Apixaban on par with dalteparin for anticoagulation in cancer

  • Agnelli G & al.
  • N Engl J Med
  • 29 Mar 2020

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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).

Limitations

  • Open label.