Carrier M, et al. - In this randomized, placebo-controlled, double-blind clinical trial, experts evaluated the effectiveness and safety of apixaban for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy. A significantly lower rate of venous thromboembolism was resulted by apixaban therapy vs placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. They noted higher rate of major bleeding episodes with apixaban than with placebo.

Methods

• Researchers conducted a randomized, placebo-controlled, double-blind clinical trial evaluating the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy.
• The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days.
• A major bleeding episode was the main safety outcome.

Results

• Findings suggested that out of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis.
• As per data, venous thromboembolism occurred in 12 of 288 patients (4.2%) in the apixaban group and in 28 of 275 patients (10.2%) in the placebo group (hazard ratio, 0.41; 95% confidence interval [CI], 0.26 to 0.65; P < 0.001).
• In the placebo group, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the modified intention-to-treat analysis (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P=0.046).
• In the placebo group, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) during the treatment period(hazard ratio, 1.89; 95% CI, 0.39 to 9.24).