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Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.

Publication ,  Journal Article
Lopes, RD; Heizer, G; Aronson, R; Vora, AN; Massaro, T; Mehran, R; Goodman, SG; Windecker, S; Darius, H; Li, J; Averkov, O; Bahit, MC ...
Published in: N Engl J Med
April 18, 2019

BACKGROUND: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. METHODS: In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. RESULTS: Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group. CONCLUSIONS: In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 18, 2019

Volume

380

Issue

16

Start / End Page

1509 / 1524

Location

United States

Related Subject Headings

  • Vitamin K
  • Pyridones
  • Pyrazoles
  • Purinergic P2Y Receptor Antagonists
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage
 

Citation

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Lopes, R. D., Heizer, G., Aronson, R., Vora, A. N., Massaro, T., Mehran, R., … AUGUSTUS Investigators, . (2019). Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med, 380(16), 1509–1524. https://doi.org/10.1056/NEJMoa1817083
Lopes, Renato D., Gretchen Heizer, Ronald Aronson, Amit N. Vora, Tyler Massaro, Roxana Mehran, Shaun G. Goodman, et al. “Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.N Engl J Med 380, no. 16 (April 18, 2019): 1509–24. https://doi.org/10.1056/NEJMoa1817083.
Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, et al. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509–24.
Lopes, Renato D., et al. “Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.N Engl J Med, vol. 380, no. 16, Apr. 2019, pp. 1509–24. Pubmed, doi:10.1056/NEJMoa1817083.
Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH, AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509–1524.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 18, 2019

Volume

380

Issue

16

Start / End Page

1509 / 1524

Location

United States

Related Subject Headings

  • Vitamin K
  • Pyridones
  • Pyrazoles
  • Purinergic P2Y Receptor Antagonists
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Middle Aged
  • Male
  • Humans
  • Hemorrhage