RCT Data: Efficacy and Safety in SPAF

Apixaban demonstrated consistent benefits across patients with NVAF with a wide range of stroke risks versus warfarin^1,5-7,*
 

Adapted from Granger CB, et al. 2011.
​​​​​​​

​​​​​​​Adapted from Lopes RD, et al. 2012.
 

Adapted from Lopes RD, et al. 2012.

Safety in SPAF

Apixaban demonstrated a favourable safety profile across components of major bleeding versus warfarin^1,5 
 

Adapted from Granger CB, et al. 2011; Conolly SJ, et al. 2011.

*As assessed by the CHADS₂, CHA₂DS₂-VASc and HAS-BLED scores,⁷ stroke or SE was the primary efficacy endpoint and major bleeding was the primary safety endpoint of the ARISTOTLE trial.¹ 

^†The ARISTOTLE trial was not designed or powered to detect interactions between study drug and CHA₂DS₂-VASc score
subgroups.^1,7

^‡Apixaban was studied in a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients.¹ Stroke/SE was the primary efficacy endpoint and major bleeding was the primary safety endpoint.¹ Intracranial bleeding and major bleeding at other locations including GI bleeding were components of the primary safety endpoint.¹ The endpoints presented were selected due to their frequency and severity: intracranial bleeding, the most feared complication of anticoagulation therapy due to its high risk of death and disability⁸; and GI bleeding, the most frequent adverse event associated with OAC use.^9-11

AF, atrial fibrillation; ARISTOTLE, Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation; AVERROES, Apixaban Versus Acetylsalicylic Acid to Prevent Strokes; CI, confidence interval; CHA₂DS₂, Congestive Heart Failure; CHA₂DS₂-VASc, Congestive Heart Failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular Disease, Age 65-74, Sex Category, Female; GI- gastrointestinal; HR, hazard ratio; Hypertension, Age ≥75, Diabetes, Stroke (doubled); ICH, intracerebral hemorrhage; NOAC, non-vitamin K antagonist oral anticoagulants; NVAF, nonvalvular atrial fibrillation; OAC, oral anticoagulant; PCI, percutaneous coronary intervention; ISTH, International Society on Thrombosis and Haemostasis; NOAC, non-vitamin K antagonist oral anticoagulants; NVAF, nonvalvular atrial fibrillation; RRR, relative risk reduction; SE, systemic embolism; SPAF, stroke prevention in patients with atrial fibrillation VKA, vitamin K antagonists.

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