Abstract 13482: Ischemic Cardiac Outcomes in Patients with AF Treated with Vitamin K Antagonism or Factor Xa Inhibition: Results from the ROCKET AF Trial
Background: Coronary artery disease is common in patients with atrial fibrillation (AF). We investigated the prevalence of prior myocardial infarction (MI) and incidence of future ischemic cardiovascular (CV) events among patients with AF who were enrolled in a large, international clinical trial comparing warfarin with rivaroxaban, a novel factor Xa inhibitor.
Methods: In ROCKET AF, 14,264 patients with nonvalvular AF were randomized to rivaroxaban or warfarin. The primary efficacy outcome was stroke or systemic embolism; secondary outcomes included CV events. This post-hoc analysis was performed on patients while on treatment. All events were adjudicated by a clinical events committee. Rates are per 100-pt years.
Results: Overall, 2460 (17%) patients had prior MI. Compared with patients without prior MI, these patients were more likely to be male (75% vs 57%), on aspirin at baseline (47% vs 34%), have prior congestive heart failure (78% vs 59%), diabetes (47% vs 34%), hypertension (94% vs 90%), higher mean CHADS score (3.64 vs 3.43) and fewer prior strokes (49% vs 56%). The rate of CV death, MI or unstable angina (UA) tended to be lower in patients assigned rivaroxaban compared with warfarin (2.70 vs 3.15, HR 0.86 95% CI (0.73, 1.00) (Table). Rates for CV death, MI or UA were higher in patients with prior MI compared with no prior MI (6.68 vs 2.19, HR 3.04, 95% CI (2.59, 3.56) with consistent efficacy results of rivaroxaban compared with warfarin in prior MI patients compared with patients without prior MI (p-interaction 0.10) .
Conclusions: In a global trial population of patients with AF, patients with prior MI are common and at substantial risk for subsequent cardiac and cerebrovascular events. While taking study medication, patients assigned rivaroxaban compared with warfarin had fewer ischemic cardiac events. The ongoing large ATLAS-ACS 2 trial is testing the safety and efficacy of rivaroxaban in patients with acute coronary syndromes.
- © 2011 by American Heart Association, Inc.