Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin
Authors: Amit N. Vora, John H. Alexander, Daniel M. Wojdyla, Ronald Aronson, Christopher B. Granger, Harald Darius, Stephan Windecker, Roxana Mehran, Oleg Averkov, Andrzej Budaj, David F. Kong, Zhanna Kobalava, Rajendra H. Mehta, Zulfiqar Mirza, Patricia Oliveira Guimaraes, Alexander Parkhomenko, Alexandre Quadros, Holger Thiele, Shaun G. Goodman, Renato D. Lopes
Journal: Circulation (2019)

atrial fibrillation ◼ hospitalization ◼ percutaneous coronary intervention ◼ platelet aggregation inhibitors T he optimal antithrombotic therapy among patients with atrial fibrillation who present with acute coronary syndrome (ACS) or require percutaneous coronary intervention (PCI) can be challenging, with combination therapy, including both dual antiplatelet therapy and oral anticoagulation, markedly increasing bleeding risk. 1 Recent trials with rivaroxaban 2 and dabigatran 3 have demonstrated the safety of using a non-vitamin K oral anticoagulant with a P2Y 12 inhibitor, without aspirin or with reduced-dose aspirin, after PCI.The AU-GUSTUS trial (Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention) demonstrated that apixaban resulted in less bleeding than vitamin K antagonist (VKA), with lower rates of the composite of death or all-cause hospitalization. 4Rates of bleeding were higher among patients treated with aspirin than those treated with placebo, but rates of death or all-cause hospitalization were not different.This analysis evaluated rates and causes of hospitalization, a key secondary outcome, overall and by randomized treatment.The rationale and design of the AUGUSTUS trial have been published. 5Briefly, AUGUSTUS was a prospective, multicenter, 2×2 factorial trial that randomized patients with atrial fibrillation and recent ACS or PCI to apixaban or VKA and to aspirin or placebo for 6 months on background P2Y 12 inhibitor.The primary end point for the study was major or clinically relevant nonmajor bleeding as defined by the International Society on Thrombosis and Haemostasis.Hospitalizations were classified as cardiovascular, bleeding related, or other cause by reviewers blinded to treatment assignment.The trial protocol was approved by appropriate ethics committees at participating sites, and all patients provided written informed consent before participation in the study.All patients randomized are included and analyzed according to the intent-totreat principle.Events were counted from the time of randomization through the 6-month visit.Hazard ratios were derived from Cox proportional hazard models using the time to the first cause-specific hospitalization.The incidence of myocardial infarction, International Society on Thrombosis and Haemostasis major bleeding, and all-cause death after bleeding-related hospitalizations are reported as frequencies and percentages of patients in patients discharged alive.Bleeding-related hospitalizations occurring within 7 days after another hospitalization are excluded from this analysis.A total of 4614 patients from 492 sites in 33 countries were randomized.The median age was 71 years, and 29% were women.Thirty-seven percent had an ACS and underwent PCI; 24% had medically managed ACS; and the remaining 39% underwent elective PCI.The mean CHA 2 DS 2 -VASc score was 3.9 (SD, 1.6), and the mean HAS-BLED score was 2.9 (SD, 0.9).Clopidogrel was the P2Y 12 inhibitor of choice in 93% of patients.