ONCO DVT: Edoxaban For 12 Months vs. 3 Months in Patients With Cancer and DVT
In patients with cancer and isolated distal deep vein thrombosis (DVT), 12 months of anticoagulation therapy with edoxaban was superior to a duration of three months in terms of reducing thrombotic events, according to findings from the ONCO DVT trial presented at ESC Congress 2023 and simultaneously published in Circulation.
The trial randomized a total of 604 patients with active cancer and newly diagnosed isolated distal DVT to either 12 months of edoxaban or three months of edoxaban. Edoxaban was administered orally at a fixed dose of 60 mg once daily, or at a lower dose of 30 mg once daily in patients with a creatinine clearance of 30 to 50 mL/minute, or a body weight of 60 kg or less, or in those receiving concomitant treatment with a P-glycoprotein inhibitor. Patients were excluded if they were taking anticoagulation therapy at the time of randomization, had a contraindication to edoxaban, were expected to have a prognosis of three months or less, or had pulmonary embolism. The average age of participants was 70.8 years, and 72% were women. The most frequent site of cancer was the ovaries (14%) followed by the uterus (13%) and lung (11%). Remaining cancer types included the colon (9%), pancreas (8%), stomach (5%), blood (5%) and breast (5%).
The primary endpoint of symptomatic recurrent venous thromboembolism (VTE) or VTE-related death at 12 months occurred in three patients (1.0%) in the 12-month edoxaban group compared with 22 (7.2%) in the three-month edoxaban group. Major bleeding occurred in 9.5% of patients in the 12-month edoxaban group vs. 7.2% in the three-month edoxaban group. The researchers noted that prespecified subgroup analyses according to age, body weight and renal function did not affect the estimates on the primary endpoint.
"This is the first and only randomized trial to show the superiority of longer duration over shorter duration of anticoagulation therapy for reducing thrombotic events in cancer patients with isolated distal DVT," said Yugo Yamashita, MD, of Kyoto University, Japan. "We expect that the results will change practice and clinical guidelines in the cardio-oncology field."
Clinical Topics: Anticoagulation Management
Keywords: ESC Congress, ESC23, ACC International, Neoplasms, Anticoagulants, Cancer
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