Apixaban Noninferior to Subcutaneous Dalteparin for Cancer-Associated VTE

Results from the CARAVAGGIO trial showed the direct oral anticoagulant apixaban was as effective as dalteparin, a type of low-molecular-weight heparin, in preventing recurrent venous thromboembolism (VTE) in patients with cancer. Lead investigator Giancarlo Agnelli, MD, of University of Perugia in Italy, also reported that rates of major bleeding were similar between apixaban and dalteparin (3.8% vs. 4.0%, hazard ratio [HR] = 0.82; 95% CI 0.40-1.69). These findings were presented at ACC.20/WCC Virtual, the American College of Cardiology (ACC) annual meeting which was held remotely.

The CARAVAGGIO trial’s 1,170 enrolled patients were randomized to receive either:

  • apixaban 10 mg twice daily for the first 7 days, followed by 5 mg twice daily
  • subcutaneous dalteparin 200 IU/kg once daily for the first month, followed by 150 IU/kg once daily

The treatments were administered for 6 months. Overall, the VTE recurrence was 5.6% in the apixaban group, compared with 7.9% in the dalteparin group (HR=0.63; 95% CI 0.37-1.07; p<0.001). The 2 arms had similar rates of recurrent deep vein thromboembolism (2.3% vs. 2.6%; HR=0.87; 95% CI 0.34-2.21); recurrent pulmonary embolism (PE; 3.3% vs. 5.5%; HR=0.54; 95% CI 0.29-1.03); and recurrent fatal PE (0.7% vs. 0.5%; HR=1.93; 95% CI 0.40-9.41).

Limitations of the study include its open-label design and lack of statistical power on which to base definitive conclusions about bleeding risks. Further research is needed to determine the effects of apixaban taken for longer than 6 months in this patient population.

Sources: ACC press release, March 29, 2020; Agnelli G, Becattini C, Meyer G, et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med. 2020 March 29. [Epub ahead of print]