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Apixaban offers new perspective for cancer patients in need of anticoagulation

Presented by
Prof. G. Agnelli, University of Perugia, Italy
Conference
ACC 2020
Trial
Phase 3, CARAVAGGIO
Oral apixaban has shown to be non-inferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism (VTE) in the phase 3, open-label, multinational CARAVAGGIO trial [1]. Of interest was that no increase was observed in the risk of major bleeding at the gastrointestinal (GI) sites. These reassuring results, which were simultaneously 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 CARAVAGGIO trial, presented by Prof. Giancarlo Agnelli (University of Perugia, Italy), assessed whether oral apixaban (10 mg twice daily for the first 7 days, 5 mg twice daily thereafter) was non-inferior to subcutaneous dalteparin (200 IU/kg once daily for the first month and then 150 IU/kg once daily) in the treatment of proximal deep-vein thromboembolism (DVT) 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 DVT, or symptomatic or incidental PE in a segmental or more proximal pulmonary artery. The primary endpoint was recurrent proximal DVT or PE over 6 months, as assessed by a central, independent adjudication committee unaware of study treatment allocation. The primary safety outcome was major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis (ISTH). Patients were randomised to apixaban (n=585) or 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, see Table). This was 2.3% and 2.6% for recurrent DVT, and 3.3% and 5.5% for PE, respectively. Fatal PE occurred in 0.7% and 0.5% of patients, respectively. The primary safety endpoint of 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). Major GI bleeding occurred in 1.9% and 1.7% of patients, respectively. In conclusion, the CARAVAGGIO study provided compelling evidence that while apixaban could provide comparable protection from recurrence of VTE as compared with low-molecular-weight heparin, no substantial increase in bleeding hazard was observed.

Table: Primary efficacy outcomes of the CARAVAGGIO trial [1]



CI, confidence interval; DVT, deep-vein thromboembolism; PE, pulmonary embolism; VTE, venous thromboembolism.

 


    1. Agnelli G, et al. Abstract 406-09. ACC/WCC 28-30 March 2020.

    2. Agnelli G, et al. N Engl J Med. 2020; DOI: 10.1056/NEJMoa1915103.


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