, Laura Qualls, Hillary Mulder, Lisa Wruck, Michael Pencina, Guillaume Marquis-Gravel, Clyde Yancy, Dave Demets, Judith Hochman, Bernard Gersh, Alice Jacobs, Debbe McCall, Hugo Campos, Desiree Davidson, Kevin Edgley, Greg Merritt, Linda Brown, Henry Cruz, Nadine Zemon, Tom McCormick, Ken Gregoire, Abel Kho, Russ Waitman, Veronique Roger, Rainu Kaushal, Elizabeth Shenkman, Kathleen McTigue, Douglas Bell, Thomas Carton, A Kho, M Nodal, D Fintel, F Ahmad, A Williams, R C Shah, A Flores, M Jansen, T Polonsky, D Hood, J French, P Dexter, D Riley, N Smith, S Girotra, R Waitman, S Chandaka, T McMahon, K Greening, Y Murr, K Munshi, H Sandoval, K Gupta, L Verhagen, T Foss, J VanWormer, K Osinski, A Schwarz, S Cornell, M Berendt, J Whittle, A Mosa, V Mandhadi, L Lawrence, A Kumar, D Mehr, J McClay, P Guda, A Wolfe, C Geary, K Ostlund, L Larson, R Harper, J Campbell, L Manuel, O Suarez, J Polanco, A Tirado-Ramos, S Tsai, J Cai, M Bell, P Reeder, T Bosler, K Wilkinson, S Antony, S Das, K Hanson, C Rodgers, E Ebere, S Bradley, M Miedema, R Thiel, B Lemke, I Haller, C Benziger, S Rea, D Ward, H Maestas, N Garbe, L Evans, P Haug, K Knowlton, V Roger, E Koepsell, S Brue, J Bauman, B Bucknell, H Jouni, M Jindra, J Harper, M Bright, B Lampert, S Fernandez, J Ryan, S Brougher, M Harris, A Fishstom, L Ferguson, D Braswell, K Shah, B Nallamothu, C Friedman, D Williams, P Farrehi, W S Jones, J Curtis, J Hamill, B O'Brien, M B Summers, X Idriss, W Pohlman, K Thompson, D Dewalt, R Bradford, T Barber, D Crenshaw, K Goggins, W Hucke, S Kripalani, S McCrate, J Moore, D Muñoz, C O'Donnell, C Pritchett, C Roumie, R Servis, K Worley, J Borgman, L Doomy, K Blinson, G Rosenthal, L Zhou, O A Sandu, Y Goldberg, E Fass, D McKee, J Lin, C Pulgarin, S Blecker, R Kaushal, A Cohen, N Goldberg, S Chaudhary, A LaMar, T Haque, K LaScalea, R Kim, T Campion, B Shenkman, B Roth, D Bright, J Hensley, T Chou, J-A Norton, C Garrett, C Pepine, D Anderson, E Handberg, B Johnson, T Robinson, D Allen, M Warrington, H Seifein, H Noel, V K Kasi, D Gumas, H Lehmann, M Gauvey-Kern, D Ford, T Metkus, J McCullough, K Confer, C Chuang, J Kraschnewski, M Weiner, J Turella, A Paranjape, K McTigue, N Cappella, P Kant, A Arita, E Klawson, S Jain, A Huffman, C Moynier, T Greimes, B Steinberg, R Hess, M Zachariah, D Bell, G Fonarow, T Carton, B Nauman, L Rudov, L Hall, L Clariday, R Baker, P McCullough, C Parke, D Rachal, R Jenkins, S Cohen, G Liu, M Effron, R Re, A Irimpen, M Pletcher, M Faulkner, M Cziraky, Q Shi, A Marshall, E R Kennedy, K Haynes, V Nair

Affiliation

¹ From Duke Clinical Research Institute, Duke University, Durham (W.S.J., H.M., L.M.W., M.J.P., M.T.R., H.R.R., L.H.C., A.G.S., L.G.B., B.G.H., D.F.H., L.G.Q., G.M.-G., A.F.H.), University of North Carolina at Chapel Hill, Chapel Hill (D.A.D.), and Wake Forest University School of Medicine, Winston-Salem (L.Z.) - all in North Carolina; Vanderbilt University Medical Center, Nashville (S.K., D.M., D.L.C., R.L.R.); Ochsner Health (M.B.E., R.N.R.) and Louisiana Public Health Institute (T.W.C., E.N.) - both in New Orleans; University of Kansas Medical Center, Kansas City (K.G.); University of Florida, Gainesville (R.D.A., C.J.P., E.M.H., B.R.M., E.A.S.); University of Pittsburgh Medical Center, Pittsburgh (S.K.J., K.M.M.), Penn State College of Medicine, Hershey (J.L.K.), and Temple University, Philadelphia (A.P.) - all in Pennsylvania; University of Iowa, Iowa City (S.G., D.R.); Medical College of Wisconsin, Milwaukee (J.W.), and Marshfield Clinic Research Institute, Marshfield (J.J.V.) - both in Wisconsin; Albert Einstein College of Medicine, Bronx (Y.H.G.), and Weill Cornell Medicine and New York-Presbyterian Hospital, New York (R.K.) - both in New York; Mayo Clinic, Rochester (V.L.R.), Essentia Health Heart and Vascular Center, Duluth (C.P.B.), and Allina Health and Minneapolis Heart Institute, Minneapolis (S.M.B.) - all in Minnesota; University of Utah School of Medicine (R.H.) and Intermountain Medical Center Heart Institute (K.U.K.) - both in Salt Lake City; University of Michigan, Ann Arbor (P.F.); Johns Hopkins University School of Medicine, Baltimore (D.E.F.); HealthCore, Wilmington, DE (K.H.); University of Chicago Medicine (T.S.P.) and Northwestern University Feinberg School of Medicine (D.J.F., F.S.A., A.M.K.) - both in Chicago; University of Nebraska Medical Center, Omaha (J.C.M., J.R.C.); University of California, Los Angeles, Los Angeles (D.S.B., G.C.F.), University of California, San Francisco, San Francisco (M.F.M., G.M.M.), and Stanford University School of Medicine, Stanford (R.A.H.) - all in California; University of Missouri School of Medicine, Columbia (L.R.W.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (F.A.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.M.A.); Chicago (D.R.D.); St. Joseph, MO (K.E.); Brighton, MI (J.G.M.); Columbia, TN (L.S.B.); Alachua, FL (D.N.Z.); Columbia, MD (T.E.M.); North Hills, CA (J.D.A.); and Metairie, LA (K.C.G.).

