- Oral apixaban is noninferior to dalteparin for bleeding rates and in preventing recurrent venous thromboembolism in patients with cancer.
Why this matters
- Some studies of other oral anticoagulants had reported higher bleeding rates vs dalteparin in this patient population.
- Open-label noninferiority trial (N=1170).
- Patients with symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism were randomly assigned to oral apixaban (10 mg 2×/day for 7 days, then 5 mg 2×/day) or subcutaneous dalteparin (200 IU/kg 1×/day for 1 month, then 150 IU/kg 1×/day).
- Funding: Bristol-Myers Squibb-Pfizer Alliance.
- 5.6% in the apixaban group experienced recurrent venous thromboembolism vs 7.9% in the dalteparin group:
- HR, 0.63.
- P<.001 for noninferiority p=".09" superiority.>
- 3.8% of the apixaban group had a major bleeding event vs 4.0% in the dalteparin group:
- HR, 0.82 (P=.60).
- 1.9% of the apixaban group had major gastrointestinal bleeding vs 1.7% with dalteparin.
- Cumulative rate of recurrent thromboembolism or major bleeding:
- 8.9% with apixaban vs 11.4% with dalteparin.
- HR, 0.70 (95% CI, 0.45-1.07).
- Major or clinically relevant nonmajor bleeding:
- 12.2% with apixaban vs 9.7% with dalteparin.
- HR, 1.16 (95% CI, 0.77-1.75).
- Open label.