Key result
Apixaban did not meet prespecified noninferiority criteria compared with enoxaparin for thromboprophylaxis after knee replacement (9.0% vs 8.8%; RR 1.02; 95% CI 0.78-1.32).
Why the study?
Does apixaban reduce the composite of deep-vein thrombosis, pulmonary embolism, and death compared to enoxaparin in patients undergoing total knee replacement?
Population
3195 patients undergoing total knee replacement
Comparison
Apixaban 2.5 mg orally twice daily, started 12… vs Enoxaparin 30 mg subcutaneously every 12 hours…
Design
RCT, randomly assigned, double-blind, double-dummy
Follow-up
10 to 14 days of treatment, followed for 60 days
Authors
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Apixaban is not noninferior to enoxaparin for post-knee replacement thromboprophylaxis; do not adopt and pursue alternative regimens in future trials.
RCT (n=3,195)
Double-blind, double-dummy
Does apixaban reduce the composite of deep-vein thrombosis, pulmonary embolism, and death compared to enoxaparin in patients undergoing total knee replacement?
Effect estimate: RR 1.02 (95% CI 0.78 to 1.32)
Absolute Event Rate: 9% vs 8.8%
Apixaban did not meet noninferiority criteria for thromboprophylaxis efficacy compared to enoxaparin after knee replacement, but resulted in less bleeding.
Lassen et al. (2009) conducted an RCT in Total knee replacement (n=3,195). Apixaban vs. Enoxaparin 30 mg subcutaneously every 12 hours was evaluated on Composite of asymptomatic and symptomatic deep-vein thrombosis, nonfatal pulmonary embolism, and death from any cause during treatment (RR 1.02, 95% CI 0.78 to 1.32). Apixaban did not meet prespecified noninferiority criteria compared with enoxaparin for thromboprophylaxis after knee replacement (9.0% vs 8.8%; RR 1.02; 95% CI 0.78-1.32).
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