Key result
Apixaban was non-inferior to conventional therapy for preventing recurrent venous thromboembolism or VTE-related death at 6 months (RR 0.84, p<0.001 for non-inferiority), with no excess of early recurrences and a reduced risk of major bleeding.
Why the study?
Does oral apixaban prevent recurrent VTE and reduce bleeding compared to enoxaparin followed by warfarin in patients with symptomatic proximal deep-vein thrombosis or pulmonary embolism?
RCT (n=5,395)
Double-blind
Randomized
Yes
Does oral apixaban prevent recurrent VTE and reduce bleeding compared to enoxaparin followed by warfarin in patients with symptomatic proximal deep-vein thrombosis or pulmonary embolism?
Relative Risk: 0.84 (95% CI 0.6–1.18)
Absolute Event Rate: 2.3% vs 2.7%
p-value: p=<0.001 for non-inferiority
Apixaban provides non-inferior efficacy for VTE treatment without an excess of early recurrences and significantly reduces major bleeding compared to conventional therapy, with benefits emerging early in the treatment course.
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Supports apixaban preference for acute VTE to minimize major bleeding; confirms non-inferior efficacy versus conventional therapy in pivotal RCT.
Gallus et al. (2015) conducted an RCT in Acute symptomatic proximal deep-vein thrombosis or pulmonary embolism (n=5,395). Apixaban vs. Enoxaparin followed by warfarin was evaluated on Composite of recurrent symptomatic VTE or death related to VTE (RR 0.84, 95% CI 0.60-1.18, p=<0.001 for non-inferiority). Apixaban was non-inferior to conventional therapy for preventing recurrent venous thromboembolism or VTE-related death at 6 months (RR 0.84, p<0.001 for non-inferiority), with no excess of early recurrences and a reduced risk of major bleeding.
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