PMID: 33999548
PMCID: PMC9908069
DOI: 10.1056/NEJMoa2102137

Abstract

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.).

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Figures

**Figure 1.. Time-to-Event Curves for the Primary Effectiveness Outcome and Primary Safety Outcome, According to Randomized Treatment Group.**
Panel A shows the cumulative incidence of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke (primary effectiveness outcome). Panel B shows the cumulative incidence of hospitalization for major bleeding that was associated with a blood-product transfusion (primary safety outcome). In each panel, the inset shows the same data on an enlarged y axis.

See this image and copyright information in PMC

Comment in

Pragmatic Trials - Need for ADAPTABLE Design.
Baigent C. Baigent C. N Engl J Med. 2021 May 27;384(21):2065-2066. doi: 10.1056/NEJMe2106430. Epub 2021 May 15. N Engl J Med. 2021. PMID: 33999542 No abstract available.
Aspirin dosing for secondary prevention in ASCVD.
Fernández-Ruiz I. Fernández-Ruiz I. Nat Rev Cardiol. 2021 Aug;18(8):544. doi: 10.1038/s41569-021-00576-7. Nat Rev Cardiol. 2021. PMID: 34040183 No abstract available.
Are US cardiologists ADAPTABLE to considering low-dose aspirin for secondary prevention?
Liuzzo G, Patrono C. Liuzzo G, et al. Eur Heart J. 2021 Jul 8;42(26):2525-2526. doi: 10.1093/eurheartj/ehab357. Eur Heart J. 2021. PMID: 34172997 No abstract available.
Aspirin Dosing in Cardiovascular Disease.
Monach PA, Branch-Elliman W. Monach PA, et al. N Engl J Med. 2021 Aug 19;385(8):764. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407351 No abstract available.
Aspirin Dosing in Cardiovascular Disease.
Sacristán JA. Sacristán JA. N Engl J Med. 2021 Aug 19;385(8):764. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407352 No abstract available.
Aspirin Dosing in Cardiovascular Disease.
Javor E, Skelin M, Lucijanić M. Javor E, et al. N Engl J Med. 2021 Aug 19;385(8):764-765. doi: 10.1056/NEJMc2110476. N Engl J Med. 2021. PMID: 34407353 No abstract available.
In ASCVD, 81 mg and 325 mg of aspirin did not differ for CV or bleeding events.
McCarthy L. McCarthy L. Ann Intern Med. 2021 Oct;174(10):JC118. doi: 10.7326/ACPJ202110190-118. Epub 2021 Oct 5. Ann Intern Med. 2021. PMID: 34606309

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Precision antiplatelet therapy.
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References

1. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics — 2020 update: a report from the American Heart Association. Circulation 2020;141(9): e139–e596. - PubMed
1. The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med 2018;379:1529–39. - PubMed
1. Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet 2018;392: 1036–46. - PMC - PubMed
1. McNeil JJ, Wolfe R, Woods RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med 2018;379:1509–18. - PMC - PubMed
1. Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373:1849–60. - PMC - PubMed

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[1] Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics — 2020 update: a report from the American Heart Association. Circulation 2020;141(9): e139–e596. - PubMed

[2] Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics — 2020 update: a report from the American Heart Association. Circulation 2020;141(9): e139–e596. - PubMed

[3] The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med 2018;379:1529–39. - PubMed

[4] The ASCEND Study Collaborative Group. Effects of aspirin for primary prevention in persons with diabetes mellitus. N Engl J Med 2018;379:1529–39. - PubMed

[5] Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet 2018;392: 1036–46. - PMC - PubMed

[6] Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet 2018;392: 1036–46. - PMC - PubMed

[7] McNeil JJ, Wolfe R, Woods RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med 2018;379:1509–18. - PMC - PubMed

[8] McNeil JJ, Wolfe R, Woods RL, et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Engl J Med 2018;379:1509–18. - PMC - PubMed

[9] Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373:1849–60. - PMC - PubMed

[10] Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373:1849–60. - PMC - PubMed

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Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

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Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease

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