Caravaggio Trial: Apixaban Noninferior to Dalteparin in Treatment of Cancer-Associated VTE

Oral apixaban is noninferior to subcutaneous dalteparin for the treatment of cancer-associated recurrent venous thromboembolism (VTE), according to the results of the international Caravaggio trial, a Late-Breaking Clinical Trial presented March 29 during ACC.20/WCC and simultaneously published in the New England Journal of Medicine.

Giancarlo Agnelli, MD, et al., sought to assess in this open-label trial with blinded adjudication whether oral apixaban would be noninferior to subcutaneous dalteparin for the prevention of recurrent VTE in patients with cancer without increasing the risk of major bleeding. Recent guidelines recommend the consideration of other oral anticoagulants for the treatment of VTE in patients with cancer, but the benefits are limited due to the increased risk of bleeding associated with their use.

Participants who had symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism were randomly assigned to receive oral apixaban (10 mg twice daily for first seven days, followed by 5 mg twice daily) or subcutaneous dalteparin (200 IU/kg of body weight once daily for the first month, followed by 150 IU/kg once daily). Treatment lasted six months. The primary outcome was objectively confirmed recurrent VTE and major bleeding was the principal safety outcome.

The results of the study showed that recurrent VTE occurred in 32 of the 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37-1.07; p<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) of the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40-1.69; p=0.60).

In an accompanying editorial comment, Agnes Y. Y. Lee, MD, notes that “the evidence from the [Caravaggio and prior] trials makes a compelling case for adding apixaban as another anticoagulant option for the treatment of [VTE] in patients with cancer. But given the heterogeneity of available trials, it is inappropriate to conclude that one direct oral anticoagulant is better than another without a head-to-head comparison.” When choosing which anticoagulant to use, “[clinicians] need to rely on a detailed clinical history, ascertaining the cancer type, status, and the treatment, along with bleeding risk, concomitant medications, and the patient’s experiences and values,” says Lee.

Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Acute Heart Failure, Pulmonary Hypertension, Hypertension

Keywords: ACC Annual Scientific Session, acc20, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Hypertension, Pulmonary, Aneurysm, Heart Failure

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