Oral Apixaban Lowers Rates of Major Bleeding in Patients with Acute Venous Thromboembolism
Single-agent apixaban (Eliquis) may simplify the treatment of patients with acute venous thromboembolism, according to a new study published online in The New England Journal of Medicine. In the phase III AMPLIFY trial, the oral factor Xa inhibitor anticoagulant was found to be as effective as the current standard of care for venous thromboembolism and was associated with a clinically relevant reduction of 69% in major bleeding.
Study Details
In a randomized, double-blind, multicenter trial, investigators compared fixed-dose apixaban (10 mg daily for 7 days followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin followed by warfarin) in 5,395 patients with acute venous thromboembolism. Approximately one-third of patients in the trial had a pulmonary embolism at the time of enrollment.
The primary efficacy endpoint of the trial was recurrent symptomatic venous thromboembolism or venous thromboembolism–related death, and the primary safety outcomes were major bleeding alone or major bleeding plus clinically relevant nonmajor bleeding.
Outcomes
Apixaban was found to be noninferior to conventional therapy for recurrent symptomatic venous thromboembolism or venous thromboembolism–related death, with the primary efficacy outcome occurring in 59 patients (2.3%) in the apixaban group vs 71 (2.7%) in the conventional therapy group (relative risk = 0.84, 95% confidence interval [CI] = 0.60–1.18, P < .0001 for noninferiority).
Major bleeding occurred in 0.6% of patients given apixaban and 1.8% of those given conventional therapy (relative risk = 0.31, 95% CI = 0.17–0.55, P < .0001 for superiority). The composite outcome of major bleeding and clinically relevant nonmajor bleeding occurred in 4.3% and 9.7% of patients in the apixaban and conventional therapy groups, respectively (relative risk = 0.44, 95% CI = 0.36–0.55, P < .001). Rates of other adverse events were similar in the two groups.
The trial demonstrated a comparable efficacy and safety profile between patients entering the study with deep-vein thrombosis and/or pulmonary embolism. In patients with deep-vein thrombosis, the primary efficacy outcome occurred in 2.2% of patients in the apixaban group and 2.7% of patients in the conventional therapy group. In patients who had pulmonary embolism at enrollment, the primary efficacy outcome occurred in 2.3% of patients in the apixaban group and 2.6% of patients in the conventional therapy group.
Potential Alternative Venous Thromboembolism Treatment
“The study results showed that apixaban, as a single-agent, has comparable efficacy with significantly fewer major bleeding events with respect to the standard of care. These results complement the previously published results for the AMPLIFY-EXT study,” said lead investigator Giancarlo Agnelli, MD, Professor of Internal Medicine, University of Perugia, Italy, in a press release. “Together these studies represent exciting data in the field of [venous thromboembolism] treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for [venous thromboembolism] patients.”
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