Ischaemic cardiac outcomes in patients with atrial fibrillation treated with vitamin K antagonism or factor Xa inhibition: results from the ROCKET AF trial

Eur Heart J. 2014 Jan;35(4):233-41. doi: 10.1093/eurheartj/eht428. Epub 2013 Oct 15.

Abstract

Aims: We investigated the prevalence of prior myocardial infarction (MI) and incidence of ischaemic cardiovascular (CV) events among atrial fibrillation (AF) patients.

Methods and results: In ROCKET AF, 14 264 patients with nonvalvular AF were randomized to rivaroxaban or warfarin. The key efficacy outcome for these analyses was CV death, MI, and unstable angina (UA). This pre-specified analysis was performed on patients while on treatment. Rates are per 100 patient-years. Overall, 2468 (17%) patients had prior MI at enrollment. 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. 39%), hypertension (94 vs. 90%), higher mean CHADS2 score (3.64 vs. 3.43), and fewer prior strokes or transient ischaemic attacks (46 vs. 54%). CV death, MI, or UA rates tended to be lower in patients assigned rivaroxaban compared with warfarin [2.70 vs. 3.15; hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.73-1.00; P = 0.0509]. CV death, MI, or UA rates were higher in those with prior MI compared with no prior MI (6.68 vs. 2.19; HR 3.04, 95% CI 2.59-3.56) with consistent results for CV death, MI, or UA for rivaroxaban compared with warfarin in prior MI compared with no prior MI (P interaction = 0.10).

Conclusion: Prior MI was common and associated with substantial risk for subsequent cardiac events. Patients with prior MI assigned rivaroxaban compared with warfarin had a non-significant 14% reduction of ischaemic cardiac events.

Keywords: Atrial fibrillation; Coronary artery disease; Factor Xa; Myocardial infarction; Outcomes; Rivaroxaban; Warfarin.

Publication types

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

MeSH terms

  • Aged
  • Anticoagulants / administration & dosage*
  • Aspirin / therapeutic use
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy*
  • Clopidogrel
  • Double-Blind Method
  • Embolism / prevention & control
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Morpholines / administration & dosage*
  • Myocardial Infarction / complications
  • Myocardial Infarction / drug therapy
  • Platelet Aggregation Inhibitors / therapeutic use
  • Pyridines / therapeutic use
  • Rivaroxaban
  • Stroke / prevention & control
  • Thiophenes / administration & dosage*
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • Treatment Outcome
  • Warfarin / administration & dosage*

Substances

  • Anticoagulants
  • Morpholines
  • Platelet Aggregation Inhibitors
  • Pyridines
  • Thiophenes
  • thienopyridine
  • Warfarin
  • Rivaroxaban
  • Clopidogrel
  • Ticlopidine
  • Aspirin