Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial

Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892.

Abstract

Objective: Managing antithrombotic therapy in patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) is challenging and can be affected by prior oral anticoagulant (OAC) treatment. We examined the relationship between prior OAC use and outcomes in the AUGUSTUS trial.

Methods: This prespecified secondary analysis is from AUGUSTUS, an open-label, 2-by-2 factorial, RCT to evaluate the safety of apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo in patients with AF and ACS and/or PCI. The primary endpoint, major or clinically relevant non-major bleeding and clinical outcomes were compared in patients receiving (n=2262) or not receiving (n=2352) an OAC prior to enrolment.

Results: Patients with prior OAC use had more comorbidities, higher CHA2DS2-VASC and HAS-BLED scores, and were more likely enrolled following elective PCI. There was no difference in major or clinically relevant non-major bleeding with or without prior OAC (30 days: 5.1% vs 5.9% (adjusted HR (aHR) 0.82, 95% CI 0.63 to 1.06); 180 days: 13.5% vs 13.5% (aHR 0.98, 95% CI 0.83 to 1.16)). Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)). No interactions between randomised treatment (apixaban vs VKA, aspirin vs placebo) and prior OAC status were observed for outcomes, apart from apixaban (vs VKA) being associated with a lower risk of myocardial infarction with prior OAC use (180 days: 2.0% vs 3.7% (aHR 0.56, 95% CI 0.33 to 0.91().

Conclusions: In AUGUSTUS, prior OAC use was associated with fewer ischaemic events but not more bleeding. In patients with AF and ACS and/or undergoing PCI, clinicians can be assured that the trial results can be applied to patients regardless of their prior OAC status.

Trial registration number: NCT02415400.

Keywords: acute coronary syndrome; atrial fibrillation; percutaneous coronary intervention.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome* / complications
  • Acute Coronary Syndrome* / drug therapy
  • Aspirin* / adverse effects
  • Aspirin* / therapeutic use
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy
  • Factor Xa Inhibitors / adverse effects
  • Factor Xa Inhibitors / therapeutic use
  • Female
  • Hemorrhage / epidemiology
  • Hemorrhage / etiology
  • Humans
  • Ischemia / etiology
  • Ischemia / prevention & control
  • Male
  • Medication Therapy Management
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / methods
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Aggregation Inhibitors / therapeutic use
  • Preoperative Period*
  • Pyrazoles* / adverse effects
  • Pyrazoles* / therapeutic use
  • Pyridones* / adverse effects
  • Pyridones* / therapeutic use
  • Vitamin K / antagonists & inhibitors*

Substances

  • Factor Xa Inhibitors
  • Platelet Aggregation Inhibitors
  • Pyrazoles
  • Pyridones
  • Vitamin K
  • apixaban
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT02415400