Apixaban significantly reduced venous thromboembolism compared to placebo in ambulatory patients with cancer starting chemotherapy (4.2% vs 10.2%; HR 0.41; 95% CI 0.26-0.65; P<0.001).
RCT (n=574)
double-blind
randomized
Does apixaban reduce venous thromboembolism in ambulatory patients with cancer at intermediate-to-high risk initiating chemotherapy?
In ambulatory cancer patients starting chemotherapy, prophylactic apixaban significantly reduced venous thromboembolism but increased major bleeding compared to placebo.
Hazard Ratio: 0.41 (95% CI 0.26–0.65)
Absolute Event Rate: 4.2% vs 10.2%
p-value: p=<0.001
BACKGROUND: Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial assessing 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. The main safety outcome was a major bleeding episode. RESULTS: Of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis. 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 modified intention-to-treat analysis, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P = 0.046). During the treatment period, major bleeding occurred in 6 patients (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). CONCLUSIONS: Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. The rate of major bleeding episodes was higher with apixaban than with placebo. (Funded by the Canadian Institutes of Health Research and Bristol-Myers Squibb-Pfizer Alliance; AVERT ClinicalTrials.gov number, NCT02048865.).
Carrier et al. (2018) conducted an RCT in Cancer (n=574). Apixaban vs. Placebo was evaluated on Objectively documented venous thromboembolism (HR 0.41, 95% CI 0.26 to 0.65, p=<0.001). Apixaban significantly reduced venous thromboembolism compared to placebo in ambulatory patients with cancer starting chemotherapy (4.2% vs 10.2%; HR 0.41; 95% CI 0.26-0.65; P<0.001).