Liviu Klein, MD, MS
In patients with nonvalvular atrial fibrillation (AF) at moderate-to-high risk for stroke, how does rivaroxaban compare with warfarin for prevention of stroke or systemic embolism?
Randomized controlled trial (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation [ROCKET AF]). ClinicalTrials.gov NCT00403767.
Blinded (patients, clinicians, and outcome assessors).*
Median 590 days.
1178 centers in 45 countries.
14 264 adults ≥ 18 years of age (median age 73 y, 60% men, mean CHADS2 score 3.5) who had electrocardiography-documented nonvalvular AF and a history of stroke; transient ischemic attack; systemic embolism; or ≥ 2 of heart failure or left ventricular ejection fraction ≤ 35%, hypertension, age ≥ 75 years, and diabetes mellitus. Exclusion criteria included AF due to a reversible cause, hemodynamically significant mitral valve stenosis, need for anticoagulation other than for AF, stroke within 14 days, and treatment with aspirin > 100 mg/d.
Rivaroxaban, 20 mg/d or 15 mg/d in patients with creatinine clearance of 30 to 49 mL/min, plus warfarin placebo (n = 7131), or warfarin, adjusted to achieve a target international normalized ratio (INR) of 2.0 to 3.0, plus rivaroxaban placebo (n = 7133).
Primary efficacy outcome was a composite of stroke or systemic embolism. Primary safety outcome was a composite of major or nonmajor clinically relevant bleeding. Secondary efficacy endpoints included a composite of stroke, systemic embolism, cardiovascular death, or myocardial infarction; and individual components of the composite outcomes.
The main results are in the Table.
In patients with nonvalvular atrial fibrillation, rivaroxaban reduced stroke and systemic embolism compared with warfarin.
†CV = cardiovascular; MI = myocardial infarction; other abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from hazard ratios and control event proportions in article.
‡Stroke (RRR 15%, CI −3 to 30), systemic embolism (RRR 77%, CI 39 to 91), CV death (RRR 11%, CI −10 to 27), MI (RRR 19%, CI −6 to 37).
Klein L. Rivaroxaban reduced stroke and systemic embolism compared with warfarin in nonvalvular AF. Ann Intern Med. ;156:JC1–3. doi: 10.7326/0003-4819-156-2-201201170-02003
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Published: Ann Intern Med. 2012;156(2):JC1-3.
Cardiology, Neurology, Prevention/Screening, Rhythm Disorders and Devices, Stroke.
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