XARELTO®: Clinical trial and real-world evidence in stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF)
Extensive evidence of stroke risk reduction in patients with NVAF1-3
Trial design: A randomized, phase 3, multicenter, active-controlled, double-blind, double-dummy, event-driven study. Patients received XARELTO® 20 mg once daily (15 mg once daily in patients with moderate renal impairment defined as CrCl 30 mL/min to 49 mL/min) (n=7131) or dose-adjusted warfarin (n=7133) titrated to an INR range of 2.0 to 3.0.
Study endpoints: The primary efficacy endpoint was stroke (ischemic or hemorrhagic) and SE. The principal safety endpoint was a combination of major bleeding and clinically relevant nonmajor bleeding events.
ROCKET AF Post Hoc Obesity Analysis2
Study design: Post hoc analysis of the ROCKET AF trial where patients were grouped according to BMI: 18.50 kg/m2 to 24.99 kg/m2 (n=3289); 25.00 kg/m2 to 29.99 kg/m2 (n=5535); ≥30 kg/m2 (n=5206).
Study endpoints: The primary efficacy endpoint was the composite of stroke and SE. Secondary efficacy endpoints were stroke and ischemic stroke. The principal safety endpoint was the composite of major and nonmajor clinically relevant bleeding events.
NVAF and Morbid Obesity Real-World Study3
Study design: Retrospective cohort study using data from the Truven MarketScan Commercial Claims and Encounters and Medicare Supplemental databases from December 1, 2010, through December 31, 2016. Patients were identified who were initiated on XARELTO® or warfarin (first pharmacy claim date was the index date), who had ≥1 medical claim with an AF diagnosis during the past 12 months prior to or on the index date, and ≥1 medical claim for morbid obesity. Patients were required to have continuous enrollment 12 months before index date and at least 3 months after treatment initiation. Patients receiving XARELTO® or warfarin were 1:1 propensity score matched.
Study endpoints: The primary outcome was the composite risk of ischemic stroke and SE. Secondary outcomes included major bleeding risk.
AF = atrial fibrillation; BMI = body mass index; CrCl = creatinine clearance; INR = international normalized ratio; N/A = not applicable; NVAF = nonvalvular atrial fibrillation; SE = systemic embolism.