American College of Cardiology Foundation

09/02/2019 | Press release | Distributed by Public on 09/02/2019 04:19

Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease

Contribution To Literature:

The AFIRE trial showed that rivaroxaban monotherapy vs. rivaroxaban/antiplatelet therapy was noninferior for ischemia and superior for bleeding.

Description:

The goal of the trial was to evaluate rivaroxaban monotherapy compared with rivaroxaban/antiplatelet therapy among patients with atrial fibrillation and stable coronary artery disease.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with atrial fibrillation and stable coronary artery disease were randomized to rivaroxaban 15 mg daily (10 mg daily for creatine clearance 15-49 ml/min) (n = 1,118) vs. rivaroxaban/antiplatelet therapy (n = 1,118).

  • Total number of enrollees: 2,236
  • Duration of follow-up: 24 months
  • Mean patient age: 74 years
  • Percentage with diabetes: 42%

Inclusion criteria:

  • Patients ≥20 years of age with atrial fibrillation
  • Stable coronary artery disease (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] ≥1 year prior to enrollment or coronary stenosis ≥50% not requiring revascularization)

Exclusion criteria:

  • Stent thrombosis
  • Active malignancy
  • Poorly controlled hypertension

Other salient features/characteristics:

  • In the combination therapy group, 70% received aspirin, while 27% received a P2Y12 inhibitor as their antiplatelet agent.

Principal Findings:

The trial was terminated early due to excess mortality in the rivaroxaban/antiplatelet therapy group.

The primary efficacy outcome, all-cause mortality, myocardial infarction, stroke, unstable angina requiring revascularization, or systemic embolism, occurred in 4.1%/patient-year of the rivaroxaban monotherapy group compared with 5.8%/patient-year of the rivaroxaban/antiplatelet therapy group (p for noninferiority < 0.0001).

The primary safety outcome, major bleeding (ISTH criteria), occurred in 1.6%/patient-year of the rivaroxaban monotherapy group compared with 2.8%/patient-year of the rivaroxaban/antiplatelet therapy group (p = 0.01).

Secondary outcomes:

  • All-cause death: 1.9%/patient-year of the rivaroxaban monotherapy group compared with 3.4%/patient-year of the rivaroxaban/antiplatelet therapy group (p < 0.05)
  • Cardiovascular death: 1.2%/patient-year of the rivaroxaban monotherapy group compared with 2.0%/patient-year of the rivaroxaban/antiplatelet therapy group (p < 0.05)

Interpretation:

Among patients with atrial fibrillation and stable coronary artery disease, rivaroxaban monotherapy vs. rivaroxaban/antiplatelet therapy was noninferior for ischemia and superior for bleeding. To be eligible for this study, patients had to have a history of PCI or CABG at least 1 year prior or nonrevascularized coronary disease.

The WOEST, AF-PCI, RE-DUAL PCI, and AUGUSTUS trials have documented the safety of anticoagulation/mono-antiplatelet therapy (so-called 'dual therapy') in the first year after PCI.

The Danish registry, OAC-ALONE, and now this study documented the safety of anticoagulation monotherapy 1 year after PCI.

In summary, several lines of evidence now support that anticoagulation without antiplatelet therapy is safe in the long-term management of patients with atrial fibrillation and stable coronary artery disease.

References:

Yasuda S, Kaikita K, Akao M, et al., on behalf of the AFIRE Investigators. Antithrombotic Therapy for Atrial Fibrillation With Stable Coronary Disease. N Engl J Med 2019;Sep 2:[Epub ahead of print].

Editorial: Becker RC. Antithrombotic Therapy in Atrial Fibrillation and Coronary Artery Disease. N Engl J Med 2019;Sep 2:[Epub ahead of print].

Presented by Dr. Satoshi Yasuda at the European Society of Cardiology Congress, Paris, France, September 2, 2019.

Clinical Topics:Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Coronary Artery Disease

Keywords:ESC Congress, ESC 19, Angina, Unstable, Anticoagulants, Atrial Fibrillation, Arrhythmias, Cardiac, Aspirin, Coronary Artery Bypass, Coronary Artery Disease, Coronary Stenosis, Creatine, Embolism, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke


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