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RE-LY Dabigatran 110 mg twice per day 150 mg twice per day 2.1 40 All stroke and systemic embolism Reduction in hemoglobin of at least 2 g/dL [20 g/L] or symptomatic bleeding in critical organ

ARISTOTLE Apixaban 5 mg twice per day ◊ 2.1 31 All stroke and systemic embolism Overt bleeding plus fall in hemoglobin of at least 2 g/dL [20 g/L] or transfusion of 2 units of packed red blood cells, occurring at a critical site, or resulting in death Outcome event rates (percent/yr) (new agent/warfarin) Primary outcome Major bleeding Death Stroke (all) Stroke (hemorrhagic) Percent time in INR range

ARISTOTLE 1.27/1.60 (B) 2.13/3.09 (C) 3.52/3.94 (C) 1.19/1.51 0.24/0.47 (C) 62 CHADS 2 : estimate of stroke risk (see UpToDate topic "Risk of embolization in atrial fibrillation"); (A): statistically significant for noninferiority; (B): statistically significant for superiority; (C): statistically significant. * Target INR 2.0 to 3.0 in each study. • Mean follow up of approximately two years in each study. Δ Dose of rivaroxaban adjusted to 15 mg per day for renal insufficiency (creatinine clearance 30 to 49 mL/minute [0.5 to 0.82 mL/second]). ◊ Dose of apixaban adjusted to 2.5 mg twice per day with two or more of: age ≥80 years, body weight ≤60 kg, or renal insufficiency (serum creatinine level ≥1.5 mg/dL [133 µmol/L]). References: Connolly SJ, Ezekowitz MD, Eikelbloom YS, et al. Dabigatran versus warfarin in patients with atrial fibrillation; N Engl J Med 2009; 361:1139. Patel MR, Mahaffey KE, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation; N Engl J Med 2011; 365:883. Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation; N Engl J Med 2011; 365:981.