Pulmonary vascular disease & thromboembolism
Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO deep vein thrombosis (DVT) study
Authors' conclusion
A 12-month edoxaban regimen for cancer-associated isolated distal DVT was consistently superior to a 3-month regimen, across the edoxaban doses for the thrombotic risk.
Study context
- Population
- Patients with cancer-associated isolated distal DVT, stratified by edoxaban dose: standard 60 mg/day and reduced 30 mg/day60 mg N = 151 · standard 60 mg/day 151 · reduced 30 mg/day 450
- Comparison
- Edoxaban for 12 months vs 3 months, by edoxaban dose
- Primary endpoint
- Symptomatic recurrent VTE (cumulative incidence)
- Follow-up
- 12 months
Methodological detailspre-specified subgroup analysis
- Pre-specified subgroup analysis
Primary result
As reported in the abstract
Symptomatic recurrent VTE, by edoxaban dose subgroup
12-month vs 3-monthOdds ratio (95% CI)P value
60 mg subgroup
0.12(0.01–0.97)
P = 0.0230 mg subgroup
0.14(0.03–0.60)
P = 0.002Safety
| Outcome | 12-month (60 mg) | 3-month (60 mg) | 12-month (30 mg) | 3-month (30 mg) | OR (95% CI) | P value | |
|---|---|---|---|---|---|---|---|
| Major bleeding, by edoxaban dose subgroup · 12 months12-month vs 3-month · 60 mg subgroup | 14.3% | 4.4% | 8.7% | 8.6% | 3.61 (0.97–13.52) | P = 0.046 | |
| Major bleeding, by edoxaban dose subgroup · 12 months12-month vs 3-month · 30 mg subgroup | 0.97 (0.49–1.91) | P = 0.89 | |||||
| 0.050.21520Odds ratio (log scale) |
- Major bleeding, by edoxaban dose subgroup: interaction P = 0.07 (potential interaction)
Original publication
Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study. Eur Heart J Cardiovasc Pharmacother. Published 22 April 2024. doi:10.
Summarised from the published abstract; every number is checked against it