Extended duration of anticoagulation with edoxaban in patients with venous thromboembolism: a post-hoc analysis of the Hokusai-VTE study

Raskob, Gary E.; Ageno, Walter; Cohen, Alexander T.; Brekelmans, Marjolein P. A.; Grosso, Michael; Segers, Annelise; Meyer, Guy; Verhamme, Peter; Wells, Philip S.; Lin, Min; Winters, Shannon M; Weitz, Jeffrey I.; Büller, Harry R.

doi:10.1016/s2352-3026(16)00023-5

Cited by 57 publications

(41 citation statements)

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“…Four sensitivity analyses on recurrent VTE and major bleeding were performed: (1) studies assessing standard-intensity VKAs were excluded if median or mean time in therapeutic range was less than 65%8; (2) Hokusai-VTE was excluded because extended VTE treatment was not evaluated in a randomised fashion9; (3) two studies assessing standard-intensity VKAs with an unclear treatment period were excluded10 11; and (4) an analysis accounting for different lengths of follow-up duration was performed by modelling data into the binomial likelihood with the complementary log-log link function assuming a constant event rate for each study arm in every study.…”

Section: Methodsmentioning

confidence: 99%

Extended treatment of venous thromboembolism: a systematic review and network meta-analysis

Wang

Cameron

et al. 2018

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ObjectiveTo evaluate efficacy and safety of oral anticoagulant regimens and aspirin for extended venous thromboembolism (VTE) treatment.MethodsWe searched MEDLINE, Embase, CENTRAL and conference proceedings for randomised controlled trials studying vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) or aspirin for secondary prevention of VTE beyond 3 months. ORs (95% credible intervals) between treatments were estimated using random-effects Bayesian network meta-analysis.ResultsSixteen studies, totaling more than 22 000 patients, were included. Compared with placebo or observation and with aspirin, respectively, the risk of recurrent VTE was lower with standard-intensity VKAs (0.15 (0.08 to 0.24) and 0.23 (0.09 to 0.54)), low-dose factor Xa inhibitors (0.16 (0.06 to 0.38) and 0.25 (0.09 to 0.66)), standard-dose factor Xa inhibitors (0.17 (0.08 to 0.33) and 0.27 (0.11 to 0.65)) and the direct thrombin inhibitor (0.15 (0.04 to 0.37) and 0.23 (0.06 to 0.74)) although the risk of major bleeding was higher with standard-intensity VKAs (4.42 (1.99 to 12.24) and 4.14 (1.17 to 18.86)). Effect estimates were consistent in male patients and those with index pulmonary embolism or with unprovoked VTE and in sensitivity analyses. In addition, compared with placebo or observation, the risk of all-cause mortality was reduced with standard-intensity VKAs (0.44 (0.20 to 0.87)) and low-dose factor Xa inhibitors (0.38 (0.12 to 0.995)).ConclusionsStandard-intensity VKAs and DOACs are more efficacious than aspirin for extended VTE treatment. Despite a higher risk of major bleeding, standard-intensity VKAs was associated with a lower risk of all-cause mortality. Since overall efficacy and safety of standard-intensity VKAs and DOACs are in equipoise, patient factors, costs and patient preferences should be considered when recommending extending anticoagulation treatment.

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Section: Methodsmentioning

confidence: 99%

Extended treatment of venous thromboembolism: a systematic review and network meta-analysis

Wang

Cameron

et al. 2018

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“…This limits the available data regarding edoxaban in this setting. However, a post-hoc analysis of HOKUSAI-VTE study 37 , compared edoxaban with warfarin in those patients who continued therapy beyond 3 months and completed treatment for 12 months (40% of initially recruited patients); the incidence rate of recurrent VTE were 1.8% in the edoxaban group and 1.9% in the warfarin group (HR 0.97; 95% CI 0.69-1.37) and regarding major bleeding were 0.3% and 0.7%, respectively (HR 0.45; 95% CI 0.22-0.92). This provides additional data that edoxaban could be a safe alternative to warfarin for extended treatment in VTE.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Update on extended treatment for venous thromboembolism

et al. 2018

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The importance of assessing the probability of venous thromboembolism recurrence, a condition that includes deep vein thrombosis and pulmonary embolism, lies in the fact that it is the most important factor in deciding the duration of anticoagulant treatment. Risk of recurrence depends mostly on the presence of a risk factor for developing venous thromboembolism, with patients with unprovoked events being at the higher risk of recurrence. The risk of recurrence needs to be balanced with the risk of bleeding and the potential severity of these thrombotic and hemorrhagic events. In patients with an unprovoked venous thromboembolism who complete treatment for the acute (first 10 days) and post-acute phase of the disease (from day 10 to 3-6 months), decision has to be made regarding prolonged antithrombotic therapy to prevent recurrences. The main goal of extended treatment is preventing recurrences with a safe profile in terms of bleeding risk. Many therapeutic options are now available for these patients, including antiplatelet therapy with aspirin or direct oral anticoagulants. Moreover, apixaban and rivaroxaban at prophylactic doses have demonstrated efficacy in preventing recurrences with a low risk of bleeding.

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“…Thus, although no formal “extension study” was planned for edoxaban, the design of the Hokusai study provided the opportunity to compare edoxaban with warfarin for a prolonged treatment of VTE. In a post-hoc analysis of the study [46], the risk–benefit of anticoagulation with edoxaban compared with warfarin was evaluated in those patients who continued therapy beyond 3 months. Among patients who received edoxaban or warfarin, 88.2% ( n = 3633) and 87.2% ( n = 3594), respectively, continued treatment beyond 3 months; and 45.7% ( n = 1661) and 46.2% ( n = 1659), respectively, were treated for 12 months.…”

Section: Ten Selected Questions and Answersmentioning

confidence: 99%

Edoxaban in Atrial Fibrillation and Venous Thromboembolism—Ten Key Questions and Answers: A Practical Guide

et al. 2017

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Edoxaban is the fourth non-vitamin K antagonist oral anticoagulant now available for clinical use in the prevention of stroke/systemic embolism in atrial fibrillation (AF) and in the treatment of venous thromboembolism (VTE), after the completion of large-scale randomized comparative clinical trials with the vitamin K antagonist warfarin. Edoxaban has some peculiar pharmacological properties and outcome data. Here a group of experts in AF and VTE answers a set of questions on its practical use, trying to define the profile of patients that would be most appropriate for its use.

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Extended duration of anticoagulation with edoxaban in patients with venous thromboembolism: a post-hoc analysis of the Hokusai-VTE study

Cited by 57 publications

References 14 publications

Extended treatment of venous thromboembolism: a systematic review and network meta-analysis

Extended treatment of venous thromboembolism: a systematic review and network meta-analysis

Update on extended treatment for venous thromboembolism

Edoxaban in Atrial Fibrillation and Venous Thromboembolism—Ten Key Questions and Answers: A Practical Guide

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