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Hijazi Z, Alexander JH, Li Z, et al. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021;143(12):1215-1223doi: 10.1161/CIRCULATIONAHA.120.051020.
Hijazi, Z., Alexander, J. H., Li, Z., Wojdyla, D. M., Mehran, R., Granger, C. B., Parkhomenko, A., Bahit, M. C., Windecker, S., Aronson, R., Berwanger, O., Halvorsen, S., de Waha-Thiele, S., Sinnaeve, P., Darius, H., Storey, R. F., & Lopes, R. D. (2021). Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation, 143(12), 1215-1223. https://doi.org/10.1161/CIRCULATIONAHA.120.051020
Hijazi, Ziad, et al. "Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial." Circulation vol. 143,12 (2021): 1215-1223. doi: https://doi.org/10.1161/CIRCULATIONAHA.120.051020
Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19. PMID: 33461308.
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Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.

Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Circulation

Ziad Hijazi, John H Alexander, Zhuokai Li, Daniel M Wojdyla, Roxana Mehran, Christopher B Granger, Alexander Parkhomenko, M Cecilia Bahit, Stephan Windecker, Ronald Aronson, Otavio Berwanger, Sigrun Halvorsen, Suzanne de Waha-Thiele, Peter Sinnaeve, Harald Darius, Robert F Storey, Renato D Lopes

Affiliations

  1. Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Sweden (Z.H.).
  2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., Z.L., D.M.W., C.B.G., R.D.L.).
  3. Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).
  4. NSC Institute of Cardiology, Kyiv, Ukraine (A.P.).
  5. Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.).
  6. Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).
  7. Bristol-Myers Squibb, Lawrenceville, NJ (R.A.).
  8. Hospital Israelita Albert Einstein, São Paulo, Brazil (O.B.).
  9. Oslo University Hospital Ulleval, Norway (S.H.).
  10. University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.dW.-T.).
  11. German Center for Cardiovascular Research (DZHK), Lübeck (S.dW.-T.).
  12. University Hospitals Leuven, University of Leuven, Belgium (P.S.).
  13. Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).
  14. Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, United Kingdom (R.F.S.).

PMID: 33461308 DOI: 10.1161/CIRCULATIONAHA.120.051020

Abstract

BACKGROUND: In the AUGUSTUS trial (An Open-Label, 2×2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban Versus Vitamin K Antagonist and Aspirin Versus Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), apixaban resulted in less bleeding and fewer hospitalizations than vitamin K antagonists, and aspirin caused more bleeding than placebo in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention treated with a P2Y

METHODS: In 4456 patients, the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula was used to calculate baseline estimated glomerular filtration rate (eGFR). The effect of apixaban versus vitamin K antagonists and aspirin versus placebo was assessed across kidney function categories by using Cox models. The primary outcome was International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and ischemic events (death, stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization). Creatinine clearance <30 mL/min was an exclusion criterion in the AUGUSTUS trial.

RESULTS: Overall, 30%, 52%, and 19% had an eGFR of >80, >50 to 80, and 30 to 50 mL·min

CONCLUSIONS: The safety and efficacy of apixaban was consistent irrespective of kidney function, compared with warfarin, and in accordance with the overall trial results. The risk of bleeding with aspirin was consistently higher across all kidney function categories. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.

Keywords: acute coronary syndrome; anticoagulant; atrial fibrillation; fibrinolytic agents; kidney function tests

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