Pulmonary vascular disease & thromboembolismRandomised controlled trial
Extended treatment of venous thromboembolism with reduced-dose versus full-dose direct oral anticoagulants in patients at high risk of recurrence: a non-inferiority, multicentre, randomised, open-label, blinded endpoint trial
- Randomised controlled trial
- non-inferiority
- investigator-initiated
- multicentre
- open-label
- blinded endpoint
- 47 hospitals in France
Authors' conclusion
In patients with venous thromboembolism requiring extended anticoagulation, reduction of the direct oral anticoagulant dose did not meet the non-inferiority criteria.
Study context
- Population
- Adults with acute symptomatic VTE (PE or proximal DVT) at high risk of recurrence, after 6–24 months of full-dose anticoagulation, with extended anticoagulation indicatedmedian follow-up 37.1 months
- Participants
- 2,768 adults
- Comparison
- Reduced-dose vs full-dose DOAC for extended VTE treatment
- Reduced dosen = 1,383
- Full dosen = 1,385reference
- Primary endpoint
- Symptomatic recurrent VTE (fatal or non-fatal PE or isolated proximal DVT); non-inferiority margin HR 1.7
Primary result
As reported in the abstract
Recurrent VTE · 5-year cumulative incidence
Each group vs full doseAdjusted hazard ratio (95% CI)P value
Reduced dose
1.32(0.67–2.60)
P = 0.23for non-inferiorityEach group vs full doseAbsolute difference, % (95% CI)
Reduced dose
0.40(−1.05 to 1.85)
Non-inferiority margin 1.7 as printed, not drawn
Secondary outcomes
| Outcome | Reduced dose | Full dose |
|---|---|---|
| All-cause death · 5-year cumulative incidence | 4.3% (95% CI 2.6–6.0) | 6.1% (95% CI 4.3–8.0) |
Safety
| Outcome | Reduced dose | Full dose | adjusted HR (95% CI) | |
|---|---|---|---|---|
| Major or clinically relevant bleeding · 5-year cumulative incidence | 9.9% (95% CI 7.7–12.1) | 15.2% (95% CI 12.8–17.6) | 0.61 (0.48–0.79) | |
| 0.512Adjusted hazard ratio (log scale) |
Adverse events
Serious adverse events
Original publication
Extended treatment of venous thromboembolism with reduced-dose versus full-dose direct oral anticoagulants in patients at high risk of recurrence: a non-inferiority, multicentre, randomised, open-label, blinded endpoint trial. Lancet. Published 1 March 2025. doi:10.1016/s0140-6736(24)02842-3
Summarised from the published abstract; every number is checked against it