Pulmonary vascular disease & thromboembolismRandomised controlled trial
Apixaban for Extended Treatment of Provoked Venous Thromboembolism
- Randomised controlled trial
- single-centre
- double-blind
- placebo-controlled
Authors' conclusion
Among patients with provoked VTE and enduring risk factors, low-intensity therapy with apixaban for 12 months resulted in a lower risk of symptomatic recurrent VTE than placebo, with a low risk of major bleeding.
Study context
- Population
- Adults with venous thromboembolism (VTE) after a transient provoking factor, with ≥1 enduring risk factor, after ≥3 months of anticoagulation
- Participants
- 600 adults
- Comparison
- Apixaban 2.5 mg twice daily vs placebo for 12 months
- Apixabann = 300
- Placebon = 300reference
- Primary endpoint
- First symptomatic recurrent VTE
- Follow-up
- 12 months
Primary result
Symptomatic recurrent VTE
Hazard ratio
0.13
95% CI 0.04–0.36
P < 0.001
Events by treatment group
Apixaban vs Placebo
HR 0.13 (95% CI 0.04–0.36); P < 0.001
As reported in the abstract
Further findings
events
| Outcome | Apixaban | Placebo |
|---|---|---|
| Death · no deaths attributed to CV or hemorrhagic causes | 1 | 3 |
Safety
| Outcome | Apixaban | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Clinically relevant nonmajor bleeding | 4.8% | 1.7% | 2.68 (0.96–7.43) | P = 0.06 | |
| 0.10.31310Hazard ratio (log scale) |
Nonhemorrhagic, nonfatal adverse events
events
| Outcome | Apixaban | Placebo | Estimate | P value |
|---|---|---|---|---|
| Major bleeding (ISTH; primary safety outcome) | 1 | 0 |
- Clinically relevant nonmajor bleeding: 294 per group assessed
Original publication
Apixaban for Extended Treatment of Provoked Venous Thromboembolism. N Engl J Med. Published 30 August 2025. doi:10.1056/nejmoa2509426
Summarised from the published abstract; every number is checked against it