atrial fibrillation and stroke prevention - Continuing Medical ...

Essentials in Primary Care Conference
Wednesday, July 31, 2013
ROCKET AF Trial:
Rivaroxaban vs Warfarin
Nonvalvular AF,
history of stroke,
TIA, or embolism,
or at least 2 of the
following: HF,
HTN, age 75
years, or diabetes
mellitus
R
Day 1
Treatment period 12-32 months
Rivaroxaban 20 mg QD
Rivaroxaban 15 mg QD
(CrCl 30-49 mL/min at entry)
N = 14,269
Warfarin target INR, 2.5
(INR range, 2.0-3.0)
End of treatment
Follow-up
Day 30
after last dose
• Primary study endpoint: composite of all-cause stroke and non-CNS
systemic embolism
• Primary safety endpoint: composite of major and clinically relevant
nonmajor bleeding events
ROCKET = Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K
Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; CNS = central
nervous system.
Patel MR, et al. N Engl J Med. 2011;365(10):883-891.
Rivaroxiban vs Warfarin
Event Rate (%/year)
Efficacy Outcomes Rivaroxiban Warfarin
Stroke or Systemic Embolism
As-treated population 1.7 2.2
Intention-to-treat population 2.1 2.4
Hemorrhagic stroke 0.26 0.44
MI 0.91 1.12
Safety Outcomes
Major bleeding (Fatal) 0.2 0.5
ICH 0.5 0.7
0 0.50 1.00 1.50 2.00
Rivaroxiban Better Warfarin Better
Patel MR, et al. N Engl J Med. 2011;365(10):883-891.
Jan Basile, MD
Atrial Fibrillation & Stroke Prevention