Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study - ONCO DVT

Contribution To Literature:

The ONCO DVT trial showed that among patients with active cancer who have either symptomatic or asymptomatic distal DVT, anticoagulation with edoxaban for 12 months is superior to 3 months in reducing recurrent symptomatic VTE without increasing the risk of bleeding.


The goal of the trial was to compare the safety and efficacy of 3 versus 12 months of treatment with edoxaban for patients with active cancer who were noted to have a distal deep vein thrombosis (DVT).

Study Design

Eligible patients were randomized in a 1:1 open-label fashion to edoxaban for 12 months (n = 296) or 3 months (n = 305). The treatment dose of edoxaban was 60 mg, but it was dose-reduced to 30 mg in 75% of patients due to either creatinine clearance of 30-50 mL/min or a body weight of ≤60 kg or due to concomitant treatment with potent P-glycoprotein inhibitors.

  • Total number of enrollees: 601
  • Duration of follow-up: 12 months
  • Mean patient age: 71 years
  • Percentage female: 72%

Inclusion criteria:

  • Adult patients with active cancer
  • Newly diagnosed with isolated distal DVT confirmed by ultrasonography

Exclusion criteria:

  • Patients on anticoagulation therapy at the time of the diagnosis
  • Patients with a contraindication for edoxaban
  • Patients with pulmonary embolism (PE)
  • Patients expected to have a life prognosis of ≤3 months by the treating physicians

Other salient features/characteristics:

  • Body weight: 55 kg
  • Symptoms at baseline: 20%
  • The most common type of cancer was gynecologic cancer (28%), followed by lung cancer (11%) and colon cancer (10%)
  • The most common reason for conducting ultrasonography was due to a high-risk status with elevated D-dimer levels (38%), followed by elevated D-dimer levels before surgery (24%) and suspected DVT based on the symptoms (20%)

Principal Findings:

The primary endpoint, symptomatic recurrent venous thromboembolism (VTE) or VTE-related death, for 12 vs. 3 months of edoxaban, was: 1.0% vs. 7.2% (odds ratio [OR] 0.13, 95% confidence interval [CI] 0.03-0.44). There were no VTE-related deaths.

Symptomatic recurrent VTE consisted of three PEs including two PEs with hypoxia, and 22 DVTs including seven proximal DVTs and 14 isolated distal DVTs.

Secondary outcomes for 12 vs. 3 months of edoxaban:

  • Major bleeding: 9.5% vs. 7.2%, (OR 1.34, 95% CI 0.75-2.41); the majority of bleeding was gastrointestinal bleeding
  • New or worsening thrombus images in any imaging tests during follow-up without any symptoms: 7.8% vs. 15% (p < 0.05)
  • All-cause mortality: 22% vs. 25%


The results of this trial indicate that among patients with active cancer who have either symptomatic or asymptomatic distal DVT, anticoagulation with edoxaban for 12 months was superior to 3 months. This reduced recurrent symptomatic VTE without increasing the risk of bleeding.

These are important findings. Current guidelines provide a weak recommendation for anticoagulation in this scenario (isolated distal DVT with active cancer). An important caveat to this trial is that the trial was performed in Japan and the average body weight was ~55 kg. The vast majority of patients had their dose reduced to 30 mg/day, which may explain similar bleeding rates (although numerically higher) despite the use of longer duration anticoagulation. It is unclear if this would be generalizable to other populations. Since only 20% of patients were symptomatic with their distal DVT, it also raises the question of whether routine surveillance in these patients may be of benefit. Thromboprophylaxis in this setting is another parallel issue that is important and may be especially relevant for certain malignancies (e.g., pancreatic) or metastatic disease.


Yamashita Y, Morimoto T, Muraoka N, et al., on behalf of the ONCO DVT Study Investigators. 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;Aug 28:[Epub ahead of print].

Presented by Dr. Yugo Yamashita at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 28, 2023.

Clinical Topics: Anticoagulation Management, Cardio-Oncology, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism

Keywords: Anticoagulants, Cardiotoxicity, ESC Congress, ESC23, Hemorrhage, Neoplasms, Pulmonary Embolism, Vascular Diseases, Venous Thromboembolism, Venous Thrombosis

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