ONCO DVT Study; Optimal duration of anticoagulation therapy for isolated distal deep vein thrombosis in patients with cancer study

Presented at the ESC Congress 2023 by: Yugo Yamashita, MD, PhD - Kyoto, Japan

Introduction and methods

Distal deep vein thrombosis (DVT) is common in patients with cancer, and recurrence can be prevented by anticoagulation therapy. However, evidence is lacking for the optimal duration of this therapy for cancer patients with isolated distal DVT.

The ONCO DVT (Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study) trial was a multicenter, open-label, adjudicator-blinded, superiority RCT conducted in Japan. In this trial, 601 patients with active cancer and newly diagnosed isolated distal DVT were randomized to oral edoxaban 60 mg once daily (or 30 mg once daily based on reduced-dose criteria) for either 3 or 12 months.

The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) or VTE-related mortality at 12 months. Secondary endpoints included major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria) at 12 months.

Main results

• After 1 year, the primary endpoint occurred in 1.2% of the patients receiving edoxaban for 12 months and 8.5% of those taking edoxaban for 3 months (OR: 0.13; 95%CI: 0.03–0.44; P<0.001).
• The rate of major bleeding (key secondary endpoint) was 10.2% in the 12-month edoxaban group and 7.6% in the 3-month edoxaban group (OR: 1.34; 95%CI: 0.75–2.41).
• Prespecified subgroup analyses showed no significant effect modification by, for example, age, body weight, and renal function.

Conclusion

In cancer patients with isolated distal DVT, 12-month edoxaban treatment was superior to 3-month treatment in lowering the risk of symptomatic recurrent VTE or VTE-related mortality after 1 year, without increasing the bleeding risk. According to the researchers, clinical guidelines should be updated to incorporate these findings.

- Our reporting is based on the information provided at the ESC Congress -

The results of this study were simultaneously published in Circulation.