Dabigatran etexilate (Pradaxa®) recommended for use within NHS Wales for venous thromboembolism (VTE) treatment and prevention in paediatric patients

All Wales Medicines Strategy Group
Dabigatran etexilate (Pradaxa®) hard capsules are recommended as an option for the treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from 8 years to less than 18 years of age.

Rivaroxaban (Xarelto®) recommended for use within NHS Wales for venous thromboembolism (VTE) treatment and prevention in paediatric patients

All Wales Medicines Strategy Group
Rivaroxaban (Xarelto®) granules for oral suspension and film-coated tablets are recommended for the treatment of VTE and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents after ≥5 days of initial parenteral anticoagulation treatment.

Safety and Efficiency of Diagnostic Strategies for Ruling Out Pulmonary Embolism in Clinically Relevant Patient Subgroups: A Systematic Review and Individual-Patient Data Meta-analysis

Annals of Internal Medicine
Review (16 studies;n=20,553) found all strategies showed acceptable safety with pretest probability–dependent D-dimer thresholds(DDTs) having both highest efficiency (EF) & highest predicted failure rate. In terms of EF, individual-patient data meta-analysis supports adapted DDTs.

Assessment of adherence, treatment satisfaction and knowledge of direct oral anticoagulants in atrial fibrillation patients

British Journal of Clinical Pharmacology
Longitudinal study (n=164) found adherence was suboptimal in 40.6% patients after 3 months and 42.6% after 6 months. Treatment satisfaction & knowledge were not associated with DOAC adherence over 6 month period. Patient education & follow-up may address identified knowledge gaps.

Comparative effects of guided vs. potent P2Y12 inhibitor therapy in acute coronary syndrome: a network meta-analysis of 61 898 patients from 15 randomized trials

European Heart Journal
Analysis (15 RCTs; n=61,898) found guided approach (platelet function or genetic testing) was the only strategy associated with reduced major adverse cardiovascular events (IRR 0.80, 95% CI 0.65–0.98) without any significant trade-off in all bleeding (IRR 1.22, 95% CI 0.96–1.55).

Association of Psoriasis With Incident Venous Thromboembolism and Peripheral Vascular Disease: A Systematic Review and Meta-analysis

JAMA Dermatology
Meta-analysis (13 cohort studies;n=12,435,982) noted increased risk for VTE (pooled HR 1.26;95% CI, 1.08-1.48) & PVD (1.27;1.16-1.40) among patients with psoriasis. This suggests need to identify & treat risk factors & caution with use of hormone-related therapies in this group.

Comparison of Ticagrelor vs Clopidogrel in Addition to Aspirin in Patients With Minor Ischemic Stroke and Transient Ischemic Attack: A Network Meta-analysis

JAMA Neurology
Review (5 RCTs; n=22,098) found both clopidogrel and aspirin (HR 0.74; 95% CrI 0.65-0.84) and ticagrelor & aspirin (0.79; 0.68-0.91) were superior to aspirin alone in the prevention of recurrent stroke & death, with no statistically significant difference between the two regimens.

Risk for Recurrent Venous Thromboembolism and Bleeding With Apixaban Compared With Rivaroxaban: An Analysis of Real-World Data

Annals of Internal Medicine
US retrospective study of adults with VTE found new users of apixaban had lower rates of recurrent VTE (HR 0.77; 95% CI 0.69 to 0.87]) and gastrointestinal and intracranial bleeding (0.60; 0.53 to 0.69) than new users of rivaroxaban.

Optimal follow-up after acute pulmonary embolism

European Heart Journal
This European position paper provides a comprehensive guide for optimal follow-up of patients with acute pulmonary embolism, proposing a holistic approach considering the whole spectrum of serious adverse events that patients may encounter in the short and long run.

How Strong Is the Evidence Supporting Thromboprophylaxis in Surgical Oncology?

Journal of Clinical Oncology
Article argues there are critical weaknesses to RCTs of pharmacologic thromboprophylaxis for patients undergoing cancer surgery underpinning guidelines, including unexplored potential for heterogeneity in endpoints, unclear effect on survival, and lack of supportive care outcomes.

Sex-influence on the time in therapeutic range (TTR) during oral anticoagulation with coumarin derivatives: Systematic review and meta-analysis

British Journal of Clinical Pharmacology
Review (22 studies; n=183,612) found link between female sex & worse oral anticoagulation control (of 15 studies analysed using TTR as binary variable: OR = 0.87; 95% CI = 0.78-0.96; p =0 .006). Authors call for further studies investigating sex-related factors influencing control.

Respiratory tract infection and risk of bleeding in oral anticoagulant users: self-controlled case series

British Medical Journal
Study (n=1208) found >2-fold increase in risk of major & clinically relevant non-major bleeding during 0-14 days after untreated respiratory tract infection for which no antibiotics were prescribed, highlighting need for further investigation into potential risks & mitigation.

FDA approves two new indications for Xarelto (rivaroxaban) in paediatric patients

Biospace Inc.
In the US rivaroxaban is now licensed for treatment of venous thromboembolism (VTE) and recurrent VTE prevention in patients from birth to <18yrs post 5 days parenteral anticoagulation and thromboprophylaxis aged ≥2yrs with congenital heart disease & undergone Fontan procedure.

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services