Apixaban therapy is as effective as low-molecular-weight heparin (LMWH) therapy for the prevention of recurrence of venous thromboembolism (VTE) in patients with cancer, with no increase in major bleeding events. These findings from the Caravaggio trial were presented at the virtual ACC 2020 Scientific Sessions.

VTE is a common complication and a major cause of morbidity and mortality in patients with cancer. Management of VTE in these patients is challenging because the risks of recurrent thrombosis and bleeding are higher than in individuals without cancer. Major guidelines recommend LMWH as the first-line therapy for cancer-associated VTE, but LMWH requires daily subcutaneous injections. The guidelines have recently included the non-vitamin K antagonist oral anticoagulants (NOACs) edoxaban and rivaroxaban, which are more convenient to use and have been shown to be as effective as LMWH although with a higher risk of bleeding. These shortcomings and the good efficacy–safety balance of the NOAC apixaban in the general population of patients with VTE prompted Agnelli and colleagues to test this agent in the cancer setting.

The Caravaggio trial included patients with symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism who were randomly assigned to receive oral apixaban or subcutaneous LMWH (dalteparin) at standard regimens.

During the 6-month treatment period, recurrent VTE (the primary efficacy end point) occurred in 5.6% of 576 patients in the apixaban group and in 7.9% of 579 patients in the LMWH group, which met the requirement for noninferiority (HR 0.63, 95% CI 0.37–1.07, P < 0.001). The rate of major bleeding events was similar in both groups (3.8% versus 4.0%), including gastrointestinal bleeding events (1.9% versus 1.7%). Mortality was also similar in the two groups and was mostly related to cancer.

These findings reinforce the efficacy data and improve the safety data compared with other NOACs

“These findings reinforce the efficacy data and improve the safety data compared with other NOACs, and expand the proportion of patients with cancer and VTE who will be eligible for treatment with this agent, including patients with gastrointestinal cancer,” highlights Agnelli. The investigators now plan to perform subanalyses of the Caravaggio trial, including assessing drug–drug interactions. In addition, the API-CAT study to assess the efficacy and safety of apixaban beyond 6 months is ongoing.