Pulmonary vascular disease & thromboembolismRandomised controlled trial
Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis (ONCO DVT Study): An Open-Label, Multicenter, Randomized Clinical Trial
- Randomised controlled trial
- open-label
- adjudicator-blinded
- multicentre
- 60 institutions in Japan
Authors' conclusion
In patients with cancer with isolated distal deep vein thrombosis, 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.
Study context
- Population
- Patients with cancer with isolated distal DVT601 in ITT population
- Participants
- 604 patients
- Comparison
- Edoxaban 12 months vs 3 months
- 12-month edoxabann = 296
- 3-month edoxabann = 305reference
- Primary endpoint
- Symptomatic recurrent venous thromboembolism (VTE) or VTE-related death
- Follow-up
- 12 months
Primary result
As reported in the abstract
Odds ratio
0.13
95% CI 0.03–0.44
Events by treatment group
12-month edoxaban vs 3-month edoxaban
OR 0.13 (95% CI 0.03–0.44)
Secondary outcomes
Primary end point, prespecified subgroups
- Prespecified subgroups did not affect the estimates on the primary end point
Safety
| Outcome | 12-month edoxaban | 3-month edoxaban | OR (95% CI) | |
|---|---|---|---|---|
| Major bleeding (ISTH; major secondary end point) · 12 months | 9.5% | 7.2% | 1.34 (0.75–2.41) | |
| 0.512Odds ratio (log scale) |
Original publication
Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis (ONCO DVT Study): An Open-Label, Multicenter, Randomized Clinical Trial. Circulation. Published 28 August 2023. doi:10.1161/circulationaha.123.066360
Summarised from the published abstract; every number is checked against it