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Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism
1. Recurrent VTE occurred in 2.1% in the reduced-dose group and 2.8% in the full-dose group, with HR 0.76 (was noninferior).
2. Clinically relevant bleeding occurred in 12.1% in the reduced-dose group and 15.6% in the full-dose group, with HR 0.75 (significant for superiority).
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with cancer are at increased risk for venous thromboembolism (VTE) and have higher rates of recurrence and complications during anticoagulant therapy compared to those without cancer. The optimal long-term dosing strategy remains unclear due to limited trial data. This trial evaluated whether a reduced dose of apixaban is noninferior to a full dose for preventing recurrent VTE. The primary endpoint was recurrent VTE over a 12-month follow-up period, and secondary endpoints included clinically relevant bleeding over the same time frame and other composite outcomes. Through the study, recurrent VTE occurred in 2.1% of the reduced-dose group and 2.8% of the full-dose group, with HR 0.76 (noninferior). Clinically relevant bleeding occurred in 12.1% in the reduced-dose group and 15.6% in the full-dose group, with HR 0.75 (significant for superiority). Major bleeding occurred in 2.9% in the reduced-dose group and 4.3% in the full-dose group, with HR 0.66 (non-significant). Death from any cause occurred in 17.7% of the reduced-dose group and 19.6% in the full-dose group, with most deaths being related to cancer. A composite outcome of recurrent symptomatic venous thromboembolism, major bleeding, or death from any cause was 19.9% in the reduced-dose group and 22.1% in the full-dose group, with HR 0.96 (non-significant). The strengths of this study included the methodology and sample size, and the limitations included only investigating a set treatment period. Overall, this study found that extended anticoagulant therapy with reduced-dose apixaban was noninferior to full-dose apixaban for recurrent VTE in patients with active cancer.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This international, double-blind, noninferiority trial enrolled patients with active cancer and VTE who had completed at least 6 months of treatment with anticoagulation (LMWH, DOAC, or VKA) and randomized them (1:1) to reduced-dose regimen of apixaban (2.5 mg twice daily, n=866) or a full-dose regimen (5.0 mg twice daily, n=900). Treatment was administered for 12 months. The most frequent sites of the primary cancer were the breast (22.7%), colorectal (15.2%), gynecologic (12.1%), and lung (11.3%). At baseline, 24.5% of patients had a lower-limb proximal deep-vein thrombosis and 75.5% had a pulmonary embolism. Through the study, recurrent VTE occurred in 2.1% in the reduced-dose group and 2.8% in the full-dose group, with HR 0.76 (95%CI, 0.41-1.41, p=0.001 for noninferiority). Clinically relevant bleeding occurred in 12.1% in the reduced-dose group and in 15.6% in the full-dose group, with HR 0.75 (95%CI, 0.58-0.97, p=0.03 for superiority). Major bleeding occurred in 2.9% in the reduced-dose group and 4.3% in the full-dose group, with HR 0.66 (95%CI, 0.40-1.10). Death from any cause occurred in 17.7% of the reduced-dose group and 19.6% in the full-dose group, with most deaths being related to cancer. A composite outcome of recurrent symptomatic venous thromboembolism, major bleeding, or death from any cause was 19.9% in the reduced-dose group and 22.1% in the full-dose group, with HR 0.96 (95% CI, 0.87-1.07). Overall, this study found that extended anticoagulant therapy with reduced-dose apixaban was noninferior to full-dose apixaban for recurrent VTE in patients with active cancer.
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