A randomized, parallel, open-label AFIRE trial with the goal to evaluate rivaroxaban monotherapy compared with rivaroxaban/antiplatelet therapy among patients with atrial fibrillation and stable coronary artery disease. Patients with atrial fibrillation and stable coronary artery disease were randomized to rivaroxaban 15 mg daily vs. rivaroxaban/antiplatelet therapy. 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. 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.

Secondary outcomes:

  1. All-cause death: 1.9%/patient-year of the rivaroxaban monotherapy group compared with 3.4%/patient-year of the rivaroxaban/antiplatelet therapy group

  2. Cardiovascular death: 1.2%/patient-year of the rivaroxaban monotherapy group compared with 2.0%/patient-year of the rivaroxaban/antiplatelet therapy group 

  3. Primary outcome for rivaroxaban monotherapy versus rivaroxaban/antiplatelet therapy among those who underwent PCI <2 years before enrollment: hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.66-2.50, and among those who underwent PCI ≥2 years before enrollment

  4. Major bleeding for rivaroxaban monotherapy versus rivaroxaban/antiplatelet therapy among those who underwent PCI <2 years before enrollment: HR 0.72, 95% CI 0.30-1.74, and among those who underwent PCI ≥2 years before enrollment

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

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Source

https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2019/09/01/11/05/AFIRE

Tags

Disease Condition ,Coronary Artery Disease,Arrhythmias,Acute Coronary Syndrome,Myocardial Infarction,Ischemic Heart Disease,Atrial Fibrillation