Pulmonary vascular disease & thromboembolismRandomised controlled trial
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer
- Randomised controlled trial
- multinational
- investigator-initiated
- open-label
- non-inferiority
- blinded central outcome adjudication
Authors' conclusion
Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding.
Study context
- Population
- Patients with cancer and symptomatic or incidental acute proximal DVT or PE
- Participants
- 576 vs 579
- Comparison
- Oral apixaban vs subcutaneous dalteparin
- Apixabann = 576
- Dalteparinn = 579reference
- Primary endpoint
- Objectively confirmed recurrent VTE
- Follow-up
- Trial period (6 months)
Primary result
Recurrent VTE
Hazard ratio
0.63
95% CI 0.37–1.07
P < 0.001 for non-inferiority
Events by treatment group
Apixaban vs Dalteparin
HR 0.63 (95% CI 0.37–1.07); P for non-inferiority < 0.001
As reported in the abstract
Safety
| Outcome | Apixaban | Dalteparin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (principal safety outcome) | 3.8% | 4.0% | 0.82 (0.40–1.69) | P = 0.60 | |
| 0.512Hazard ratio (log scale) |
Original publication
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. Published 29 March 2020. doi:10.1056/nejmoa1915103
Summarised from the published abstract; every number is checked against it