Retrospective Real-World NOAC Study

Safety in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
, Reaffirmed in the Real World in the PMSS PMSS
Post-marketing safety surveillance.
Study of the US DoD DoD
Department of Defense.


  • Evaluate major bleeding in NVAF patients treated with Xarelto in a real world setting1

Study design

  • An ongoing 5-year US PMSS study to evaluate major bleeding in patients receiving Xarelto® in a real world clinical setting1
  • In the first published analysis of this US PMSS study, cases of major bleeding were identified through analysis of the US Department of Defense database, from 1 January 2013 to 31 March 20141


  • 27,467 patients receiving Xarelto for NVAF were followed for 455 days1

Key findings

  • In the US PMSS study, the incidence of major bleeding was 2.86%/YR YR
    , demonstrating general consistency with the ROCKET AF AF
    Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
    • 496 major bleeding events were identified during this study1
  • Bleeding types were generally consistent with ROCKET AF and fatal bleeding was rare1,2
    • 423 patients experienced major GI GI
    • 14 patients with major bleeding had a fatal outcome1


  • This is a retrospective study1
  • There is no comparator arm in the study1
  • Differences in study design, patient populations, major bleeding definitions and data collection methods make comparisons with clinical trials difficult1