Abstract

BackgroundDirect oral anticoagulants (DOACs) have recently been tested in multiple randomised controlled trials (RCTs) for the prophylaxis and treatment of cancer-associated venous thromboembolism (VTE) leading to changes in guidelines. To quantify the risks and benefits of DOACs in the prophylaxis and treatment of cancer-associated VTE, we performed a systematic review and meta-analysis of published RCTs.MethodsA systematic search of PubMed, Cochrane Library and Google Scholar databases for all phase-3 RCTs of DOACs in patients with cancer was conducted. Pooled estimates for the cumulative incidence of VTE, recurrent VTE, major bleeding and clinically relevant non-major bleeding (CRNMB) for each arm and pooled hazard ratio (HR) with 95% confidence intervals (CI) for VTE, recurrent VTE, major bleeding, CRNMB and overall survival were calculated by using random-effect model.ResultsSix phase-3 RCTs (N = 4341) which studied DOACs in prophylaxis or treatment of cancer-associated VTE were included. DOACs significantly reduced the risk of VTE versus placebo in prophylaxis (5% versus 9%, HR 0.51 and 95% CI:0.32–0.82) and the risk of recurrent VTE versus low-molecular-weight heparin in the treatment setting (4% versus 9%, HR 0.58 and 95% CI: 0.40–0.87) although, at a cost of increased risk of major bleeding (HR 1.46 and 95% CI: 1.0–2.12) or CRNMB (HR 1.42 and 95% CI: 1.10–1.81), there was no effect on survival (HR 1.01 and 95% CI: 0.85–1.20).ConclusionIn this meta-analysis, we found that DOACs not only significantly decreased the risk of VTE or recurrent VTE in patients with cancer but also significantly increased the risk of bleeding and CRNMB, with neither beneficial nor detrimental effects on survival. The quantification of these benefits and risks will assist in individualised shared decision-making.

Highlights

  • Venous thromboembolism (VTE) is one of the most common complications and causes of death in patients with cancer, the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer have not been straightforward for a number of reasons

  • We excluded non-trial studies, non-randomised controlled trials (RCTs) and studies conducted in population that was not specific to cancer and included only phase-3 RCTs which studied the use of Direct oral anticoagulants (DOACs) in prophylaxis or treatment of VTE in cancer patients

  • Whilst the use of DOACs did decrease the risk of developing VTE or recurrent VTE, the use of DOACs did not confer any survival advantage but came at a cost of increase in the risk of major bleeding as well as clinically relevant non-major bleeding (CRNMB) which did not translate to increased mortality either

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Summary

Introduction

Venous thromboembolism (VTE) is one of the most common complications and causes of death in patients with cancer, the prophylaxis and treatment of VTE in patients with cancer have not been straightforward for a number of reasons. A number of studies have been published recently assessing the role of direct oral anticoagulants (DOACs) in patients with cancer, both in the prophylaxis and treatment settings. This could change the balance of risks–benefits by providing a non-injection option for anticoagulation. The addition of rivaroxaban, apixaban and edoxaban to the treatment armamentarium is a major change from the previous guidelines which recommended LMWH as the treatment of choice or did not deem the benefits to outweigh the therapeutic burden for prophylaxis in ambulatory setting. Direct oral anticoagulants (DOACs) have recently been tested in multiple randomised controlled trials (RCTs) for the prophylaxis and treatment of cancer-associated venous thromboembolism (VTE) leading to changes in guidelines. To quantify the risks and benefits of DOACs in the prophylaxis and treatment of cancer-associated VTE, we performed a systematic review and meta-analysis of published RCTs

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