Edoxaban therapy given to patients with cancer and isolated distal deep vein thrombosis (DVT) for 12 months was superior to the three-month regimen at preventing a composite outcome of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death, according to a study published in Circulation.
Researchers, led by Yugo Yamashita, MD, PhD, of Kyoto University in Japan, performed the study to identify the optimal duration of anticoagulation therapy in this population, writing that prolonged anticoagulation could potentially improve prevention of thrombotic events, but could also increase bleeding risk.
From April 2019 to June 2022, the randomized clinical trial analyzed 601 patients with cancer with isolated distal DVT across 60 institutions in Japan. The full cohort had a mean age of 70.8 years, 28% were male, and 20% had DVT symptoms at baseline.
Twelve-Month Edoxaban Appears Superior to Three-Month Edoxaban
The primary composite endpoint was symptomatic recurrent VTE and VTE-related death at 12 months, and the major secondary endpoint was major bleeding according to the International Society on Thrombosis and Hemostasis criteria. A total of 296 participants were randomized to 12-month edoxaban therapy and 305 were randomized to three-month edoxaban therapy.
Investigators reported that the primary composite endpoint occurred in three out of 296 participants (1.0%) in the 12-month edoxaban group compared with 22 out of 305 participants (7.2%) in the three-month group (odds ratio [OR], 0.13; 95% CI, 0.03-0.44).
Additionally, major bleeding occurred in 28 out of 296 patients (9.5%) in the 12-month edoxaban group compared with 22 out of 305 patients (7.2%) in the three-month group (OR, 1.34; 95% CI, 0.75-2.41). The authors reported that estimates for the primary endpoint did not differ across prespecified subgroups.
“In cancer patients with isolated distal DVT,” Dr. Yamashita and colleagues reported, “12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death.”
Reference
Yamashita Y, Morimoto T, Muraoka N, et al. Edoxaban for 12 months versus 3 months in cancer patients with isolated distal deep vein thrombosis (ONCO DVT study): an open-label, multicenter, randomized clinical trial. Circulation.2023;10.1161/CIRCULATIONAHA.123.066360. doi:10.1161/CIRCULATIONAHA.123.066360
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