Abstract
BackgroundThis study sought to investigate the relative efficacy and safety of non-vitamin K oral anticoagulants (NOACs) for the treatment of venous thromboembolism (VTE) in cancer patients.MethodsA systematic search of the PubMed, EMBASE, and ClinicalTrials.gov databases identified all multicentre, randomised phase III trials investigating the initial use of NOAC against a vitamin K antagonist (VKA) together with subcutaneous heparin or low molecular weight heparin (upstart) for treatment of VTE. Outcomes of interest were recurrent VTE (deep venous thrombosis or pulmonary embolism), and clinically relevant bleeding.ResultsFour randomised controlled phase III trials were included, comprising a total of 19,060 patients randomised to either NOAC or VKA. For patients with active cancer (N = 759), the analysis on the efficacy outcomes demonstrated a trend in favour of NOAC (OR 0.56, 95% CI 0.28–1.13). Similar, analyses on the safety outcomes comparing NOAC to VKA and enoxaparin demonstrated a trend in favour of NOAC (OR 0.88, 95% CI 0.57–1.35).ConclusionPoint estimates of the effect size suggest an important estimated beneficial effect of NOAC in the treatment of VTE in cancer, in terms of efficacy and safety, but given the small numbers of patients with cancer in the randomised trials, statistical significance was not achieved.
Highlights
Analyses on the safety outcomes comparing non-vitamin K oral anticoagulants (NOACs) to vitamin K antagonist (VKA) and enoxaparin demonstrated a trend in favour of NOAC
Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in considerable long-term morbidity and mortality and affects more than 1.6 million individuals each year across the United States and the European Union [1,2,3]
This study showed that dalteparin was more effective than an oral anticoagulant in reducing the risk of recurrent thromboembolism without increasing the risk of bleeding
Summary
Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in considerable long-term morbidity and mortality and affects more than 1.6 million individuals each year across the United States and the European Union [1,2,3]. Invasive procedures as part of the investigation or treatment of cancer, such as chemotherapy, increase the risk of complications and are likely to cause thrombocytopenia and other serious side effects. This can lead to the need for delayed or reduced dosing in VKA therapy with implication of efficacy of the anti-thrombotic treatment. This study sought to investigate the relative efficacy and safety of non-vitamin K oral anticoagulants (NOACs) for the treatment of venous thromboembolism (VTE) in cancer patients. Conclusion: Point estimates of the effect size suggest an important estimated beneficial effect of NOAC in the treatment of VTE in cancer, in terms of efficacy and PLOS ONE | DOI:10.1371/journal.pone.0114445 December 5, 2014
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