Edoxaban 12 months superior to 3 months for VTE prevention in cancer DVT, regardless of anemia status
This prespecified subgroup analysis of the ONCO DVT study evaluated the impact of anemia on clinical outcomes in patients with cancer-associated isolated distal deep vein thrombosis (DVT) receiving edoxaban. The analysis included 601 patients divided into anemia (n=402) and no-anemia (n=199) groups, with anemia defined as hemoglobin <12 g/dL for women and <13 g/dL for men. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) or VTE-related death. In the anemia subgroup, the primary endpoint occurred in 3 (1.5%) patients in the 12-month edoxaban treatment group and 17 (8.4%) patients in the 3-month treatment group (odds ratio [OR] 0.17; 95% confidence interval [CI] 0.05-0.58). In the no-anemia subgroup, the primary endpoint occurred in 0 patients in the 12-month group and 5 (4.9%) patients in the 3-month group (P interaction=0.997). Regarding safety, major bleeding occurred in 26 (13.1%) and 17 (8.4%) patients with anemia in the 12- and 3-month edoxaban treatment groups, respectively (OR 1.64; 95% CI 0.86-3.14). In patients without anemia, major bleeding occurred in 2 (2.1%) and 5 (4.9%) patients in the 12- and 3-month groups, respectively (OR 0.67; 95% CI 0.26-1.73; P interaction=0.13). The study concluded that regardless of anemia status, 12 months of edoxaban treatment was superior to 3 months in reducing thrombotic events, while the risk of major bleeding did not differ significantly between the two treatment durations.