Highlights from

ACC 2020

Together with World Congress of Cardiology

Virtual 28 - 30 March 2020

Apixaban offers new perspective for cancer patients in need of anticoagulation

Oral apixaban has shown to be non-inferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism (VTE) in the phase 3, multinational CARVAGGIO trial [1]. Of particular interest was that there was no increase in the risk of major bleeding at the gastrointestinal (GI) sites. These reassuring results, which were simultaneously presented at ACC/WCC 2020 and published in the New England Journal of Medicine, open up opportunities for patients with cancer-associated thrombosis who are eligible for treatment with direct oral anticoagulants (DOACs), including patients with GI cancer [2].

Patients with cancer run a high risk of recurrent VTE and bleeding. Although major guidelines recommend low molecular weight heparin and have recently added edoxaban and rivaroxaban, the high risk of bleeding (mainly at GI sites) poses a serious issue and limits the clinical benefit of these drugs. The CARVAGGIO trial, presented by Prof. Giancarlo Agnelli (University of Perugia, Italy), assessed whether oral apixaban was non-inferior to subcutaneous dalteparin in the treatment of proximal deep-vein thromboembolism and/or pulmonary embolism (PE) in patients suffering from cancer. The study was conducted in Europe, Israel, and the United States and enrolled 1,170 patients with cancer who had newly diagnosed, objectively confirmed symptomatic or incidental proximal lower-limb deep-vein thromboembolism, or symptomatic PE, or incidental PE in a segmental or more proximal pulmonary artery. The primary endpoint was recurrent proximal deep-vein thromboembolism or PE over 6 months. Patients were randomised to apixaban (n=585) and dalteparin (n=585). Baseline characteristics were comparable between both groups. The most common type of cancer was colorectal cancer, followed by lung cancer and breast cancer.

Recurrent VTE occurred in 5.6% of apixaban patients and 7.9% of dalteparin patients (HR 0.63; 95% CI 0.37-1.07; P<0.001 for non-inferiority and P=0.08 for superiority). This was 2.3% and 2.6% for recurrent VTE, and 3.3% and 5.5% for PE, respectively. Fatal PE occurred in 0.7% and 0.5% of patients, respectively. Major bleeding was observed in 3.8% of patients on apixaban and 4.0% of patients on dalteparin (HR 0.82; 95% CI 0.40-1.69; P=0.60). Regarding major GI bleeding, the rates were 1.9% and 1.7%, respectively.

  1. Agnelli G, et al. Apixaban For The Treatment Of Venous Thromboembolism Associated With Cancer: The CARAVAGGIO Study. Abstract 406-09. ACC/WCC 28-30 March 2020.
  2. Agnelli G, et al. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020; DOI: 10.1056/NEJMoa1915103

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