Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders

First Published, Prospective, International, Observational Study of a NOAC in NVAF Patients1

Objective

  • Evaluate major bleeding and stroke or systemic embolism in NVAF patients in real world clinical settings, ranging from primary care practices to cardiologists’ offices and hospitals1

Study design

  • A large, prospective, observational, single-arm, non-interventional study to evaluate the safety and efficacy of Xarelto® in the real world1
  • Patients were enrolled from June 2012 to December 2013 from 311 centres in Europe, Canada and Israel1

Population

  • 6,784 adults with NVAF newly receiving once-daily Xarelto for prevention of stroke and systemic embolism for NVAF were followed for 1 year, or 30 days following permanent treatment discontinuation1

XANTUS: CHADS2-scores

Xantus

AF, atrial fibrillation; CHF, congestive heart failure; CrCl, creatinine clearance; LVEF, left ventricular ejection fraction; NVAF, non-valvular atrial fibrillation; TIA, transient ischaemic attack. CHADS2-score is used to estimate stroke risk in patients with NVAF. Or LVEF <40%. † For Xantus patients, figure related to only age >75 years old. ‡ For Xantus patients, this also could have included prior systemic embolism. ‖ 34.4% of patients had unknown CrCl values. ¶ Moderate to severe renal impairment was defined as CrCl <50 ml/min in Xantus. ** Xarelto is only approved for stroke prevention in NVAF patients with one or more risk factors.

  • Xarelto is evidenced across the full CHADS2-scores risk spectrum.1,2
    XANTUS real world evidence reflects the patients seen frequently in general practice.

 

PP-XAR-ALL-1818-1

References