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.
If you have cancer and develop a blood clot in your leg, you're often also dealing with anemia, which is low red blood cell count. This can make treatment decisions tricky. A new analysis looked at whether a blood thinner called edoxaban works differently for these patients depending on how long they take it.
The study involved 601 patients, most of whom had anemia. It compared taking the medication for 12 months versus just 3 months. The goal was to see which approach better prevented another dangerous clot. In patients with anemia, 1.5% of those on the 12-month treatment had another clot or died from one, compared to 8.4% of those on the 3-month treatment. In patients without anemia, the rates were 0% and 4.9%, respectively. This shows that the longer treatment was better at preventing clots in both groups.
When it came to the risk of serious bleeding, the study found no significant difference between taking the drug for 12 months or 3 months, regardless of whether a patient had anemia. This means that for cancer patients with this specific type of leg clot, a full year of treatment offers stronger protection against another clot without a clear increase in major bleeding risk, even if they have anemia.
What this means for you: For cancer patients with a leg clot, a year of blood thinners beats three months, whether or not they have anemia.
View Original Abstract ↓
BACKGROUND: The ONCO DVT study demonstrated potential benefits of extended edoxaban treatment in patients with isolated distal deep vein thrombosis in terms of thrombotic risk. However, the risk-benefit balance in patients with anemia remains unclear.
METHODS AND RESULTS: This prespecified subgroup analysis included 601 patients, divided into anemia (n=402) and no-anemia (n=199) groups. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) or VTE-related death. Anemia was defined as hemoglobin <12 g/dL for women and <13 g/dL for men. In the anemia subgroup, the primary endpoint occurred in 3 (1.5%) and 17 (8.4%) patients in the 12- and 3-month edoxaban treatment groups, respectively (odds ratio [OR] 0.17; 95% confidence interval [CI] 0.05-0.58), compared with 0 and 5 (4.9%) patients, respectively, in the no-anemia subgroup (P interaction=0.997). 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), compared with 2 (2.1%) and 5 (4.9%) patients without anemia (OR 0.67; 95% CI 0.26-1.73; P interaction=0.13).
CONCLUSIONS: Regardless of the presence of anemia, edoxaban treatment for 12 months was superior to treatment for 3 months in reducing thrombotic events, whereas the risk of major bleeding did not differ significantly between the 2 treatment groups.