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Duration of anticoagulant therapy in pediatric venous thromboembolism: Current approaches and updates from randomized controlled trials.

ABSTRACT: INTRODUCTION:Compared with the incidence of venous thromboembolism in the adult population, pediatric VTE is rare. Yet, recent data suggest that the incidence of VTE in children is increasing, and little is known about the optimal duration of anticoagulation in pediatrics. Areas covered: This review summarizes current evidence-based adult recommendations and associated clinical trials from which current guidelines on the duration of anticoagulation in children have been extrapolated. It also discusses pediatric expert consensus-based guidelines and current pediatric clinical trials on duration of therapy in pediatric VTE. Expert commentary: The vast majority of pediatric VTE are provoked, and evidence on duration of anticoagulation for pediatric VTE is highly limited, but suggests that a maximum duration of 3 months is reasonable for most patients with provoked VTE, whereas longer duration is likely appropriate for unprovoked VTE. Whether shorter duration than 3 months is optimal for pediatric provoked VTE is as yet unclear. Results from the multinational randomized controlled trial studying the duration of anticoagulant therapy for provoked VTE in patients <21 years old (Kids-DOTT) will be critical to inform the future standard of care in pediatric VTE treatment.

SUBMITTER: Tarango C

PROVIDER: S-EPMC5909970 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Duration of anticoagulant therapy in pediatric venous thromboembolism: Current approaches and updates from randomized controlled trials.

Tarango Cristina C Schulman Sam S Betensky Marisol M Goldenberg Neil A NA

Expert review of hematology 20171217 1

<h4>Introduction</h4>Compared with the incidence of venous thromboembolism in the adult population, pediatric VTE is rare. Yet, recent data suggest that the incidence of VTE in children is increasing, and little is known about the optimal duration of anticoagulation in pediatrics. Areas covered: This review summarizes current evidence-based adult recommendations and associated clinical trials from which current guidelines on the duration of anticoagulation in children have been extrapolated. It ...[more]

PMID: 29183221

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Project description:BACKGROUND:Patients with unprovoked (i.e., without the presence of apparent transient risk factors such as recent surgery) venous thromboembolism (VTE) are at risk of recurrence if anticoagulants are stopped after 3-6 months, yet their risk remains heterogeneous. Thus, prolonging anticoagulant treatment should be considered in high-risk patients, whereas stopping is likely preferred in those with a low predicted risk. The Vienna Prediction Model (VPM) could aid clinicians in estimating this risk, yet its clinical effects and external validity are currently unknown. The aim of this study was to investigate the clinical impact of this model on reducing recurrence risk in patients with unprovoked VTE, compared to usual care. METHODS AND FINDINGS:In a randomized controlled trial, the decision to prolong or stop anticoagulant treatment was guided by predicted recurrence risk using the VPM (n = 441), which was compared with usual care (n = 442). Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018. The primary outcome was recurrent VTE during 24 months of follow-up. Secondary outcomes included major bleeding and clinically relevant non-major (CRNM) bleeding. In the total study population of 883 patients, mean age was 55 years, and 507 (57.4%) were men. A total of 96 recurrent VTE events (10.9%) were observed, 46 in the intervention arm and 50 in the control arm (risk ratio 0.92, 95% CI 0.63-1.35, p = 0.67). Major bleeding occurred in 4 patients, 2 in each treatment arm, whereas CRNM bleeding occurred in 20 patients (12 in intervention arm versus 8 in control arm). The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk. For instance, in 284 patients with a predicted risk of >2% to 4%, the observed rate of recurrence was 2.5% (95% CI 0.7% to 4.3%). The main limitation of this study is that it did not enroll the preplanned number of 750 patients in each study arm due to declining recruitment rate. CONCLUSIONS:Our results show that application of the VPM in all patients with unprovoked VTE is unlikely to reduce overall recurrence risk. Yet, in those with a low predicted risk of recurrence, the observed rate was also low, suggesting that it might be safe to stop anticoagulant treatment in these patients. TRIAL REGISTRATION:Netherlands Trial Register NTR2680.

Dataset Information

Duration of anticoagulant therapy in pediatric venous thromboembolism: Current approaches and updates from randomized controlled trials.

Publications

Duration of anticoagulant therapy in pediatric venous thromboembolism: Current approaches and updates from randomized controlled trials.

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