Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding.Is there a risk of major bleeding with apixaban?
Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P=0.60). Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding.Why was apixaban used in the Caravaggio trial?
In the Caravaggio trial, we wanted to assess whether oral apixaban would be noninferior to subcutaneous dalteparin, a low-molecular-weight heparin, for the prevention of recurrent venous thromboembolism in patients with cancer without increasing the risk of major bleeding.What are the exclusion criteria for apixaban use?
Exclusion criteria — which included patients’ clinical characteristics, issues related to anticoagulant treatment, bleeding risk, and standard issues from clinical trials of anticoagulant agents — are listed in the Supplementary Appendix.