Meta‐analysis of the efficacy and safety of new oral anticoagulants in patients with cancer‐associated acute venous thromboembolism

Summary Introduction Treatment of acute venous thromboembolism ( VTE ) in cancer patients is challenging, owing to a high risk of recurrent VTE and bleeding complications. The anticoagulants of choice are low molecular weight heparins ( LMWH s), because of a proven higher efficacy than vitamin  K antagonists ( VKA s) and a similar bleeding profile. The recently introduced new oral anticoagulants ( NOAC s) have the potential to be alternative options for these patients, as these drugs share practical advantages with LMWH , are administered orally, and had similar efficacy to VKA s but a lower bleeding risk in phase 3 studies in the general VTE population. Methods A systematic literature search was performed to identify phase 3 trials investigating NOAC s for the treatment of VTE . The efficacy outcome was recurrent VTE , and the safety outcome was major and clinically relevant non‐major bleeding. Pooled incidence rates and risk ratios ( RR s) were calculated for cancer patients and non‐cancer patients separately. Results and discussion Five studies were included, with 19 060 patients, of whom 973 (5.1%) had active cancer. The pooled incidence rates of recurrent VTE were 4.1% (95% confidence interval [ CI ] 2.6–6.0) in cancer patients treated with NOAC s, and 6.1% (95%  CI  4.1–8.5) in patients treated with VKA s ( RR  0.66, 95%  CI  0.38–1.2). The pooled incidence rates of major or non‐major clinically relevant bleeding were 15% (95%  CI  12–18) in cancer patients treated with NOAC s, and 16% (95%  CI  9.9–22) in patients treated with VKA s ( RR  0.94, 95%  CI  0.70–1.3). These results form a solid basis for the initiation of a head‐to‐head comparison of NOAC s with LMWH in cancer patients.