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Meta-analysis of the efficacy and safety of new oral anticoagulants in patients with cancer-associated acute venous thromboembolism.
J Thromb Haemost. 2014 May 12;
Authors: van der Hulle T, den Exter PL, Kooiman J, van der Hoeven JJ, Huisman MV, Klok FA
Abstract
INTRODUCTION: Treatment of acute venous thromboembolism (VTE) in cancer patients is challenging due to a high risk of recurrent VTE and bleeding complications. Treatment of choice is low-molecular-weight heparins (LMWH), due to a proven higher efficacy than vitamin K-antagonists (VKA) and a comparable bleeding profile. The recently introduced new oral anticoagulants (NOACs) have potential to be an alternative option for these patients since these drugs share practical advantages with LMWH, are administered orally and had comparable efficacy but lower bleeding risk compared to VKA in phase 3 studies in the general VTE population.
METHODS: A systematic literature search was performed to identify phase 3 trials investigating NOACs 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) 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 rate of recurrent VTE was 4.1% (95%CI 2.6-6.0) in cancer patients treated with NOACs and 6.1% (95%CI 4.1-8.5) in patients treated with VKA, RR 0.66 (95%CI 0.38-1.2). The pooled incidence rate of major or non-major clinically relevant bleeding in cancer patients treated with NOACs was 15% (95%CI 12-18) and 16% (95%CI 9.9-22) in patients treated with VKA, 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 NOACs versus LMWH in cancer patients. This article is protected by copyright. All rights reserved.
PMID: 24819040 [PubMed - as supplied by publisher]