Carrier M, et al. - Among intermediate-to-high-risk ambulatory subjects with cancer who were starting chemotherapy, investigators evaluated a significantly lower rate of venous thromboembolism followed by apixaban therapy. But, a higher rate of major bleeding episodes was noticed with apixaban.

Methods

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

Results

• They involved 563 in the modified intention-to-treat analysis among 574 patients who underwent randomization.
• They observed venous thromboembolism in 12 of 288 candidates (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).
• Major bleeding took place in 10 subjects (3.5%) in the apixaban group and in 5 individuals (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P=0.046) in this modified intention-to-treat analysis.
• They noticed major bleeding in 6 subjects (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24) during the treatment period.